FAQs for Registry of Medical Cannabis Use and Health Outcomes: RFA-DA-23-011

Purpose of this FOA

The National Institute on Drug Abuse (NIDA) seeks applications to develop and maintain a medicinal cannabis use registry to assess the medical conditions reported as reasons for using medicinal cannabis, how and what products are being used, and the associated medical outcomes. The goal of this registry is to inform research, policy, and clinical recommendation practices on medicinal cannabis, associated conditions, and outcomes.

RFA-DA-23-011: Registry of Medical Cannabis Use and Health Outcomes (UM1 - Clinical Trial Optional)

Frequently Asked Questions 

  1. What is the UM1 mechanism?
    This is a cooperative agreement grant mechanism that supports a Research Project with Complex Structure. The goal is to: support cooperative agreements involving large-scale research activities with complicated structures that cannot be appropriately categorized into an available single component activity code, e.g. clinical networks, research programs or consortium. The components represent a variety of supporting functions and are not independent of each component.

    Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of the award. In practice, substantial involvement means that, after award, Federal scientific or program staff from the funding programs will assist, guide, coordinate, or participate in project activities. Under the cooperative agreement, the purpose of Federal staff is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role without assuming prime responsibility in the activities. The prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and Federal staff. Federal partners also will have access to project data and may participate in publications, if warranted. 
  2. What is the role of NIH staff in this project?
    NIH staff provide oversight, coordination, or facilitation that goes substantially beyond what would normally be needed for a R-series grant. Working jointly with U awardees, NIH staff act as partners to support and stimulate the research. However, NIH staff are not meant to play a dominant role nor assume direction or primary responsibility for awardee activities.
  3. Who will the program official and project scientist for this grant award be?
    That has not yet been determined. Dr. Kimmel, the Scientific/Research Contact, will have a significant role in the award.
  4. Is there an awardee in mind already?
    No. We have written this RFA with the overall goals of gathering data that will be informative to researchers, physicians, patients, and policymakers. No specific entity has been targeted.
  5. What is the scope of this project?
    We will give preference to projects that address medical cannabis use across multiple states rather than limiting data collection from one or a handful of states. As noted in the FAQs, the following types of projects will not be considered responsive:
    • Projects that focus exclusively on one component or one type of cannabis products (e.g. THC only or smoked cannabis only).
    • Projects that focus exclusively on adult/recreational cannabis use.
    • Projects that examine only FDA-approved cannabis medications, such as Epidiolex.
    • Project focused solely on one condition or class of conditions (e.g. chronic pain).
    • Projects focused solely on new data collection.
  6. Does the application need to include all items in the Objectives and Scope?
    No. The FOA provides information on the topics of interest to NIDA, but applicants can select from and/or expand on the objectives listed.  That said, all proposed research should be relevant to the NIDA mission and the research goals of NIDA.
  7. What components need to be included in the Research Plan?
    Subsection A is for the Registry Overview which needs to explain the overall (big picture) strategy for the proposed Registry and its components. The research strategy for the Data Coordination Center (Subsection B) and Research Program (Subsection C) need to be explained within their respective page limits (12 pages each). This results in a maximum total of 36 pages. 
  8. Is there a particular archive or platform that is required for data sharing?
    No, we have not identified a specific data archive or platform. Rather, we are requiring that these data are made available to the public. This could include datasets that are restricted to researchers with IRB and other approvals as well as datasets that are more openly available. In other words, these data cannot be reserved for the awardee's use only.
  9. The first-year budget is a maximum of $1.5 million in direct costs? What is the anticipated budget in subsequent years?
    We would anticipate budgets in the same range in subsequent years, allowing for expected increases in costs. As with any NIH funding opportunity, the proposed budget should be aligned with the research that is proposed in each year. Any subsequent year budgets that exceed the first year should be accompanied by a strong justification.
  10. Do these direct costs include indirect costs?
    No, the indirect costs are in addition to the $1.5 million in direct costs. 
  11. Are there budget limitations for the different activities listed in this RFA?
    There are no budget limitations for the various sections, so you can distribute the funds as you see fit. There are salary limits, and those are found here: 12.8.1 Salaries and Fringe Benefits and Salary Cap Summary (FY 1990 - Present).
  12. How will this be reviewed?
    This will not be reviewed at an established CSR scientific review group (SRG), but, rather by a NIDA-coordinated review group comprised of peers in this field. Darmendar Rathore is the Scientific Review Officer (SRO) for this opportunity, as noted on the RFA.
  13. How do we report a standard unit of THC?
    The May 7, 2021 NOSI NOT-DA-21-049: Notice of Information: Establishment of a Standard THC Unit to be used in Research established a standard unit of 5 mg delta-9-THC for research. As a reporting example, if someone is using 10 mg THC, that is 2 standard unit doses. For more information, see Dr. Volkow’s blog Establishing 5mg of THC as the Standard Unit for Research and the FAQs: FAQs Regarding Notice of Information: Establishment of a Standard THC Unit to be Used in Research.
  14. Will additional FAQs be added?
    Please refer back to this page frequently to check for updates to the FAQs.