Programmatic Questions

1. Will all applications be assigned to the National Center for Complementary and Integrative Health (NCCIH)?

All applications will be assigned to NCCIH initially because they will go to the same review panel. However, after review, applications that are considered for NIH HEAL Initiative funding will be transferred to the NIH Institute or Center with a mission that aligns with the research proposed.

2. Should I contact NIH program staff before I apply?

Applicants are strongly encouraged to contact a program director at the Institute or Center that has a mission that aligns best with your proposal. It is always a good idea to speak with a program director to inquire about the level of interest at the Institute or Center where your application seems a best fit. See the scientific/research contact list in the FOA.

3. Should applicants identify which NIH Institute or Center they want to receive their application if the proposal passes the first review and scores well?

You may do this, and it would be helpful for NIH to have this information.

4. Is a letter of intent required?

A letter of intent is desired but not required. Letters of intent are helpful for NIH staff, as they allow for better management of the workload involved in reviewing applications. They also help program staff ensure your application will be responsive to the FOA. Letters of intent should be sent to Martina Schmidt at SchmidMa@mail.nih.gov.

5. Can foreign institutions submit proposals?

No, all applicant institutions and study sites must be domestic.

6. Are foreign components as defined in the NIH Grants Policy Statement allowed?

No, foreign components as defined in the NIH Grants Policy Statement are not allowed.

7. Will awardees through this FOA collaborate with those from other NIH HEAL Initiative projects?

Yes, we expect that investigators who perform clinical trials will work collaboratively through a consortium within the ERN and across other NIH HEAL Initiative clinical trial networks to standardize data elements, pain assessments, and study endpoints and outcomes as appropriate. Data from all NIH HEAL Initiative clinical trials will be stored in a central repository.

8. Can NIH intramural investigators apply to this FOA or participate in the study as co-investigators?

Yes, although requests by NIH intramural scientists will be limited to the incremental costs required for participation. These costs may include salary for staff specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Participation should be approved by the scientific or clinical director of the relevant Institute or Center.

9. Can I be a principal investigator on an application for one FOA and also be a principal investigator or multi–principal investigator on an application submitted for another FOA?

Yes, however, participation as a principal investigator is limited by your available percentage of level of effort.

10. What are the plans for data and resource sharing for this program?

Through the NIH HEAL Initiative Public Access and Data Sharing Policy, NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate on sharing their collective data and knowledge about opioid misuse and pain to provide scientific solutions to the opioid crisis. See the NIH HEAL Initiative Public Access and Data Sharing webpage (heal.nih.gov/data/public-access-data) for more information.

11. What must my application contain to be considered responsive?

Applicants must describe their research plans, including a timeline, detailed qualitative milestones, and a data sharing plan. Applicants should include their qualifications and should describe how the project will be managed. Please be sure to read the FOA thoroughly to ensure that all points have been addressed. In addition, applicants should be sure to address all the key points specific to this FOA to be responsive. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and for responsiveness by program staff of the NIH-wide working group.

12. I am a pain researcher who is not doing clinical research and would be interested in being a part of a larger group of principal investigators on an application, could you facilitate making these connections?

NIH staff unfortunately cannot facilitate connections among applicants, because applicant information is confidential. However, principal investigators are welcome to network to find other researchers interested in collaboration. In addition, principal investigators may consider contacting their local CTSA site and conducting PubMed or NIH RePORTER searches to find other researchers with relevant expertise.

13. Do you have some idea how many awards will be made through this FOA?

Funds are available for approximately three awards through this FOA and the companion FOA, RFA-AT-22-004, in fiscal year 2022.

14. For the budget, is the dollar amount listed on the FOA direct only, or direct plus indirect?

The budget listed on the FOA refers to direct costs. Please note that the planning year will have a lower budget than the other years. If the milestones from the planning year are met and the project is approved to move forward, the award will transition to the second stage of funding to conduct the trial.

15. Do applicants to this FOA need to complete the human subjects and biohazard sections?

Yes, if the applicant proposes use of human subjects and biohazards. Delayed-onset clinical trials are not acceptable.

16. Will the continuous submission extension of 2 weeks be allowed to investigators?

This FOA does not allow for continuous submissions. The deadline for all applications is December 15, 2021.

17. When do I need to apply?

Applications are due on December 15, 2021. Letters of intent are due 30 days before the application due date.

18. Whom should I contact with general questions about the FOA?

Wendy Weber, N.D., Ph.D., M.P.H.

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301-402-1272

Email: weberwj@mail.nih.gov