The National Cancer Institute (NCI) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Coronavirus Disease 2019 (COVID-19) and the effects of its causative agent, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on cancer, and vice versa. Topics of specific interest to NCI include understanding 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.

Background
The COVID-19 pandemic is an urgent health emergency (as defined by CDC and WHO). Persons diagnosed with COVID-19 have reported symptoms such as fever, cough, shortness of breath, fatigue, myalgias, headache, sore throat, abdominal pain, and diarrhea. Patients admitted to the hospital generally have pneumonia and abnormal chest imaging. Complications include acute respiratory failure and acute respiratory distress syndrome, which appears to be a significant predictor of mortality. The severity of illness and course of the infection is heterogeneous and appears to be more severe in the elderly and in individuals with underlying comorbidities including cancer. Due to the presence of malignancy and the effects of anticancer treatments, cancer patients often exist in a systemic immunosuppressive state and are more susceptible to many types of infection. Therefore, these patients might be at an increased risk of COVID-19 and have a poorer prognosis. To date, SARS-CoV-2 infection and COVID-19 have not significantly impacted children, a pattern atypical for most viral respiratory diseases.

Research Objectives
To better understand the impact of SARS-CoV-2 infection and its impact on cancer patients disease progression, response to therapy, care delivery, or survivorship, the NCI encourages the submission of applications to either PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement Clinical Trial Optional) or to PA-18-591, Administrative Supplements to Existing Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). Of particular interest are studies that take advantage of unique cancer model systems or analytical tools to study the consequences of SARS-CoV-2 infection and COVID-19 disease progression. Supported research is expected to inform future efforts to diagnose, prevent, mitigate, or treat this viral infection in persons with cancer (or pre-cancer), undergoing treatment for cancer, or are in remission.

Possible research interests include, but are not limited to, the following areas focused on the intersection of cancer research and infection with SARS-CoV-2 or illness associated with COVID-19 disease:

• Fundamental biological processes related to cancer such as cell growth, transformation, invasion, and metastasis that are affected by SARS-CoV-2 infection or COVID-19 disease;
• Fundamental biological processes related to SARS-CoV-2 virology and infection, especially how it is affected by cancer cells;
• Population-level determinants of occurrence and outcomes in cancer patients with SARS-CoV-2 infection or COVID-19 disease;
• Impact on cancer related care delivery due to the COVID-19 pandemic;
• The impact of infection with SARS-CoV-2 on cancer prevention, early detection, screening, diagnosis, and treatment planning;
• Assessment of COVID-19 disease on the efficacy of anticancer agents, radiation treatments, surgical methods, and all other cancer treatment modalities;
• Repurposing of cancer therapeutics for treatment of patients with COVID-19 disease;
• Potential for differential responses among diverse cancer patient populations to SARS-CoV-2 infection or COVID-19 disease.

Applications may request funds for the collection of samples from human cancer cohorts of individuals with COVID-19 disease or evidence of SARS-CoV-2 infection, and/or development of novel cancer model systems to expose animals and cells to SARS-CoV-2.

Applicants are strongly encouraged to contact the NCI Program Director of the parent award to discuss potential applications and whether urgent competitive revision applications or administrative supplement requests are more appropriate for the proposed research.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following target funding opportunity announcement or subsequent reissued equivalent.

• PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)
• PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Administrative supplements proposed through PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) must be within the general scope of the research or training that is already supported. Eligible activity codes for applications to PA-18-591 are limited to the mechanisms listed in PA-18-591.

Eligible activity codes for applications proposed through PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements Clinical Trial Optional) are limited to the following mechanisms: P01; P30; P50; R00; R01; R33; R35; R37; U01; U19; U24; and U54.

To be eligible for an Urgent Competitive Revision or an Administrative Supplement through this NOSI and the respective FOA, the parent award on which the revision application is based must:

• be an active NCI award (i.e., not be in an extension period) at the time the revision/supplement is awarded
• have sufficient time (i.e., 1 year) left to complete the studies proposed after the revision/supplement has been awarded within the existing project period (including a planned no-cost extension).

All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-18-935 or PA-18-591) 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.
• Application budgets are limited to no more than $100,000 in direct costs per year.
• Applications will be accepted on a rolling basis from April 14, 2020, through June 25, 2020, by 5:00 PM local time of the applicant organization. This NOSI expires on June 26, 2020.
• IMPORTANT: For funding consideration, all applicants must designate "NOT-CA-20-042" (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.
• 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
  • Urgent competitive revision applications through this NOSI to PA-18-935 must use the application form package with the Competition ID of NOT-CA-20-042-FORMS-E." This FOA will be reissued with a NOT-CA-20-042-FORMS-F package on May 25, 2020. Submissions to PA-18-935 must be completed by June 25, 2020 (see NOT-OD-20-026 for details). Submissions to the reissued FOA will be accepted on or after May 25, 2020, through the expiration date of this Notice.
  • Administrative supplement applications through this NOSI to PA-18-591 must use the application form package with the Competition ID of FORMS-E-ADMINSUPP-RESEARCH". This FOA will be reissued with a FORMS-F-ADMINSUPP-RESEARCH package on May 25, 2020. Submissions to PA-18-591 must be completed by June 25, 2020 (see NOT-OD-20-026 for details). Submissions to the reissued FOA will be accepted on or after May 25, 2020, through the expiration date of this Notice. The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applications should include a data sharing plan and should state if the application falls under the NIH Genomic Data Sharing Policy.
• 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 NCI Program Directors of the parent award before writing and submitting their competitive revision and/or administrative supplement applications to allow for the determination of appropriateness and interest of the NCI in any related proposed research.