Programmatic Questions

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.

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.

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

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.

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

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

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.

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.

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

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.

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.

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.

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

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.

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

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

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

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