Emergency Competitive Revisions for COVID-19 Research

Emergency Competitive Revisions for COVID-19 Research is sponsored by NIH Office of Strategic Coordination. Emergency Competitive Revisions for COVID-19 Research is a grant from the NIH Office of Strategic Coordination that funded competitive supplemental revisions to existing NIH grants, enabling researchers to pivot their work toward urgent SARS-CoV-2 and COVID-19 research questions.

Expired NOT-RM-20-015: Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) This notice has expired. Check the NIH Guide for active opportunities and notices.

Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) Release Date: April 27, 2020 First Available Due Date: April 15, 2020 Expiration Date: June 20, 2020 PA-20-135 Emergency Competitive Revision to Existing NIH Grants and Cooperative Agreements (Emergency Supplement - Clinical Trial Optional) NOT-RM-20-016 Notice of the Common Fund’s Participation in PA-20-135 "Emergency Competitive Revision to Existing NIH Grants and Cooperative Agreements (Emergency Supplement - Clinical Trial Optional)” Office of Strategic Coordination ( Common Fund ) The Office of Strategic Coordination (OSC), which manages the Common Fund, is issuing this Notice of Special Interest (NOSI) to stimulate innovative research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the disease it causes, Coronavirus Disease 2019 (COVID-19).

OSC seeks new, innovative perspectives and approaches to the prevention of, preparation for, or response to coronavirus SARS-CoV-2, domestically or internationally. The funding for this supplement is provided from the Coronavirus Aid, Relief, and Economic Security (CARES) Act, 2020.

OSC is therefore offering Emergency Competitive Revisions to active Common Fund grants and cooperative agreements addressing the research objectives described below. The present COVID-19 pandemic necessitates a rapid response to understand the transmission, pathology, and morbidity of SARS-CoV-2 infection informed by basic biological studies to clinical research.

The Common Fund supports innovative research projects covering the full spectrum of biomedical research to shift established scientific paradigms, advance technologies, and generate impactful discoveries. OSC plans to leverage its existing projects to rapidly provide greater insights into COVID-19 with the goal of addressing the current national emergency.

In order to rapidly improve the understanding, diagnosis, and treatment of COVID-19, OSC is encouraging the submission of innovative applications for Emergency Competitive Revisions to active Common Fund grants and cooperative agreements. Innovation may be technological or conceptual.

Any relevant area of innovative research is welcome, including behavioral/social science research, research on health disparities, novel therapeutics, and other related topics. Eligible activity codes for applications to PA-20-135 are limited to the following mechanisms: D43, DP2, DP5, DP7, R01, R24, R25, R35, U01, U18, U19, U24, U2C, U2R, U42, U54, UG3, UH2, UH3 , and UM1. Other transaction awards are not eligible.

Application and Submission Information A pre-application information session teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this NOSI. Time, date, and dial in information for the call will be announced in an NIH Guide Notice and will be posted on the Common Fund website: https://commonfund.

nih. gov/covid19 . Applications in response to this NOSI must be submitted using the following targeted funding opportunity: PA-20-135 Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional), which is intended to provide funds for NIH grantees applying to expand the scope of their active grant.

The funding instrument, or activity code, will be the same as the parent award. Recipients may apply for work that is related to your funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in a no-cost extension are eligible to apply.

Please note: NOT-RM-20-015 is specific for PA-20-135 . NIH grantees seeking additional funds for research responsive to the SARS-CoV-2/COVID-19 outbreak that falls within the scope of an ongoing grant should instead apply for an administrative supplement under NIH PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements FOA ( https://grants. nih.

gov/grants/guide/pa-files/PA-18-591. html ). All applications must be submitted electronically, including those for complex awards.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-20-135 must be followed, with the following additions: Application Due Dates Applications will be accepted on a rolling basis from April 15, 2020 through June 19, 2020, by 5:00 PM local time of applicant organization. Requests may be for one year of support only.

The Research Strategy section of the application is limited to 6 pages. A Data Sharing Plan must be included and must describe how the investigators will: Rapidly share data and relevant metadata in a format and through a structure that will allow them to be findable and accessible to others. Support efforts to ensure harmonization of collected covariates and outcomes using existing standard ontologies supported by NIH/NLM.

Align and share with national and international COVID-19 related genomics initiatives such as the COVID-19 Host Genetics Initiative ( https://www. covid19hg. org/ ),as appropriate and consistent with achieving the goals of the program..

Application budgets should not exceed the annual amount of the current parent award and should reflect the actual needs of the proposed project. Exceptions will be considered on a case-by-case basis. Competitive revision applications to PA-20-135 must use the application form package with the Competition ID containing “NOT-RM-20-015."

NIH will accept applications using form packages with the Competition IDs of “NOT-RM-20-015-FORMS-E" or “NOT-RM-20-015-FORMS-F" until June 19, 2020. Submissions to PA-20-135 must be completed by June 19, 2020. An application submitted in response to this NOSI that is received on June 20, 2020 or later will be withdrawn.

IMPORTANT: For funding consideration, all applicants must designate “NOT-RM-20-015” (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 terms of this NOSI will be not be considered for the NOSI initiative.

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by OSC 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 emergency 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 emergency time frame feasible for the proposed research?

Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project? Data sharing plan: Are there timely plans to make results and data findable and accessible to the research community?

Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officer listed on the Notice of Award for the parent award to discuss whether the proposed project conforms with the policies and procedures of the specific administering Institute or Center.

Investigators are also encouraged to contact the program officer listed below to discuss the proposed project in the context of the Common Fund interests. Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

Funds awarded using appropriations provided by the Coronavirus Aid, Relief, and Economic Security (CARES) Act will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Please direct all inquiries to: Scientific/Research Contact(s) Office of Strategic Coordination (OSC) Office of the Director (OD) Financial/Grants Management Contact(s) Office of Strategic Coordination (OSC) Office of the Director (OD) Weekly TOC for this Announcement NIH... Turning Discovery Into Health ®