Frequently Asked Questions for Notice of Special Interest (NOSI): Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)
Q1. My NHLBI-funded grant is in a No Cost Extension or soon will be. Can that grant be used as the parent grant to apply to this NOSI?
A1. No, this NOSI is only open to NHLBI-funded or co-funded grants that are still in the active performance period. To be eligible for either an Administrative Supplement or Urgent Competitive Revision, the parent award on which the supplement or revision application is based must meet the following two time requirements:
- be an active NHLBI award (i.e., not be in an extension period) at the time the supplement or revision is awarded, and
- the project and budget periods must be within the currently approved project period for the parent award.
Q2. I have a grant application that has been reviewed and scored within NHLBI’s current payline, but it has not yet been awarded. Can I submit a supplement application in anticipation of the award being made?
A2. No, this NOSI is only open to grants that are in the active performance period. However, once you receive a Notice of Award you may submit a supplement application. This NOSI accepts applications on a rolling basis and is open for submissions until 5:00pm local time for applicant organization on October 5, 2020. Applications that are received October 6, 2020 or later will be withdrawn.
Q3. I don’t have any NHLBI-funded or co-funded grants, but I have a grant funded by another NIH Institute. Can I apply to this NOSI?
A3. No, but we encourage you to visit https://grants.nih.gov/grants/natural_disasters/corona-virus.htm to check on NIH funding opportunities that may be available and appropriate for your research.
Q4. My grant is co-funded by NHLBI but its primary assignment is under another Institute/Center (IC). Can that grant serve as the parent grant to apply to this NOSI?
A4. Yes, a grant co-funded by NHLBI but held by another IC is acceptable as the parent grant for this NOSI, as long as other administrative requirements are met.
Q5. Can an Investigator submit more than one supplement per the same parent grant?
A5. Yes, as long as the proposed supplement projects are distinctly different and the parent grant meets the administrative requirements, such as its funding mechanism and time remaining in the performance period, more than one supplement may be submitted on a single parent grant.
Q6. The NOSI contains opportunities for an Administrative Supplement (PA-18-591) and for an Urgent Competitive Revision (PA-18-935). Which announcement should I use?
A6. Work that is considered “in scope” of the parent grant is to use the Administrative Supplement announcement, PA-18-591.
Work that is considered “out of scope” of the parent grant should use the Competitive Revision announcement, PA-18-935.
Both mechanisms, PA-18-591 and PA-18-935, are limited to 1 year of performance unless there is strong justification for a period of up to no more than 2 years.
Because virtually no NHLBI grantees currently have a COVID-19 grant, NHLBI will have a broad interpretation of what is “in scope” of the parent grant. A logical extension of the current work that adds a COVID-19 related project 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 propose to study nonhuman primates in the supplement).
- introduction of human subjects research in the supplement when the parent grant does not already involve human subject research, or the proposed introduction of human subjects research in children in the supplement when the parent grant only involves adult human subjects research, or vice versa.
- introduction of a clinical trial in the proposed supplement when the parent grant does not already include a clinical trial, or
- introduction of new additional risks to human subjects (e.g., change from minimal risk human subjects 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.
If your proposal has one of the criteria listed immediately above, or another situation that your Program Officer determines to be “out of scope” of the parent grant, you would use the competitive revision (PA-18-935) announcement. Otherwise, you would use the announcement for an Administrative Supplement, PA-18-591.
If you have any questions about which announcement to use, you are encouraged to contact your grant Program Officer.
Q7. How many years of research performance and funding can I request under this NOSI?
A7. Both mechanisms, PA-18-591 and PA-18-935, are limited to 1 year of performance unless there is strong justification for a period of up to no more than 2 years.
Q8. How can we apply to PA-18-935 for a Competitive Revision when NHLBI is not listed as one of the participating Institutes/Centers?
A8. This is a special circumstance. Because this NOSI, NOT-HL-20-757, directs investigators to submit revision applications to PA-18-935, this effectively activates NHLBI’s participation in this announcement specifically and only for responses to this NOSI.
Q9. What are the budget caps for Administrative Supplement and Competitive Revision applications?
A9. Administrative Supplement applications submitted to PA-18-591 are limited to no more than the direct costs of the current parent award, and must reflect the actual needs of the proposed project. In other words, the direct costs per year in the supplement may not exceed the direct costs per year of the parent grant.
Competitive Revision applications submitted to PA-18-935 do not have a budget cap, but should reflect the actual needs of the proposed project. The budget requested will be a factor in consideration for funding.
Q10. My parent grant has a sizable difference in the budget from year to year. What budget year of my parent grant is considered the budget cap for my Administrative Supplement application to PA-18-591?
A10. The direct costs in your supplement application are limited to no more than the direct costs in the parent grant. For a one-year supplement application, the budget year of the parent grant in which the anticipated award date of the administrative supplement falls is the one considered the budget cap for the administrative supplement. So if the administrative supplement was anticipated to start during year 3 of the parent grant, then the budget for year 3 of the parent grant is the cap for the administrative supplement application. You may submit a supplement application with a budget of less than the budget cap, as appropriate. The budget must reflect the actual needs of the proposed project.
Applicants proposing budgets of $500,000 or more in direct costs per year are encouraged to discuss this with their parent grant Program Officer.
Q11. Will all applications received in response to the NOSI be funded?
A11. No. Applications received in response to this NOSI will undergo review. Funding decisions will be made based on the science proposed and availability of funds.
Q12. Can an investigator of an NHLBI funded HIV-focused grant submit a request for supplement funding in response to NOT-HL-20-757? If so, does the proposed research in the request have to include HIV-related work as well?
A12. Yes, the investigator of an NHLBI-funded HIV-focused grant can submit a request for supplement funding in response to NOT-HL-20-757. The proposed research in the supplement request must be aligned with the HIV/AIDS research priorities described in NOT-OD-20-018 (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html) to be funded with HIV/AIDS funds, but may be considered for NHLBI funding if a priority to NHLBI but not aligned with HIV/AIDS research priorities.
Q13. Can investigators use this Notice of Special Interest (NOSI) to fund a research supplement to an NIH/NHLBI-funded contract?
A13. No, this funding opportunity NOT-HL-20-757 is for supplements to an active NHLBI-funded or co-funded grant. However, investigators who have a qualifying grant may use resources (e.g., specimens, data, etc.) that have been generated in an NIH-funded contract in the proposed supplemental research.
Q14. What is the anticipated turnaround time for applications to be reviewed and receive funding?
A14. The process for review and funding decisions is still under development, but NHLBI will endeavor to have a funding decision to applicants within approximately 2-3 months after receipt of the application.
Q15. My institution is currently restricting access to essential services only, so my lab is closed. Can I still apply for this NOSI now or do I have to wait for my institution to allow all labs to reopen?
A15. This question is one that should be addressed with your institution. Some institutions may have exceptions that allow research on COVID-19 to proceed at this time. A Letter of Support from your institution that indicates whether COVID-19-related research (basic, translational, and/or clinical) will be allowed to proceed, and the timeframe for that, would be helpful. At a minimum, investigators should address the feasibility of conducting the proposed work in the timeframe planned in the proposal.
Q16. I have an investigational agent that I think will show efficacy in treating COVID-19 in humans. Under this NOSI can I submit a Phase I, first-in-man, clinical trial?
A16. A Phase I clinical trial proposal is allowed. However, in addition to all of the administrative requirements that must be met regarding the parent grant eligibility, several other conditions must be met before a proposed supplement/revision containing a Phase 1 trial could be considered for funding. This includes, but is not necessarily limited to: an FDA-approved IND/IDE, IRB approval, a Data and Safety Monitoring Plan or a Data and Safety Monitoring Board, and current Human Subjects Training Certification for all investigators involved in the human subjects work.