Key Dates

Related Announcements

NOT-TR-23-024 - Notice of Early Termination of NOT-TR-21-022, Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for the Clinical and Translational Science Award (CTSA) Program to Address COVID-19 Public Health Needs.

PA-20-135 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)

NOT-TR-21-024 - Notice of Information: NCATS to Issue an Emergency Competitive Revision Sole Source Award in Support of ACTIV-6

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for projects that address the COVID-19 Public Health Emergency. The Clinical and Translational Science Award (CTSA) Program is uniquely qualified to contribute to these efforts by performing high-priority clinical studies and trials to test therapeutics for the Coronavirus Disease 2019 (COVID-19).

NCATS is soliciting applications for Emergency Competitive Revisions to Existing NIH Awards (through PA-20-135) from current Clinical and Translational Science Award (CTSA) UL1 and U24 award recipients for clinical studies and trials in support of COVID-19 therapeutic interventions as follows:

• RFA-TR-15-002- CTSA Network - Trial Innovation Centers (TICs) (U24)
• RFA-TR-15-004- Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs) (U24)
• PAR-18-940 - Clinical and Translational Science Award (U54 Clinical Trial Optional) UL1 Component Only
• PAR-18-464 - Clinical and Translational Science Award (U54 Clinical Trial Optional) UL1 Component Only
• PAR-15-304 - Clinical and Translational Science Award (U54 Clinical Trial Optional) UL1 Component Only

NCATS expects to issue 1-8 awards for clinical studies and trials in support of COVID-19 therapeutic interventions.

Application and Submission Information

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

• 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.

To be eligible, the parent Clinical and Translational Science Award (CTSA) Program award on which the revision application is based must be active when the application is submitted. The proposed project and budget periods must be within the currently approved project period for the existing parent award.

Eligibility for applications to PA-20-135 is limited to the UL1 and U24 activity codes.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-20-135) must be followed, with the following additions:

• Applications will be accepted immediately and on a rolling basis through August 16, 2024 by 5:00 PM local time of the applicant organization.
• IMPORTANT: For funding consideration, all applicants must designate NOT-TR-21-022 (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 project period will generally be limited to 1 year. Project periods up to 2 years will be considered only with strong justification.
• Application budgets may exceed the amount of the current parent award and must reflect the actual needs of the proposed project.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package.
• Applications must specifically address issues of potential biohazards in the Research Strategy, and all research must be conducted in compliance with the health and safety requirements found in the NIH Grants Policy Statement.
• Funds awarded using supplemental appropriations such as the Coronavirus Aid, Relief, and Economic Security (CARES) Act or the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (CRRSAA) or future supplemental appropriations will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact the Grants Management Specialist on their active award to determine eligibility and the Program Officer on their active award to discuss the proposed project in the context of the parent award.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Please contact the Program Officer on your active award.