• Letter of Intent (LOI) must be RECEIVED by October 6, 2023.
• Application must be RECEIVED by December 6, 2023.

A Letter of Intent (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. We strongly recommend sending the LOI 60 days before the application due date with a current draft of your specific aims so that NIH scientific/research contacts can review your ideas and specific aims before an application is submitted. All proposed specific aims must address research questions that are within the regulatory authority of the FDA CTP and specific to this RFA to be deemed responsive. Applications that are non-responsive will not be reviewed.

Suggested content of the LOI:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the Program Director(s) (PD(s))/Principal Investigator(s) (PI(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: TRSP@nih.gov
Tobacco Regulatory Science Program
Office of Disease Prevention
Tel: 301-451-7464

Yes, it is recommended that applicants communicate with the appropriate scientific/research contact listed in Section VII. Agency Contacts as early as possible. Also, it is important to note that an LOI is not required, not binding, and not part of the review of an application.

The applications will be reviewed by an NIH Center for Scientific Review (CSR) Special Emphasis Panel and reviewers will be recruited per the type of expertise needed. If you feel that specific expertise is needed, you may include the type of expertise you recommend in a cover letter when submitting your application. You should not include names of any individuals as the CSR would deem those individuals in conflict.

As stated in the RFA, funding decisions are based on scientific merit, availability of funds, and relevance of the proposed project to program priorities.

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 both:

1. Fall within the scope of the FDA CTP’s regulatory authorities
2. Address the Research Objectives that are listed in the RFA

In addition, no aim(s) may address the non-responsive research topics outlined in the RFA.

Applicants are strongly encouraged to contact the scientific/research contact listed in the RFA for feedback about responsiveness before submitting an application. Sharing your ideas and specific aims along with your LOI before submitting an application will allow NIH staff to provide feedback about responsiveness.

If your application is deemed responsive, it will undergo scientific peer review by experts convened specifically for that purpose (by the NIH CSR). If your application is deemed non-responsive, it will be withdrawn before evaluation of its scientific merit (i.e., peer review). Program officials will let you know if the application must be withdrawn before peer review.

The Family Smoking Prevention and Tobacco Control Act amended the Food, Drug, and Cosmetic Act to provide FDA authority over the manufacture, marketing, and distribution of tobacco products to protect public health. This gives FDA CTP the responsibility and regulatory authority for:

• Premarket review of new and modified risk tobacco products
• Post-market surveillance
• Product standards
• Reporting of ingredients
• Reporting of harmful and potentially harmful constituents
• Adverse event reporting
• Health warnings
• Advertising and promotion restrictions
• User fees

For more information about these authorities, see Family Smoking Prevention and Tobacco Control Act - An Overview.

In general, FDA CTP’s regulatory authorities do not extend to:

• Setting tax rates for tobacco products
• Regulating therapeutic products, such as those marketed to treat tobacco dependence (regulated by other parts of FDA)
• Setting clean indoor air policies
• Regulating tobacco growing
• Requiring the reduction of nicotine yields to zero
• Providing cessation services, such as behavioral and therapeutic interventions.
• Prohibiting all cigarettes, smokeless tobacco products, little cigars, other cigars, pipe tobacco, or roll-your-own tobacco products
• Public opinion polls about current, potential, or proposed tobacco regulations

Note that this RFA seeks applications that address some, but not all, areas within FDA CTP’s regulatory authorities. Please examine the RFA closely for the relevant areas to be addressed in your application. However, for more examples of the general types of research considered responsive versus non-responsive under FDA CTP’s regulatory authorities, see the FAQs document addressing general responsiveness questions. 

Applicants must address the following Research Objectives as specified in the RFA:

The research to understand the impact of continuum of risk messaging must be conducted among adult users of tobacco products and youth, as described in areas 1 and 2 below. Participants must represent a mix of demographic characteristics (e.g., age, race, ethnicity, gender identity, sexual orientation, disability status, region/location and/or socio-economic status), so that study findings can be interpreted at the general population level. To examine the impact of messaging on adult subgroups, the studies may choose to segment adult populations by motivation to quit (e.g., those who do not intend to quit vs. those who intend to quit; those who are not ready to quit vs. those who are ready to quit; those who are not open to quitting vs. those who are open to quitting), while measuring sociocultural and contextual factors that are barriers to quitting. Additionally, the research should provide findings and insights for groups that experience tobacco-related health disparities where possible, such as conducting adequately-powered subgroup analyses. Other populations such as specific sociocultural or demographic subgroups, pregnant women, or people with chronic health conditions (e.g., cardiovascular disease) may be included, but if so, must be a secondary focus.

Investigators must address all areas below (i.e., 1a, b, c and 2a, b, c) to be responsive to this RFA.

1. Quantitative studies that examine effect of exposure to messaging about the tobacco product continuum of risk among adults who use combustible tobacco products. Additionally, the research must provide findings and insights for the following subgroup: adults who use combustible products and have not yet been able to quit. The studies must assess the effect of exposure to messaging about the continuum of risk on:
   1. Message receptivity (e.g., perceived effectiveness, emotional response, psychological reactance to messaging), AND
   2. Precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, change in intentions, motivation to quit at follow-up(s) compared to baseline), AND
   3. Tobacco use behaviors (e.g., cessation, dual/poly use, partial reduction in tobacco product use, and complete switching/substitution behaviors) measured with at least one 6-month follow-up timepoint post exposure to messaging.
2. Quantitative studies that examine the effect of exposure to messaging about the tobacco product continuum of risk among other population(s) that could be impacted by messaging. These studies must include both youth (or proxies) who have never used tobacco products and youth (or proxies) who currently use non-combustible tobacco products. Applicants may propose to include proxies for certain youth populations (e.g., young adults aged 18-21 years old), if they provide adequate justification for why they are appropriate proxies and describe how findings can be extrapolated to youth. In addition, studies may include other populations such as adults who formerly used tobacco products; adults who have never used tobacco products; or adults who currently use non-combustible products but have never initiated combustible product use. The studies must assess the effect of exposure to messaging about the continuum of risk on:
   1. Message response (e.g., emotional response, perceived relevance), AND
   2. Precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, intentions, change in motivation to quit at follow-up(s) compared to baseline), AND
   3. Tobacco use behaviors (e.g., cessation, initiation, dual/poly use, and completely switching/substitution behaviors) measured with at least one 6-month follow-up timepoint post exposure to messaging

While a major component of this study will be testing continuum of risk messages and stimuli provided by FDA, applicants may also propose to adapt FDA provided stimuli/messaging and/or develop additional stimuli/messaging for testing.

FDA-provided messaging may be in the form of text-only (messages) and/or text and imagery (concepts). The stimuli are not intended to be health warning labels with graphics or for product packaging. While a major component of this study will be testing continuum of risk messages and stimuli provided by FDA, applicants may also propose to adapt FDA provided stimuli/messaging and/or develop additional stimuli/messaging for testing.

The FDA-provided stimuli may include, but are not limited to, messaging related to the following topics:

• Education around the role of combustion in tobacco-related harm
• Education around nicotine (specifically that nicotine is not the main driver of harm in tobacco products)
• Education around safety/effectiveness of FDA-approved nicotine replacement therapy
• Harm reduction that may occur when adult smokers completely switch to use of less harmful tobacco products
• Harm reduction that may occur when adult smokers significantly reduce cigarette smoking

Yes, applicants may propose hypothetical messages in their proposed studies to provide reviewers an idea of the results that would be generated and how they inform the research goal of the RFA. Please also note that, as stated previously, while applicants must test continuum of risk messages and stimuli provided by FDA, applicants may also propose to adapt FDA provided stimuli/messaging and/or develop additional stimuli/messaging for testing.

FDA would be interested in multiple types of comparisons including message vs. message and message vs. control.

Examples of message vs. message comparisons may include varying specific terminology (e.g., “switching” vs. “transitioning”) and pictorials or imagery (e.g., visual depictions of the continuum of risk), to assess impact to message receptivity and comprehension.

An example of message vs. control testing could be participants randomized to the control condition who would not view a message about the tobacco product continuum of risk. Alternatively, the investigators and the government could collaboratively establish an appropriate control condition.

Additionally, FDA would be interested in within-person comparisons to understand how, over time, exposure to messaging about the tobacco product continuum of risk impacts precursors to behavior (e.g., risk perception, beliefs, comprehension, susceptibility, change in intentions, motivation to quit at follow-up(s) compared to baseline) and tobacco use behaviors (e.g., cessation, dual/poly use, partial reduction in tobacco product use, and complete switching/substitution behaviors). For tobacco use behaviors, the within-person comparison must include at least one six-month (or more) follow-up timepoint or more post-exposure to messaging.

Yes, this would be permitted.

Yes, these groups are overlapping. The intention was to highlight the fact that some adults who smoke combustible tobacco products will have tried to quit multiple times. These individuals may benefit from a variety of strategies and supports, including additional information about the continuum of risk. Please also note that the RFA allows for researchers to consider other groups of interest, so you may decide there is another group of interest you also want to include in your study.

Message receptivity is the term used to describe how open the intended audience is to a message. Message receptivity is a multidimensional construct that may be measured via several variables, including perceived message effectiveness, emotional response, and psychological reactance. Message response is the term used in the RFA to indicate the response other audiences (e.g., youth or adult never tobacco users) may have to the messaging and includes measures such as emotional response and perceived relevance.

No, OMB approval would not be needed for this because the research would be conducted through a grant.

Although the following research topics may be within FDA CTP’s regulatory authorities to fund, they are not included in this NOFO and will be deemed non-responsive:

• Studies that only focus on modified risk tobacco products and modified risk claims as defined in section 911 of the Federal Food, Drug, and Cosmetic Act
• Descriptive studies of consumer risk and harm perceptions that do not also examine the impact of exposure to messaging on tobacco use behaviors
• Studies that develop, test, or evaluate health warning labels with graphics
• Studies that develop, test, or evaluate packaging claims or descriptors found on packaging
• Studies that examine non-tobacco products (e.g., cannabis or alcohol) on the continuum of risk for tobacco products
• Studies that focus on risk and harm perceptions of nicotine replacement therapies (NRT), unless examined in comparison to tobacco products
• Studies that focus on low nicotine content (LNC) or very low nicotine content (VLNC) tobacco products.

All proposed research specific aims must be within the regulatory authority of the FDA CTP in order to be deemed responsive to this NOFO. Applications that are non-responsive will not be reviewed. As such, potential applicants are strongly encouraged to discuss responsiveness with the agency contacts named in Section VII of this RFA. Additional information, including FAQs and webinar announcements, can be found at prevention.nih.gov/tobacco.

FDA has a strong interest in populations experiencing health inequities as it relates to tobacco-related health disparities. This is reflected in the NOFO, which indicates that “the research should provide findings and insights for groups that experience tobacco-related health disparities where possible, such as conducting adequately-powered subgroup analyses.”

However, FDA must understand the potential impact of messaging on the continuum of risk at the general population level to understand the risks and benefits of such messaging. For instance, a potential positive impact of this messaging may be that exposing adults who use combustible tobacco products who have not yet been able to quit to messaging about the continuum of risk for tobacco products may result in higher likelihood of completely switching to a lower risk non-combustible tobacco product. Alternatively, exposure to such messaging may also lead to negative effects, such as increasing initiation of these tobacco products among youth, inadvertently promoting multiple tobacco product use, and initiation of tobacco products among adults who formerly smoked.

As such, data that informs our understanding of the impact of such messaging for the whole of the population is important, and data for this research must represent a mix of demographic characteristics (e.g., age, race, ethnicity, gender identity, sexual orientation, disability status, region/location, and/or socio-economic status), so that study findings can be interpreted at the general population level. Additionally, to be responsive, the research must be conducted among adult users of tobacco products and youth as specifically described in the RFA.

Geographic diversity alone would not be a primary focus. However, geographic diversity may be included as part of research best practices, such as setting soft quotas for participants in major United States geographic regions (e.g., no more than 35% of the sample from a specific geographic region).

There are no preferences for setting of data collection, though researchers should propose a study design that can lead to understanding the potential impact of messaging on the continuum of risk across the U.S. population.

To be responsive, this research must test continuum of risk messages and stimuli (with both text and visual components) to be provided by FDA. In addition to testing messaging and stimuli provided by FDA, the research may also choose to adapt FDA-provided stimuli/messaging and/or develop additional stimuli/messaging for additional testing, as appropriate. Any proposed messaging or stimuli for testing must rely on and present evidence-based scientific information. Applications may propose to conduct qualitative research, such as focus groups or in-depth interviews to assess comprehension, reactions, and responses to FDA-provided stimuli/messaging and/or researcher-developed stimuli/messaging on the continuum of risk for tobacco products.

Currently, FDA is still considering the various formats of the messaging and there are no predetermined mediums or channels. Studies are not required to test the effectiveness of messaging by or on specific communication modes, channels, or platforms. However, if in order to further the RFA's goals, your study incorporates elements that also test communication channels, then this could be responsive, but this is contingent on the specifics of the application.

The main point of the RFA is not to establish the best communication channel for the messaging but instead to conduct quantitative studies that examine the effect of exposure to messaging about the tobacco product continuum of risk among adults who use combustible tobacco products (including those unable to quit) as well as to conduct studies to examine the effect of exposure to messaging about the tobacco product continuum of risk among other population(s) that could be impacted by messaging. These studies must assess factors described in the RFA including precursors to behavior, tobacco use behaviors, and message receptivity and response as appropriate. As such, we recommend that applications focus on these topics first (i.e., identifying effective messaging content and understanding its impact on different populations).

Therefore, studies are not required to test the effectiveness of messaging by or on specific communication modes, channels, or platforms. However, if in order to further the RFA’s goals, your study incorporates elements that also test the effect of a particular communication channel, then it could be responsive, but this is contingent on the specifics of the application.

Please note that studies that develop, test, or evaluate packaging claims or descriptors on packaging would not be responsive.

The NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” As this definition can apply to studies that investigators may not have previously considered to be a “clinical trial,” we highly recommend investigators review the resources available at grants.nih.gov/policy/clinical-trials/definition.htm. Located at this site are Case Studies, FAQs, and a Decision Tree that will help determine if your investigation is considered a clinical trial or not. Additionally, investigators are encouraged to discuss proposals and research ideas with the appropriate scientific/research contacts listed in Section VII of the Notice of Funding Opportunity (NOFO) to which you plan on applying.

No, foreign institutions are not eligible to apply, including Non-domestic (non-U.S.) Entities (Foreign Institutions) and Non-domestic (non-U.S.) Components of U.S Organizations. However, Foreign Components, as defined by the NIH Grants Policy Statement (see Chapter 16) are allowed. Note that justification for foreign collaboration and applicability of the research to U.S. regulations would need to be included.

Yes. In general, NIH intramural researchers may collaborate or consult with extramural researchers who apply for a U01 award. However, NIH intramural investigators may not receive salary support through the grant award. See Chapter 17 of the NIH Grants Policy Statement for more information.

No, applicants are not subject to a maximum allowable percentage of work that can be subcontracted from the applicant organization. NIH policy requires that the grantee is the one responsible and accountable for the performance of the grant. The grantee must perform a substantive role in the planned research and cannot simply be a conduit of funds to another party. This includes providing appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. However, depending on the nature of the science, it is possible that it would be appropriate for the consortia budget (i.e., subcontracts) to account for a larger portion of the requested budget. In short, there is no cap on subcontracts.

The budget cap is $2.5 million total costs per year for up to four years. Proposed budgets cannot exceed the budget cap, and applications exceeding the budget cap risk being returned as non-responsive.

No, escalation or inflation costs should not be included in the application. Only costs required by the work needed for the study should be included. Changes in cost due to level of effort changes and fluctuations associated with the science performed will be honored. Applicants should request what is needed to complete the work proposed. Grants management will make any necessary modifications according to current funding guidelines if the application is selected for award. Specific questions regarding an application’s budget should be directed to the appropriate financial/grants management contact listed in Section VII of the RFA.

The Public Health Communication Messaging about the Continuum of Risk for Tobacco Products grant will be assigned to the National Cancer Institute (NCI).

This NIH RFA uses a cooperative agreement U grant mechanism. It is not a contract mechanism; it is a grant mechanism. The U mechanism allows for substantial involvement between federal partners and the grantee. The intention is not for the federal partners to lead the work; the work is led by the Principal Investigator(s). The intention is that federal partners will not assume direction, prime responsibility, or a dominant role in the activities. However, working jointly with the awardee, the federal partners will help support and stimulate the research aims. Within the RFA it is further clarified that: “Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.”

No. A Mid-Period Progress Report (MPPR) will be due every six months following the project start date, in addition to the annual progress report and all grant close-out reports required by the NIH. The special reporting requirements will be listed as special terms of the award on the grantee’s Notice of Award letter.

Yes. This includes exclusion from the Streamlined Noncompeting Award Process, which means that all carryover requests require prior approval from both NIH and FDA CTP. These special requirements will be listed as special terms of the award on the grantee’s Notice of Award letter.

The award made under the RFA “Public Health Communication Messaging about the Continuum of Risk for Tobacco Products” is awarded as an NIH grant and, as such, the grantee Institution/PI is ultimately responsible for the work. That said, the grant funding mechanism is a cooperative agreement and, as such, there will be substantial scientific involvement from federal partners. Within the RFA it is further clarified that: “Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.”

The PhenX Toolkit is a web-based catalog of freely-available standard measures easily incorporated into research studies. The measures span many scientific domains and include Specialty Collections in Tobacco Regulatory Research (TRR). As noted in NOT-OD-17-034, the TRR Collections provide a common set of recommended measures that, when incorporated across studies, will facilitate data sharing, comparing, and integration, as well as replication and validation of findings. The measures included in the PhenX Toolkit were identified by working groups of experts within each of the scientific domains, followed by outreach to the relevant scientific communities to establish a consensus for the prioritized, recommended measures. PhenX measures are typically well-established, broadly validated, and low-burden to the participant and investigator. The TRR Collections include standard measures like the Fagerstrom Test for Nicotine Dependence and questions found in large and/or nationally representative surveys like the Population Assessment of Tobacco and Health (PATH) Study and the National Youth Tobacco Survey (NYTS). For more information about the TRR Collections in the PhenX Toolkit, see the PhenX website.

The NIH provides multiple resources for applicants with submission questions. Below is a list of resources, depending on the type of question being asked:

• For questions regarding Grants.gov registration and submission, as well as downloading forms and application packages, please contact Grants.gov Customer Support at support@grants.gov.
• For questions regarding application instructions, process, and finding additional NIH grant resources, please contact GrantsInfo at GrantsInfo@nih.gov.
• For questions regarding the Application Submission System & Interface for Submission Tracking (ASSIST), electronic Research Administration Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, and post-submission issues, please contact Finding Help Online. Telephone: 301-402-7469 or 866-504-9552 (toll free).
• For peer review questions, email the CSR at FOAReviewContact@CSR.NIH.gov.
• For financial/grants management questions, please contact Crystal Wolfrey, NCI, at Crystal.Wolfrey@nih.gov.
• For scientific and responsiveness questions, please contact Dr. Maria Roditis at Maria.Roditis@nih.gov.