Frequently Asked Questions for RFA-DA-21-009:
- Do we need to submit a letter of intent?
A letter of intent is requested 30 days in advance of the application due date, but it is not required, is not binding, and does not enter into the review of a subsequent application. The information it contains allows IC staff to estimate the potential review workload and plan the review.
- Is the focus of the RFA on the development or evaluation of a prevention program, or both?
For intervention research, the RFA is interested in studies to test the efficacy or effectiveness of an intervention to prevent ENDS use among adolescents. For example, this could include testing the efficacy of a novel intervention. The FOA provides examples of areas of interest but is not limited to those provided.
- Do I need to choose NIDA or NCI when I submit my application?
Applications submitted in response to this RFA are not required to choose an IC when the application is submitted.
- What is the total amount of funds available for this FOA?
The commitment from NIDA is $1,000,000 and the commitment from NCI is $1,000,000. Co-funding from the Office of Behavioral and Social Sciences Research and the Office of Disease Prevention is TBD.
- Is there more interest in school-based interventions?
The RFA is not limited to school-based research.
- Does the proposal have to address any potential challenges that can occur due to COVID-19?
It is up to the applicant based on the work that is being proposed. If COVID-19 issues would present challenges to the research, then it may be important to address it. Raising potential challenges and describing plans for addressing them can be helpful for understanding feasibility.
- What do you suggest for addressing unknown timelines and changes in school or community openings related to COVID?
Applicants should address this as needed for what is being proposed. This FOA aligns with May Council 2021. The earliest start date for awards is July 2021.
- Explain the following--"Studies to adapt or optimize evidence-based substance use prevention approaches to prevent ENDS use are allowed but must be well justified."
Applications that propose to adapt an intervention with a prior evidence-base—such as for other substance use outcomes—for the prevention of ENDS use among adolescents should include a strong justification.
- Would biological endpoints in a clinical trial be considered important/relevant for this RFA, or are patient-reported outcome data enough?
The decision to include biological endpoints is at the discretion of the applicant, in the context of what is being proposed and what is feasible.
- Is it required that the primary outcome is ENDS use or could it be some other related outcome such as provider intervention rates or patient perceptions?
The intent of the RFA is to support research to understand impact on ENDS Use behaviors among adolescents as a primary outcome. Other outcomes may be included but understanding impact on ENDS Use behaviors is a primary focus.
- The target age range is noted as 12 - 18 years. Justification for the specific age is required, including studies that propose targeting youth outside the core age range. Would an intervention including college students age 18-24 be responsive to this call?
An application proposing a study within or outside of the core age range should include a justification for the target age range.
- Can you talk a bit more about what you are looking for from partnerships with community/school groups (stakeholder)?
Studies may or may not be situated in communities or schools. Applications may focus on other types of settings and systems. In terms of partnership or collaboration of a stakeholder, the FOA indicates interest in research that will have relevance to the setting or system that is targeted—where the intervention is likely to be adopted. The addition of a stakeholder as part of the research team is a way to integrate this perspective into the work.
- If preliminary data collection is delayed due to COVID-19, can it be added after the application is submitted?
Per NOT-OD-20-163, for applications submitted for the May 2021 Council, a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, will be accepted 30 days before the study section meeting, ONLY if the Funding Opportunity Announcement (FOA) allowed preliminary data in the application. Review NOT-OD-20-163 for specific guidance.
- Will late applications be allowed?
Per Notice NOT-DA-20-080, RFA-DA-21-009 has been modified to no longer state, “No late applications will be accepted for this Funding Opportunity Announcement.” For the October 19, 2020, application due date, the NIH Policy on Late Submission of Grant Applications - NOT-OD-15-039 applies.
- This FOA is for R01 research. Is there a possibility that other mechanisms, like the R21, would open for a similar topic?
NIDA and NCI have Notices of Special Interest and participate in FOAs that include research in this area through the R21 mechanism as well as R01 and R03 mechanisms. Visit the NIDA and NCI websites for more information on funding opportunities. Some examples are included below.
- NOT-DA-19-048 – Notice of Special Interest (NOSI): Research to Prevent Drug Use, Misuse and Addiction (July 11, 2019).
- PAR-18-848 – Electronic Nicotine Delivery Systems (ENDS): Population, Clinical and Applied Prevention Research (R21 - Clinical Trial Optional)
- PAR-18-847 – Electronic Nicotine Delivery Systems (ENDS): Population, Clinical and Applied Prevention Research (R01 - Clinical Trial Optional)
- PAR-19-309 – Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)