Frequently Asked Questions for Notice of Special Interest (NOSI): Notice of Special Interest (NOSI): Availability of Administrative Supplements for Research on Pathobiological Mechanisms of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Q1. My NIH-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 NIH-funded or grants that are still in the active performance period. To be eligible for an Administrative Supplement, the parent award on which the supplement is based must meet the following two time requirements:

• be an active NIH award (i.e., not be in an extension period) at the time the supplement is awarded, and
• the project and budget periods must be within the currently approved project period for the parent award (see Q6).

Q2. I have a grant application that has been reviewed and scored within an NIH Institute’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 until 5:00pm local time for applicant organization on January 24, 2022. Applications that are received after that time will not be eligible for funding through this NOSI.

Q3. Can an Investigator submit more than one supplement application per the same parent grant?

A3. Yes, as long as the proposed supplement projects are distinct, and the parent grant meets the administrative requirements. However, it is expected the funding of applications to this NOSI will be highly competitive.

Q4. The NOSI contains opportunities for an Administrative Supplement (PA-20-272).what are the basic requirements for submission under PA-20-272?

A4. The proposed work for the administrative supplement must be within scope of the peer reviewed and approved project supported by the parent grant. The program officer assigned to the parent grant will make the initial determination if the administrative supplement request is within scope of the parent grant. Depending on the scope of the parent project, it may not need a SARS-CoV-2, COVID-19, or PASC component to submit an administrative supplement request to this NOSI.

• The NIH always considers the following activities to be out of scope: Introduction of a new vertebrate species (e.g., the parent grant uses mice only while the supplement request proposes to use nonhuman primates).
• Introduction of human subjects research in the supplement request when the parent grant does not already involve human subject research.

If you have any questions about scope, you are encouraged to contact the Program Officer for your parent grant.

Q5. How many years of research performance and funding can I request under this NOSI?

A5. Projects are limited to one year of performance unless there is strong justification for a period of up to no more than two years.

Q6. What are the budget caps for Administrative Supplement applications?

A6. The application budget is not expected to exceed a maximum direct cost of $750,000 per year. Supplement applications for COVID-19 research may request budgets that exceed the parent award. The proposed budget must be reasonable and reflect the actual needs of the proposed project.

Q7. 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-20-272?

A7. The application budget is not expected to exceed a maximum direct cost of $750,000 per year, regardless of the budget differences in the parent grant from year to year.  You may submit a supplement application with a budget of less than the budget cap of your parent award. The budget must reflect the actual needs of the proposed project.

Q8. Will all applications received in response to the NOSI be funded?

A8. It is expected that this NOSI will be highly competitive. The NIH anticipates funding up to 25 awards.

Q9. Can an investigator of an NIH funded HIV-focused grant submit a request for supplement funding in response to NOT-OD-22-038? If so, does the proposed research in the request have to include HIV-related work as well?

A9. Yes, the investigator of an NIH-funded HIV-focused grant can submit a request for supplement funding in response to NOT-OD-22-038. If not funded under this NOSI, this supplement may be considered for funding with HIV/AIDS funds at the parent award Institute only if the proposed research in the supplement request is aligned with the HIV/AIDS research priorities described in NOT-OD-20-018.

Q10. Can investigators use this Notice of Special Interest (NOSI) to apply for a research supplement to an NIH contract?

A10. No, this funding opportunity is for administrative supplements to an active NIH-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.

Q11. What is the anticipated turnaround time for applications to be reviewed and receive funding?

A11. The process for review and funding decisions is still under development, but NIH will endeavor to have a funding decision to applicants within approximately 2 months after the January 24, 2022 receipt date.

Q12. My institution is currently under COVID-related restrictions to staffing and access, so my lab is not fully open. Can I still apply for this NOSI now or do I have to wait for my institution to allow all labs to fully reopen?

A12. 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 will be allowed to proceed, and the timeframe for that, would be helpful.

Q13. 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-human, clinical trial?

A13. No. This is an example of work that would not be responsive to this NOSI. The objective of this NOSI is to understand biological mechanisms underlying the pathogenesis of PASC (including viral-host interactions that result in PASC) and encourages mechanistic studies and models development. This NOSI does not intend to support studies investigating agents used to treat acute infection or COVID-19.

Q14. Can I apply for research using large animal models?

A14. Yes, if these animal models were previously allowed in the parent grant (see Q4). If proposing the use or development of an NHP model, include information on animal availability (as NHP resources are limited) and justify the selection of species and animal source. Some NHP species have greater availability than others. If proposing to use NHPs from an ORIP-supported resource, please review NIH’s Updated Notice of Limited Availability of Research Non-Human Primates (NOT-OD-21-080). 

Q15. The NOSI encourages applications from at least one PD/PI whose primary expertise is in SARS-CoV-2 science. Can you provide examples which would qualify?

A15. Applicants are not required to have a NIH funded grant that focuses on SARS-CoV-2/COVID-19 to be eligible for this NOSI. As funding of applications to this NOSI will be highly competitive, applicants who can demonstrate expertise in one or more of these areas are encouraged to apply:

• PD/PI holds a current or previously funded grant either at NIH or other resource in SARS-CoV-2/COVID-19 related research.
• PD/PI is a previous recipient of an NIH-funded Administrative Supplement or Competitive Revision in SARS-CoV-2/COVID-19 related research.
• PD/PI is lead author on peer review publications in SARS-CoV-2/COVID-19 related research.

Q16. I have an active R21 that supports COVID-related research, am I eligible for this NOSI?

A16. No, for the purpose of this NOSI, eligible activity codes for applications are limited to the following NIH mechanisms: U01, U19, R01, P01, R33, R61/R33, UG3/UH3.

Q17. I have a current FDA grant funded for COVID-related research, am eligible for this NOSI?

A17. No, this NOSI is not accepting interdepartmental applications. Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent, PA-20-272, as NOT-OD-22-038 is an administrative supplement program available to those holding a current NIH grant mechanism.

Q18. I am an investigator from one of the RECOVER Research Sites, but I do not have a current NIH grant, am I eligible?

A18. No, this funding opportunity is only open to investigators with an active NIH grant (see Q17) with an eligible activity code (see Q16). RECOVER investigators are encouraged to visit https://recovercovid.org/funding for future opportunities for which they may qualify.

Q19. If I have questions about this NOSI, who should I contact?

A19. Before submitting a supplement request, applicants are strongly encouraged to contact their program officer at the Institute or Center (IC) supporting the parent award with any questions and to discuss whether the proposed supplement is within the scope of the parent award. If there are general questions regarding the content of this Notice, that cannot be answered by your program officer, please send questions to the RECOVER Initiative mailbox.