Background
As of March 27, 2020, more than 565,000 cases of COVID-19 and 25,000 deaths have been reported worldwide, with more than 92,000 cases and 1,300 deaths in the United States. The severity of illness and course of the infection is heterogenous and appears to be more severe in the elderly and in individuals with underlying comorbidities. To date, SARS-CoV-2 and COVID-19 disease has not caused significant morbidity in infancy and early childhood, a pattern atypical for most viral respiratory diseases. Genomic studies can help inform efforts to prevent, diagnose and treat viral respiratory diseases.

Research Objectives
A better understanding of the host response, associated disease, and short- and long-term clinical outcomes of individuals infected with SARS-CoV-2. For NHGRI grantees only (including those with a current extension of funds or a no cost extension), we encourage the submission of applications for Competitive Revisions to support genomic research on SARS-CoV-2 and COVID-19 disease. Of particular interest are genomic studies utilizing generalized approaches that take advantage of human research or model systems to study the consequences of SARS-CoV-2 infection. Supported research is expected to guide and inform future efforts to diagnose, prevent, mitigate, or treat this viral infection.

Possible research interests include but are not limited to the following:

• Develop novel methods using genomic techniques to identify signatures of infection, prognosis, and/or severity of disease in a medical setting.
• Development of novel genomic-based tools, kits or reagents to track and monitor SARS-CoV-2 itself and infected individuals.
• Computational approaches to integrate human or animal model genomic data with data from SARS-CoV-2 infection, replication, pathogenesis and transmission to inform models of host-pathogen interactions and predict infection outcomes.
• Development of visualization, curation and analysis platforms for human and animal model genomic data related to SARS-CoV-2 infection, replication, pathogenesis and transmission studies.
• Use of electronic health information, or other relevant clinical, environmental, demographic and social determinants of health data, and accompanying genomic data to aid in tracking and understanding the genetic epidemiology of SARS-CoV-2, and the individual susceptibility and resistance to infection and disease severity.
• Studies addressing the ethical, legal and social implications of the use of genetic and genomic information and technologies to diagnose, track, monitor, treat and triage SARS-CoV-2 and COVID-19 infected patients and populations in clinical and public health settings.

Funds may be used for the collection of samples from human cohorts of individuals with COVID-19 symptoms or evidence of SARS-CoV-2 infection or controls, and/or development of novel model systems to expose animals and cells to SARS-CoV-2.

Application and Submission Information

Applications in response to this NOSI must be submitted using one of the following target opportunities or subsequently reissued equivalents.

• PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
• PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) is intended to provide funds for NIH grantees where the work proposed in the supplement is fully within the scope of the ongoing grant.
• The funding instrument, or activity code, will be the same as the parent award.
• The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.

All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-18-591 or PA-18-935) must be followed, with the following additions:

• The Research Strategy section of the application is limited to 6 pages.
• The project period will generally be limited to 1 year. Project periods of up to 2 years will be considered only with strong justification.
• Application budgets are limited to no more than $250,000 per year in direct costs and must reflect the actual needs of the proposed project. Written requests for permission to exceed the $250,000 direct costs yearly cap for particularly meritorious work must be received by April 22, 2020 by two of the scientific contacts listed below. These requests for permission to exceed $250,000 are limited to the amount of the current HG award and must include:
  • Name of PI
  • Title of Project
  • Name of Institution
  • Anticipated submission date
  • One page about the proposed project, including:
    • Goals and specific aims
    • Summary of the project’s significance, innovation, and generalizability
    • Summary of the approaches to be used

• No more than one page budget justification including direct and total costs

If approved, the document acknowledging that NHGRI will accept this greater than 250,000 in direct costs per year application should be submitted in a cover letter along with the application.

• Applications will be accepted on a rolling basis from April 1 through May 15, 2020 by 5:00 PM local time of the applicant organization. This NOSI expires on May 16, 2020. An application submitted in response to this NOSI that is received on May 16, 2020 or later will be withdrawn.
• Specific to applications that target PA-18-591 (Administrative Supplements): The process for Streamlined Submissions using the eRA Commons cannot be used for PA-18-591.
• IMPORTANT: For funding consideration, all applicants must designate NOT-HG-20-030 in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative.
• Applications nonresponsive to the terms of this Notice will not be considered for this initiative.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package using the application form package with the Competition ID of FORMS-E-ADMINSUPP-RESEARCH" for PA-18-591 and "NOT-HG-20-030-FORMS-E" for PA-18-935.
• Applications must specifically address issues of potential biohazards, and all research must be conducted in compliance with the health and safety requirements found in the NIH Grants Policy Statement.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this NOSI well in advance of the grant receipt date to better determine appropriateness and interest of the NHGRI.