Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions and Administrative Supplements to Clinical and Translational Science Award (CTSA) Program Awards to Address 2019 Novel Coronavirus Disease (COVID-19) Public Health Needs

Notice Number: NOT-TR-20-028

Key Dates
Release Date: April 23, 2020
First Available Due Date: May 04, 2020
Expiration Date: November 11, 2020

Related Announcements

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

PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

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. NCATS is soliciting applications for Administrative Supplements (through PA-18-591) and Emergency Competitive Revisions (through PA-20-135) from current Clinical and Translational Science Award (CTSA) UL1 and U24 award recipients as follows:

FOA

Responsive Activities

Expected Number of Awards

RFA-TR-17-006 CTSA Program Data to Health (CD2H) Coordinating Center (U24)

Digital health platforms and models that integrate data, assess risk, and provide illness/infection surveillance, management tools, and inform clinical practice

1

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)

Planning of COVID-19 trials; additional recruitment and retention support; eConsent support; and provision of a platform and statistical expertise to collect and perform meta-analyses of COVID-19 therapeutic trials

1-4

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

RFA-TR-14-009 Clinical and Translational Science Award (U54 Clinical Trial Optional) UL1 Component Only

Provision of clinical data in specified formats to support illness/infection status/surveillance determinations and/or clinical study data (awards anticipated to be $50,000 to $100,000 Total Costs)

5-15

Involvement with clinical studies and trials in support of COVID interventions, as well clinical sample provision and assessing infectious or convalescent status

1-10

Application and Submission Information

Applications in response to this NOSI must be submitted using one of the following target opportunities or subsequently reissued equivalents. Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice and designate “NOT-TR-20-028” (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form as directed below.

  • PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional), which is intended to provide additional funds for NIH grantees for work that falls within the scope of their active grant.
  • 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.

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-20-135PA-18-591) must be followed, with the following additions:

  • Applications will be accepted immediately and on a rolling basis through November 10, 2020 by 5:00 PM local time of the applicant organization. This NOSI expires on November 11, 2020. An application submitted in response to this NOSI that is received on November 11, 2020 or later, will be withdrawn. Applications will be considered for funding in FY20 or FY21 pending: award timelines, availability of funds, and programmatic priority.
  • IMPORTANT: For funding consideration, all applicants must designate “NOT-TR-20-028” (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. Address assurances that the proposed project can be performed as described under the current Public Health Emergency circumstances.
  • 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.
  • 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 with strong justification and must reflect the actual needs of the proposed project.
  • Follow the FOA Instructions for Electronic Application Submission through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov workspace.
  • The administrative supplement or competitive revision application should be submitted electronically using the single component option. The single component option enables cooperative agreement mechanisms to submit electronically. Multi-components supplements cannot be submitted electronically at this time. Therefore, ensure to select single component when initiating the administrative supplement or competitive revision electronic application.
  • Competitive revision applications to PA-20-135 must use an application form package with the Competition ID containing “NOT-TR-20-028." NIH will accept applications using form packages with the Competition IDs of “NOT-TR-20-028-FORMS-E" or “NOT-TR-20-028-FORMS-F" until June 25, 2020. Applications submitted on or after June 25, 2020 must use “NOT-TR-20-028-FORMS-F.” See NOT-OD-20-026 for details.
  • Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains “FORMS-E-ADMINSUPP”. This FOA will be reissued with application form packages containing “FORMS-F-ADMINSUPP” 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. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
  • 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.
  • 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.

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 that do not meet the requirements specified in 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.