NIGMS is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on SARS-CoV-2 and Coronavirus Disease 2019 (COVID-19).

Background

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, Hubei Province, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. Many other aspects of viral pathogenesis, natural history, and host range are poorly understood. Given this, there is an urgent public health need to better understand SARS-CoV-2, particularly to improve the predictive quality of existing models of spread, diagnostics for measurement of transmission, susceptibility and recovery, and development of therapeutic interventions.

Research Objectives

NIGMS will accept the submission of applications for Competitive Revisions to active grants to address only the following research areas of interest:

• Incorporation of data related to SARS-CoV-2 into ongoing research efforts to develop predictive models for the spread of SARS-CoV-2 and other related infectious agents (all relevant grants).

• Repurposing or modification of diagnostic tools currently under development to enable rapid detection of SARS-CoV-2 infection (SBIR/STTR grants only).

• Rapid development of potential therapeutic agents for COVID-19 (SBIR/STTR only).

Applications that are not responsive to the above research areas of interest will be withdrawn without review.

Application and Submission Information

Applications in response to this NOSI must be submitted to PA-18-935 "Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)", which is intended to provide funds for NIH grantees applying to expand the scope of their active grant. The activity code will be the same as that of the parent award.

Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-GM-20-025-FORMS-E." This FOA will be reissued with a NOT-GM-20-025-FORMS-F package on May 25, 2020. Submissions to PA-18-935 must be completed by June 25, 2020. Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice.

Applications will be accepted on a rolling basis from March 25, 2020 to February 5, 2021 by 5:00 PM local time of the applicant organization. This NOSI expires on February 6, 2021 . An application submitted in response to this NOSI that is received on/after the expiration date will be withdrawn.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-18-935 must be followed, with the following additions:

• For funding consideration, all applicants must designate NOT-GM-20-025 (without quotation marks) 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.
• The Research Strategy section of the application is limited to 6 pages.
• The award project period of the Competitive Revision must not exceed one year.
• Application budgets are limited to no more than the amount of the current parent award, and must reflect the actual needs of the proposed project.
• Competitive revisions to the R15, R21, and R00 may provide support above the established dollar limits for the parent grant award.
• The parent award must be active when the application is submitted.

Review Process

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIGMS staff, in accordance with the review criteria specified in the FOA as well as these additional review criteria:

• Urgency and significance of research: How will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 infection and related pathogenic processes? Does the proposed research fit within the mission of an urgent response to provide critical expertise, resources or activities?
• Feasibility of research: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the urgent time frame feasible for the proposed research? Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact the relevant program officer listed below to discuss the proposed project in the context of the parent award