Interventions to Prevent Electronic Nicotine Delivery Systems (ENDS) Use Among Adolescents (R01 - Clinical Trial Optional) | RFA DA 21 009

Frequently Asked Questions (FAQs)

1) What is the purpose of NIH RFA-DA-21-009?

This NIH funding opportunity supports research aimed at reducing electronic nicotine delivery system (ENDS) use among adolescents. The goal is to generate evidence that can inform prevention practice and tobacco control policy, including evidence explaining not only whether an approach works, but also why it works and under what real-world conditions it can be implemented widely.

2) What types of projects does this opportunity fund?

The announcement supports two main types of projects:

• Prevention intervention studies that test how well interventions prevent adolescents from starting ENDS use or prevent progression from experimentation to more frequent or dependent use.
• Policy-focused studies that examine how tobacco control policies, including policies written specifically for ENDS, influence adolescent vaping behavior.

3) Who is the main target population for this grant?

The core target population is adolescents ages 12 through 18.

4) Can an application focus on a narrower age range within 12 to 18?

Yes. Applicants are expected to justify the specific ages they plan to study. The opportunity notes that developmental timing, first exposure, social influences, and access can differ across middle school and high school years, so a clear rationale for focusing on early vs. late adolescence (or other narrower bands) is important.

5) Can a project include youth outside the 12 to 18 age range?

Yes, but the application is expected to provide a clear rationale for including youth outside ages 12 to 18, since the opportunity is centered on preventing initiation and escalation during adolescence.

6) What does the announcement emphasize about theory and mechanisms?

The opportunity places special emphasis on research that is grounded in theory and that clearly identifies:

• Risk factors that push adolescents toward ENDS use
• Protective factors that help keep adolescents from using ENDS

Applicants are expected to connect these factors directly to the intervention targets (for prevention interventions) or the policy mechanisms being studied (for policy research).

7) What settings are highlighted for prevention intervention studies?

For intervention-focused applications, the announcement highlights real-world prevention approaches in settings where adolescents can be reached at scale, such as:

• Schools
• Communities
• Clinics

8) Is collaboration with stakeholders required for intervention-focused applications?

Yes. The opportunity describes collaboration with stakeholders and likely adopters as a requirement, not an optional add-on. The intent is to ensure the intervention is feasible to implement, scalable beyond study sites, disseminable, and has a realistic path to sustainability after grant funding ends.

9) Who counts as a stakeholder or likely adopter for collaboration purposes?

Examples listed in the opportunity include organizations and decision-makers who would be responsible for using the intervention after the study, such as:

• School districts
• Youth-serving community organizations
• Healthcare systems
• Public health departments
• Other relevant decision-makers

10) What NIH funding mechanism is used for this opportunity?

The mechanism is an NIH R01 research project grant.

11) Are clinical trials required?

No. Clinical trials are optional. Applicants may propose clinical trial designs or other rigorous study designs, depending on what best fits the research questions.

12) What kind of evidence is NIH trying to generate through this program?

The program aims to generate evidence that informs both prevention practice and policy, including evidence that helps explain:

• Whether an intervention or policy approach works
• Why it works
• Under what conditions it can be implemented widely

13) What types of organizations are eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations, including:

• State, county, city, township, and special district governments
• Independent school districts
• Public and state-controlled institutions of higher education
• Private institutions of higher education
• Federally recognized tribal governments
• Tribal organizations that are not federally recognized
• Public housing authorities/Indian housing authorities
• Nonprofits with or without 501(c)(3) status (outside of higher education)
• For-profit organizations other than small businesses
• Small businesses

14) Are any additional applicant categories explicitly called out as eligible?

Yes. The opportunity explicitly calls out additional eligible applicant categories such as:

• Alaska Native and Native Hawaiian Serving Institutions
• AANAPISI institutions
• Hispanic-serving institutions
• HBCUs
• Tribally controlled colleges and universities
• Faith-based or community-based organizations
• Regional organizations
• Eligible federal agencies
• U.S. territories or possessions

15) Can foreign organizations apply directly?

No. The opportunity states that non-U.S. entities (foreign organizations and foreign institutions) cannot apply directly.

16) Are non-U.S. components of U.S. organizations eligible?

No. The opportunity states that non-U.S. components of U.S. organizations are not eligible.

17) Are any foreign components allowed at all?

Yes, foreign components are permitted when they meet the NIH definition in the NIH Grants Policy Statement. This means the applicant organization must be domestic, but certain international elements of a project may be allowed under NIH rules.

18) Which NIH agency is sponsoring this opportunity?

The opportunity is listed as a discretionary grant from the National Institutes of Health (NIH).

19) What activity areas does this grant opportunity cover?

The listed activity areas span health and education.

20) What CFDA numbers are associated with this opportunity?

The opportunity lists CFDA numbers 93.279 and 93.399.

21) What are the key dates provided in the source record?

The source record lists:

• Posting creation date: June 16, 2020
• Original closing date: October 19, 2020

22) Does the provided record specify the award ceiling or number of awards?

No. The provided fields do not include an award ceiling or the expected number of awards. The record indicates applicants would typically confirm budget expectations and related details through the full FOA text and any institute guidance.

23) What is the overall expectation for intervention scalability and sustainability?

For intervention-focused projects, the announcement emphasizes that partnership with likely adopters is meant to support:

• Feasibility of implementation in real-world settings
• Scaling beyond the study sites
• Effective dissemination
• A realistic path to sustainability after grant funding ends

24) What outcomes or behaviors are intervention studies expected to address?

Intervention studies are expected to test prevention approaches that stop adolescents from initiating ENDS use and/or prevent escalation from experimentation to more frequent use or nicotine dependence.

25) What is the focus of policy research under this opportunity?

Policy research is intended to examine how tobacco control policies, including ENDS-specific policies, influence adolescent vaping behavior, with emphasis on connecting policy mechanisms to relevant risk and protective factors.