Notice of Special Interest (NOSI): New Administrative Supplement Applications to UL1 and U24 CTSA Awards to Address COVID-19 Public Heath Need
Notice Number:
NOT-TR-20-029

Key Dates

Release Date:
June 15, 2020
First Available Due Date:
June 12, 2020
Expiration Date:
November 11, 2020

Related Announcements

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 need for projects that address the coronavirus disease 2019 (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) from current Clinical and Translational Science Award (CTSA) UL1 and U24 award recipients as follows:

FOA

Responsive Activity

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; collection and analysis of COVID-19 health records

1-2

UL1 Components Only

PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional)

PAR-18-464 Clinical and Translational Science Award (U54 Clinical Trial Optional)

PAR-15-304 Clinical and Translational Science Award (U54 Clinical Trial Optional)

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

Support of the NCATS National COVID Cohort Collaborative (N3C): 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)

5-10

Use of informatics solutions to diagnose cases

1-5

Use of CTSA-supported core resources (e.g., advanced scientific instruments, highly-specialized facilities, and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics, therapeutics, and vaccines

1-5

Applicants are encouraged to:

  • Consider pursuing areas that are not well addressed.
  • Consider the feasibility of successfully enrolling a study/trial; recruitment of adequate numbers of subjects at single site may be challenging as the number of concurrent trials multiplies and the number of cases is potentially decreasing.
  • Consider avoiding trials needing an Investigational New Drug (IND) filing; these Prior Approval requests will be lengthy given the higher risk nature of the trial.
  • Consider undertaking longitudinal or cross-sectional observational studies to establish the natural history of COVID-19; these studies could be more feasible and provide valuable information.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following target opportunity or subsequently reissued equivalents through the expiration date of this notice. Designate “NOT-TR-20-029” (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.

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-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-20-029” (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 within 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 maximum supplement project period is 12 months. Upon application review, NCATS may split the 12-month award between the remaining time in the current and future budget periods in order to provide the full 12 months of funding support and time.
  • 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 application should be submitted electronically using the single component option. The single component option enables cooperative agreement mechanisms to submit electronically. Multi-component supplements cannot be submitted electronically at this time. Therefore, ensure to select single component when initiating the administrative supplement electronic application.
  • Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains “FORMS-F-ADMINSUPP”. The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
  • Funds awarded using appropriations provided by the H.R.748 (PL 116-136) – 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.
  • 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.

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.


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