Updates on NIH Flexibilities and Funding Opportunities for COVID-19

 

Dear CFAR community,

As you are well aware, things are changing daily as a result of this unprecedented COVID-19 pandemic. The purpose of this email is to provide you an update on the changes at NIH. All changes from our previous communication from March 20th are noted in red.

Please continue to let us know how we – as the UCSF-Gladstone CFAR – can assist you in your research during this crisis. We still plan to assemble templates of letters for late applications, delayed progress reports, etc. and can help in further exploring grant opportunities for you. We are meeting with the early stage investigators via Zoom once weekly to answer any clinical questions regarding COVID-19 or questions regarding research opportunities. This pandemic will lead to a multitude of new research questions and the UCSF-Gladstone CFAR will continue to help you and your research programs moving forward.

Thank you for everything you are all doing for the COVID-19 response. We know this is a hard time, and we are here to support you. Please feel free to reach out to any of us if there’s anything we can do to help.

Sincerely,
Monica, Peter, Mallory, and Lauren


Part 1: NIH Flexibilities for Applicants and Awardees
NIH has announced flexibilities for applicants and recipients affected by COVID-19 as well as accompanying FAQs and this helpful YouTube video. Documentation and communication with NIH are key, as research is slowed, impacted, or changes due to the emergency.

Impacts on Training, Fellowship and Career Development Awards and ESI Status (In the FAQ)
The FAQ lists several areas where flexibilities can be requested due to COVID-19 impacts:

  • Phased Awards: NIH will allow extensions on phased awards (e.g., K22, K99/R00) where applicants are unable to transition to a faculty position.
  • Extension of ESI Status: Investigators can request extension of ESI status through eRA Commons if they have been affected by COVID-19 university closures or other impacts.
  • Extensions of T32 or other fellowships: Recipients may submit extension requests to funding ICs. Requests must include a description of how COVID affected the award, clearly outline how much additional time is needed, and must be signed by the fellow, the Organization, and the fellowship sponsor.
  • Effort level requirements: recipients are allowed to request reductions in effort below the required level due to COVID by contacting the funding IC.


Late applications (Updated: NOT-OD-20-091 - Previous: NOT-OD-20-082)
NIH will accept late applications for due dates between 3/9 and 5/1, with no advance permission or explanation needed. Due dates after May 1 (including the May 7, 2020 AIDS deadline) will remain as posted and usual late application policies will apply.

Late Progress Reports and other FAQs (NOT-OD-20-083) No changes noted from our previous email.
If grant/contract recipients are not able to submit required progress (RPPR), financial (FFR), or invention reports on time, they should let their grants management official/program officer know ASAP. NIH will accept these reports, but the next year’s award may be delayed until all required reports are submitted.
Many of the other FAQs on this page provide answers about cancelled travel or meeting reimbursement and flexibilities.

Delays in Research Progress and Unanticipated Costs (NOT-OD-20-087) No changes noted from our previous email.
Delays: NIH understands that delays may occur due to institutional measures to protect participants and research staff. They will allow mid-project period or additional extensions beyond the usually allowed 12-months for projects involving human subjects. Awardees should work with RMS to submit a justification for the extension to NIH. We are currently seeking clarification on whether time on training grants will be extended based on this unprecedented crisis.
Unanticipated Costs: If unanticipated costs are identified, and the project budget doesn’t have funds available to cover those costs, recipients are able to request administrative supplements (PA-18-591) to cover these expenses. Funding will be prioritized for requests that support the safety and welfare of participants and sustain research during any delays. More information on this will be provided in the future.

Other Flexibilities Available (NOT-OD-20-086) No changes noted from our previous email.
These flexibilities are applicable to NIH applicants and recipients where the entity is conducting research activities related to or affected by COVID-19 (this applies to all of us in the UCSF-Gladstone CFAR). Affected entities are those that have been closed or where business activities have been hindered due to COVID-19 precautionary measures and/or illnesses. Documentation is required which describes the effects along with how long facilities and NIH related research, clinical practices, or instruction was and/or will be affected.
These flexibilities include:

  • pre-award costs
  • prior approval requirement waivers
  • extensions to reporting, closeouts and single audit requirements
  • cost-related expenditures such as salaries and stipends, travel, and conference registration fees, and NIH supported meetings and conferences

The UCSF-Gladstone CFAR will continue to update this digest as more information becomes available. We encourage you to reach out to your program officer and GMS for further information. Rest assured that the NIH is well aware of the impact of this crisis on ongoing research programs. A reassuring statement from the YouTube video the NIH produced on this topic is below:
“We understand with everything else that’s going on right now, getting your application in on time is probably not going to be the first thing on your mind or the easiest thing to do. We put out a guide notice specifically on late applications; you can submit late applications, and you do not need to get pre-approval. All you need to do is submit a brief cover letter that explains why your application is late, and we will take it from there. … We want to be accommodating. We understand the difficulties that you’re dealing with, so we will do everything we possibly can to be flexible and accommodating.”

Part 2: Supplemental Funds for Research on 2019-nCoV
NIH has so far issued twenty Notices of Special Interest (NOSI) from fifteen Institutes (plus the Office of the Director and AHRQ) on supplements to current grants to add research on COVID-19. We anticipate that other NIH Institutes will also release additional NOSIs. A brief summary of the available opportunities are listed below, and a more detailed table will be kept updated here with any additions: https://cfar.ucsf.edu/covid-19-supplement-opportunities.

There are three types of supplemental funds available: 1) Urgent Competitive Revisions using PA-18-935, which expand the scope of the parent grant, 2) Emergency Competitive Revision to Existing NIH Awards using PA-20-135, which also expand the scope of the parent grant, and 3) Administrative Supplements under PA-18-591, which provide funds for work within the scope of the parent grant. Examples of a change in scope include the addition of human subjects or children to a grant that has not been previously so coded and approved, the addition of vertebrate animals to a grant that has not been previously so coded and approved, or an application that does not involve the parent project study population (e.g., people living with HIV on an HIV grant). The review for any grants involving COVID-19 will be highly streamlined.

There are key differences in topics of interest, eligible activity codes (e.g., R01, K08, R21), amount of funding available, and the period of funding (e.g. 1 or 2 years), depending on the funding mechanism and institute. All investigators interested in submitting an application under any of the below NOSI should plan to discuss their proposed research with NIH program staff ahead of submitting to make sure that the project is responsive.

1. NIAID NOT-AI-20-034 replaced NOT-AI-20-030 as of 4/8.
Mechanism: Competitive revisions using *PA-20-135* to current NIAID grants. Administrative supplements under PA-18-951 now covered in NOT-AI-20-031 below.
Eligible activity codes: No listed activity code restrictions.
Topics of interest: Viral natural history, pathogenicity, transmission, as well as projects developing medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against 2019-nCoV.
Period: up to 2 years (parent award must be active when revision submitted and an exception must be granted for supplement periods outside the parent project period)
Budget: no more than the parent award, though exceptions will be considered.

2. NIGMS NOT-GM-20-025 replaced NOT-AI-20-030 as of 4/8.
Mechanism: Competitive revisions using PA-18-935 to current grants
Eligible activity codes: No listed activity code or IC restrictions (confirm with program officer).
Topics of interest: Incorporation of data from the 2019-nCoV into ongoing research efforts to develop predictive models for the spread of Coronaviruses and related pathogens.
Period: not exceeding one year. Parent project must be active when application is submitted.
Budget: no more than the parent award, unless an R15, R21, or R00 grant

3. NHLBI: NOT-HL-20-757
Mechanism: competitive revisions under PA-18-935 and administrative supplements under under PA-18-591 to active NHLBI-funded or co-funded awards only.
Eligible activity codes: Competitive Revision: Only P01, R00, R01, R03, R15, R21, R33, R35, R41, R42, R43, R44, R61, U01, U24, U54, UG3, UH3, UM1; Administrative supplement: Most active NHLBI-awarded or co-funded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: COVID-19 and on biological effects of SARS-CoV-2, including host response, associations with heart, lung, and blood (HLB) diseases, potential impacts on transfusion safety, and clinical outcomes of infected individuals.
Period: Generally limited to 1 year. Up to 2 years with strong justification.
Budget: No more than parent award
See new FAQs here.

4. NIDA: NOT-DA-20-047
Mechanism: competitive revisions under PA-18-935 and administrative supplements under under PA-18-591. Applications can come from any funding IC as long as the topic is NIDA-specific.
Eligible activity codes: No listed activity code restrictions.
Topics of interest: Research collecting and examining data on the risks and outcomes for COVID-19 infection in individuals suffering from substance use disorders.
Period: Up to two years. Must be within parent project period.
Budget: $100k/ year, more if cleared with NIH

5. NIA/NIMH NOT-AG-20-022
Mechanism: competitive revisions to current NIA or NIMH grants under PA-18-935 and administrative supplements under PA-18-591.
Eligible activity codes: Competitive Revision: only P01, P30, RF1, R00, R01, R03, R15, R21, R24, R25, R33, R35, R41, R42, R43, R44, R56, R61, U01, U19, U24, U54, UG3, UH3, UM1, K01, K02, K07, K08, K23, K24, K25, K76. Administrative supplement: Most active NIA or NIMH-awarded or co-funded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: NIA: Research to better understand COVID-19, particularly to improve prevention of disease transmission among older adults and mitigation of disease severity and mortality in older adults with COVID-19. NIMH: Research to examine a disrupted workforce may adequately respond/adapt to and maintain additional care for new or worsening mental health needs and/or suicide risk in midlife and older age adults.
Period: Generally limited to 1 year. Up to 2 years with strong justification.
Budget: not stated specifically. Generally limited to amount of the parent award.

6. NIMHD/NIMH/NIA NOT-MD-20-019
Mechanism: competitive revisions to current grants under PA-18-935 and administrative supplements under PA-18-591. Note IC limitations noted in topics of interest below and confirm eligibility with NIH.
Eligible activity codes: Competitive Revision: only P01, P30, RF1, R00, R01, R03, R15, R21, R24, R25, R33, R35, R41, R42, R43, R44, R56, R61, U01, U19, U24, U54, UG3, UH3, UM1, K01, K02, K07, K08, K23, K24, K25, K76. Administrative supplement: Most active NIA or NIMH-awarded or co-funded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: NIMHD: Research in health disparity populations that seeks to understand: 1) how state and local policies and initiatives mitigate or exacerbate disparities in health services use and health outcomes; 2) the role that community-level protective and resilience factors and interventions have in mitigating the effects of the sector disruptions that the COVID-19 outbreak causes; and 3) how behavioral and/or biological mechanisms may contribute to COVID-19 manifestations. NIMH: Research to examine how a disrupted workforce may adequately respond/adapt to and maintain services or provide additional care for new or worsening mental health needs where we anticipate health disparities will be most prominent will be seen as a high priority. Supplements to NIMH grants only. NIA: Research on the specific needs and circumstances of midlife and older adults, including, but not limited to, individuals with Mild Cognitive Impairment (MCI), Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) and their healthcare providers and caregivers. Supplements to NIA projects only.
Period: Generally limited to 1 year. Up to 2 years with strong justification. Must be within parent project period.
Budget: No more than $125,000 direct costs.

7. NIMH/NIA/NIAAA/NIMHD NOT-MH-20-047
Mechanism: competitive revisions to current grants under PA-18-935 and administrative supplements under PA-18-591. Note IC limitations noted in topics of interest below and confirm eligibility with NIH.
Eligible activity codes: Competitive Revision: only P01, P30, RF1, R00, R01, R03, R15, R21, R24, R25, R33, R35, R41, R42, R43, R44, R56, R61, U01, U19, U24, U54, UG3, UH3, UM1, K01, K02, K07, K08, K23, K24, K25, K76. Administrative supplement: Most active NIA or NIMH-awarded or co-funded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: NIMH: Research to strengthen the mental health response to COVID-19, especially research to provide an evidence base for how a disrupted workforce may adequately respond/adapt to and maintain services or provide additional care for new or increasing mental health needs, as well as to learn about the effects of the virus and public health measures to prevent spread of COVID-19 that may have an impact on mental health. Research addressing the intersection of COVID-19, mental health, and HIV treatment and prevention are also of interest to NIMH. NIA: Research that falls within the scope of the project above and addresses the specific needs and circumstances of midlife and older adults and their healthcare providers and caregivers. Supplements to NIA projects only). NIMHD: Research within the scope of this announcement that examines the onset and course of anxiety and depression due to social determinants of health challenges or POC screening and brief mental health assessment for populations unlikely to engage in mental health services. Supplements to NIMHD projects only. NIAAA: Research studying individuals with alcohol use disorder with and without comorbid psychiatric disorders, e.g., posttraumatic stress disorder, anxiety disorder, major depressive disorder, etc. Specific areas of interest include but are not limited to service delivery, telehealth, interactions between stress and social isolation on symptomatology, and increased risk for suicide as related to alcohol use in the general population and in under resourced communities, such as racial, ethnic and gender minorities; low socioeconomic, incarcerated, and homeless populations, etc. Supplements to NIAAA projects only.
Period: Not specified.
Budget: Not specified.

8 NIAID NOT-AI-20-031
Mechanism: New grant applications (R03: PA-19-052, R21: PA-19-053, R01: PA-19-056) and Administrative Supplements under PA-18-591.
Activity codes: R03, R21, R01 and Administrative supplements
Topics of interest: Research focusing on viral natural history, pathogenicity, transmission, as well as projects developing medical countermeasures and suitable animal models for pre-clinical testing of faccines and therapeutics against SARS-CoV-2/COVID-19.
Period: Depends on the mechanism.
Budget: Depends on the mechanism. Administrative supplement is limited to the amount of the parent supplement.

9. OD/OBSSR/NHLBI/NIA/NIAAA/NIDDK/NIEHS/NCCIH/NCI NOT-OD-20-097
Mechanism: competitive revisions to current NIA or NIMH under PA-18-935 and administrative supplements under under PA-18-591.
Eligible activity codes: Competitive Revision: only P01, P30, RF1, R00, R01, R03, R15, R21, R24, R25, R33, R35, R41, R42, R43, R44, R56, R61, U01, U19, U24, U54, UG3, UH3, UM1, K01, K02, K07, K08, K23, K24, K25, K76. Administrative supplement: Most active NIA or NIMH-awarded or co-funded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: Research on key social and behavioral questions related to the COVID-19 pandemic, including adherence to and transmission mitigation from various containment and mitigation efforts; social, behavioral, and economic impacts from these containment and mitigation efforts; and downstream health impacts resulting from these social, behavioral, and economic impacts,including differences in risk and resiliency based on gender, race and ethnicity, socioeconomic status, and other social determinants of health. To rapidly improve our understanding of the critical social and behavioral aspects of the COVID-19 pandemic, this NOSI encourages submission of applications for urgent competitive revisions or administrative supplements to active grants studying existing longitudinal cohorts, particularly those cohorts with considerable data relevant to COVID-19 social and behavioral factors prior and subsequent to the SAR-CoV-2 outbreak in various locations
Period: May not exceed two years. Must be within parent project period.
Budget: Generally limited to $100,000 direct costs, may be increased with strong justification.

10. NIDDK NOT-DK-20-020 *HIV Specific*
Mechanism: competitive revisions to current NIDDK grants under PA-18-935
Eligible activity codes: R01, RC2, P01, U2C, UH3, U01, P50, U54, R41, R42, R43, and R44
Topics of interest: Research studies to elucidate if COVID-19 might provoke or exacerbate noncommunicable gastrointestinal, liver, kidney/urological and metabolic/endocrine diseases in people with HIV (PWH) or worsen the consequences of viral hepatitis coinfection. Conversely, it is also important to elucidate whether people with HIV (PWH) with CCCs within the mission of NIDDK have different COVID-19 outcomes.
Period: Must be able to be completed in the amount of time remaining on the parent award.
Budget: Limited to the lower of the current year direct cost budget or $500,000 direct costs.

11. NIDDK NOT-DK-20-018
Mechanism: competitive revisions to current NIDDK grants under PA-18-935
Eligible activity codes: R01, RC2, P01, U2C, UH3, U01, P50, U54, R41, R42, R43, and R44
Topics of interest: Research focusing on the direct action of the virus on kidney, gastrointestinal tract function, and the endocrine/metabolic system, and the collection of biosamples that will inform the understanding of renal, gastrointestinal, and endocrine/metabolic sequelae of viral infection. Pilot clinical studies (observational and interventional) that support the understanding or treatment of COVID-19-related diseases within the mission of the NIDDK are also of interest.
Period: Must be able to be completed in the amount of time remaining on the parent award.
Budget: Limited to the lower of the current year direct cost budget or $500,000 direct costs.

12. NCI NOT-CA-20-042
Mechanism: competitive revisions to current NIA or NIMH under PA-18-935 and administrative supplements under under PA-18-591.
Eligible activity codes: Competitive Revision: only currently funded NCI grants P01; P30; P50; R00; R01; R33; R35; R37; U01; U19; U24; and U54. Administrative supplement: Most active NCI-awarded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: Research to understand the basic mechanisms of interaction between SARS-CoV-2 and cancer cells, co-morbidities of cancer and SARS-CoV-2 infection (especially in disparately affected patient populations), and the impacts on treatment and clinical outcomes of SARS-CoV-2 infected persons in the context of cancer.
Period: Generally limited to one year. Must be within parent project period (planned NCE okay).
Budget: Limited to $100,000 direct costs.

13. NIEHS NOT-ES-20-020
Mechanism: New R21 grant applications (RFA-ES-19-011) or competitive revisions under PA-18-935 and administrative supplements under PA-18-591 to current NIEHS grants.
Activity codes: R21 for new grants, No activity code restrictions listed for supplements.
Topics of interest: Research that will provide insight into the role of environmental exposures in pathogenicity, transmission, individual susceptibility, or prevention and intervention strategies.
Period: 2 years for R21. One year for supplements.
Budget: R21: up to $275k direct costs over 2 years. Limit not noted for supplements.

14. NIBIB NOT-EB-20-008
Mechanism: competitive revisions to current grants under PA-20-135 and administrative supplements under under PA-18-591.
Activity codes: Competitive revision: DP1, DP2, P41, R00, R01, R03, R15, R21, R24, R37, R41, R43, R44, R56, U01, U18, U24, U2C, U54, UG3, UH2, UH3. Administrative supplement: Most active activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32. Confirm that grants from ICs other than NIBIB are eligible.
Topics of interest: Research to accelerate the development, translation, and commercialization of technologies to address Coronavirus Disease 2019 (COVID-19).
Period: Generally limited to 1 year. Up to 2 years with strong justification. Must be within parent project period.
Budget: No more than the parent grant.

The other newly-released NOSIs are probably not of high interest to CFAR investigators, so we'll link to them very briefly here:

  • NOT-HG-20-030: Supplements for existing NHGRI grantees to perform genomic studies utilizing generalized approaches that take advantage of human research or model systems to study the consequences of SARS-CoV-2 infection
  • NOT-ES-20-017: Supplements for existing NIEHS Superfund Worker Training program grantees to provide support for the conduct of worker-based training to prevent and reduce exposure of workers at risk of exposure to Coronavirus through their work duties.
  • NOT-TR-20-011: Supplements to existing CTSI UL1, U01, and R21 projects to provide informatics solutions to diagnose cases and the use of CTSA-supported core resources (e.g., advanced scientific instruments, highly-specialized facilities, and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics, therapeutics, and vaccines.
  • NOT-TR-20-017: Supplements to existing NIH-funded grants for microphysiological systems research or the NIH Microphysiological Systems Program to conduct research in the use of microphysiological systems or tissue chips in collecting and examining data on the risks and outcomes for COVID-19 infection, and advance the translation of research findings into diagnostics, therapeutics, and vaccines.
  • NOT-HS-20-008: A notice of intent to publish an R01 funding opportunity to support novel, high-impact studies evaluating health system and healthcare professional responsiveness to COVID-19.
  • NOT-GM-20-027: Competitive Revisions to active NIGMS U24 awards to develop predictive models for the spread of SARS-CoV-2 and outcomes of possible COVID-19 public health intervention measures.

UCSF’s Office for Sponsored Research (OSR) has also compiled a list of funding opportunities related to COVID-19, which they are updating here. You should check for updates on that page. We will send out another update with non-NIH funding opportunities in the next few days.