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Answers to Questions about the Impact of COVID-19 on NCI Grants

Questions about NOT-CA-20-042

The NOT-CA-20-042 - National Cancer Institute Announcement Regarding Availability of Urgent Competitive Revisions and Administrative Supplements on Coronavirus Disease 2019 (COVID-19) includes opportunities for an Administrative Supplement (PA-18-591) and for an Urgent Competitive Revision (PA-18-935). Which announcement should I use?

  • If the research that you propose is considered “in the scope” of the parent grant, use the Administrative Supplement announcement, PA-18-591.
  • If the research that you propose is considered “out of the scope” of the parent grant, use the Competitive Revision announcement, PA-18-935.

Because virtually no NCI grantees currently have COVID-19 grants, NCI will use a broad interpretation of what is “in the scope” of the parent grant. A logical extension of the current work that adds a COVID-19 related project with cancer relevance would generally be considered “in scope.” However, some conditions that would be considered a change in scope include those that would typically require prior approval such as:

  • Introduction of a new vertebrate species (e.g., mice in parent grant and the supplement application proposes to study nonhuman primates).
  • Introduction of human subject research in the supplement when the parent grant does not already involve human subject research, or the proposed introduction of human subject research in children in the supplement application when the parent grant only involves adult human subject research, or vice versa.
  • Introduction of a clinical trial in the proposed supplement when the parent grant does not already include a clinical trial.
  • Introduction of new and/or additional risks to human subjects (e.g., change from minimal risk human subject research to more than minimal risk research) such that a new Data and Safety Monitoring Plan or a Data and Safety Monitoring Board is now required.

Questions regarding whether your proposal would be considered within the scope of your grant should be addressed to the Program Official for the grant prior to submission.

If your proposal meets one of the criteria listed immediately above or your Program Official determines that it is “out of scope” of the parent grant, you should use the competitive revision (PA-18-935) announcement. Otherwise, you should use the announcement for an administrative supplement, PA-18-591.

Since many institutions and labs are currently closed due to the COVID-19 crisis, how will NCI evaluate the feasibility of proposed projects?

Prior to funding, NCI will require a statement from the Authorized Organizational Representative (AOR) of the grant recipient that explicitly permits re-entry into closed labs/facilities or describes how the research will be conducted offsite or remotely/virtually.

Is there a limit in time or funds that can be requested in the application?

For both competitive revision and administrative supplement applications, budgets are limited to $100,000 direct costs for up to one year of support.

If the current grant is in a no-cost extension, can the institution apply for an administrative supplement/competitive revision to that grant?

No, the parent award must be active when the supplement/revision application is submitted (i.e., within the originally reviewed and approved project period). The NOSI requires that the current grant has sufficient time (at least one year) to conduct the project; however, a future planned no-cost extension can be used to meet the one-year requirement.

Is there a limit on the number of applications that can be submitted for a single grant?

No, there is no limit on the number of supplement/revision applications for a single award; however, applicants are strongly encouraged to discuss their plans with the Program Official of the parent award first.

Are the research topics listed in the NOSI the only areas of interest for NCI?

No, the list of research topics is not meant to be all inclusive, but projects must have both COVID-19/Coronavirus and cancer relevance. Applicants are strongly encouraged to discuss their proposals with the Program Official of the parent award.

Are non-NCI funded grants eligible for NCI supplemental funding under this NOSI?

No, the NCI NOSI is only available for NCI-funded grants. Investigators are encouraged to visit https://grants.nih.gov/grants/natural_disasters/corona-virus.htm to find other NIH funding opportunities that may be available and appropriate for their research.

What is the anticipated timeframe for funding decisions?

NCI anticipates making funding decisions on both competitive revisions and administrative supplements as quickly as possible. Our plan is that awards for approved supplements/revisions will be made no later than July 1, 2020.

Will all supplement/revision applications be funded?

No. Applications received in response to this NOSI will undergo an NCI internal review. Funding decisions will be made based on the science proposed, scientific priorities, overall progress of the parent grant, and availability of funds.

Must all applications be submitted electronically or can paper applications be submitted?

All applications responding to the NCI Urgent Award NOSI (CA-20-042) must be submitted electronically. Paper applications will not be accepted.

If an application submitted to PA-18-591 is deemed to be “out of scope” of the parent award, will the institution need to resubmit the same application to PA-18-935 within the open submission window?

If an application is deemed to be “out of scope” of the parent award, NCI will treat it as a competitive revision.

Has NCI received funding as part of the CARES Act or other COVID-19 appropriations to support projects submitted in response to NOT-CA-20-042?

No, NCI did not receive funding specifically for this purpose.

Questions about NOT-CA-20-043

Does NOT-CA-20-043 - National Cancer Institute Announcement regarding Availability of Competitive Revision SBIR/STTR Supplements on Coronavirus Disease 2019 (COVID-19) allow for submission of administrative supplement applications to PA 18-591?

No, NOT-CA-20-043 is only for competitive revision applications to PA-18-935.

Since many institutions and labs are currently closed due to the COVID-19 crisis, how will NCI evaluate the feasibility of proposed projects?

Prior to funding, NCI will require a statement from the Authorized Organizational Representative (AOR) of the grant recipient that explicitly permits re-entry into closed labs/facilities or describes how the research will be conducted offsite or remotely/virtually.

Is there a limit in time or funds that can be requested in the application?

The NCI SBIR program will consider applications of up to $250,000 in total costs for phase I (R43), and $1,000,000 in total costs for phase II (R44).

The NCI STTR program will consider awards of up to $250,000 in total costs for phase I (R41) and $500,000 in total costs for phase II (R42).

The project period for the competitive revision will generally be limited to one year.

If the current grant is in a no-cost extension, can the institution apply for a competitive revision to that grant?

No, the parent award must be active when the revision application is submitted (i.e., within the originally reviewed and approved project period).

What is the anticipated timeframe for funding decisions?

NCI anticipates making funding decisions on competitive revisions as quickly as possible. Our plan is that awards for approved competitive revisions will be made no later than August 1, 2020.

Must all applications be submitted electronically or can paper applications be submitted?

All applications responding to the NCI Urgent Award NOSI (CA-20-043) must be submitted electronically. Paper applications will not be accepted.

Will all revision applications be funded?

No. Applications received in response to this NOSI will undergo an NCI internal review. Funding decisions will be made based on the science proposed, scientific priorities, overall progress of the parent grant, and availability of funds. NCI did not receive special appropriations to fund these applications.

Questions about NOT-CA-20-054

If my grant/cooperative agreement has sufficient funding to shift to COVID-19 research would this be allowable?

If the proposed research is a change in the scope of the existing grant, it will require prior NCI approval. NOT-CA-20-054 - Contributing to the Global COVID-19 Crisis Response by Allowing Some NCI-supported Projects to be Redirected to COVID-19-related Research During the Crisis addresses specific situations when NCI will consider such requests.

How do I request NCI prior approval to repurpose funds in my award to conduct COVID-19 research that is a change in the original scope of the grant?

An email from the Authorized Organizational Representative (AOR) should be sent to the NCI Program Official for the current grant describing the proposed project and the proposed budget with a brief justification.

Please note: It is highly unlikely NCI will be able to provide supplemental funds in future years to replace funds repurposed for COVID-19 research.

Since many institutions and labs are currently closed due to the COVID-19 crisis, how will NCI evaluate the feasibility of proposed projects?

Prior to providing our approval, NCI will require a statement from the AOR of the grant recipient that explicitly permits re-entry into closed lab/facilities or describes how the research will be conducted offsite or online/virtually.

What is the anticipated timeframe for NCI’s response to requests to repurpose existing grant funds to conduct COVID-19 research?

NCI’s expectation is that these projects should be able to start immediately; therefore, NCI will provide a response within 7 to 10 days of receipt of the request.

If the COVID-19 research is within the scope of the parent award, does it require NCI prior approval to repurpose existing funds for that research?

If the research project is within the scope of the parent award, NCI prior approval would not be needed. However, you should contact the Program Official for the award to discuss the proposed research. In addition, progress on the COVID-19 research should be reported in the next Research Performance Progress Report (RPPR).

General Grant Questions

The NIH FAQs indicate that grants that do not fall under the Streamlined Noncompeting Application Process (SNAP) will be allowed to carry forward unobligated balances on their active grants for immediate efforts to support activities related to or affected by COVID-19. What information will NCI require in the requests for carry-forward approval?

The request should include an explanation of the source of the available balance as well as a description of how the funds will be used to support activities related to or affected by COVID-19. NCI will exercise maximum flexibility in reviewing the carry-forward requests.

Can a request for carry forward on a grant that does not fall under SNAP be submitted to NCI before the Federal Financial Report (FFR) is submitted and approved?

Yes. NCI will approve carry-forward requests based on estimated balances prior to the submission of the FFR. However, a term will be included in the award indicating that if the balance is less than estimated, the authorization for the carryover will be reduced accordingly.

How should I submit the carry-forward request to NCI?

The request can be submitted through the NIH prior approval module or sent directly to the Grants Management Specialist and Program Official for the parent grant. The request could also be included in the Research Performance Progress Report (RPPR) if the funds will not be needed before the next budget period.

What options will NCI consider for funding grants that report a large balance in the next RPPR?

NCI realizes that the impact of the COVID-19 pandemic on research grants could be significant; therefore, we will use maximum flexibility in reviewing large balances in grants. Options that we will consider in awarding non-competing continuations (Type 5s) will include:

  • Awarding the full committed level in addition to the carryover if the need for the funds will be immediate.
  • Restructuring the project to better align the funding with the research by allowing the grant to use existing balances for immediate needs and moving new commitments to future years.
  • Approving mid-project period extensions in cases where progress was significantly limited by the COVID-19 pandemic to allow the research to catch up.

The NIH FAQs indicate that NIH will also approve requests for second no-cost extensions related to COVID-19. What information will NCI require for second no-cost extensions?

Recipients should notify NCI via the prior approval module in eRA. Please include a brief justification addressing how the grant was impacted by the COVID-19 crisis, the number of months requested for the extension, and the unobligated balance on the award.

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