Notice Number: NOT-TR-19-010
Key Dates
Release Date: November 7, 2018
PAR-18-940
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
This Notice amends PAR-18-940 "Clinical and Translational Science Award (U54 Clinical Trial Optional)" with updates to the Key Dates, Informatics component, Network Capacity component, and Institutional Career Development Award component. Instructions are effective for due dates on and after January 25, 2019.
Part I. Overview Information
Key Dates
Currently reads:
Advisory Council Review
October 2019, January 2020, May 2020, October 2020, January 2020, May 2021, October 2021, January 2022, May 2022
Revised to read:
Advisory Council Review
October 2019, January 2020, May 2020, October 2020, January 2021, May 2021, October 2021, January 2022, May 2022
Currently reads:
Earliest Start Date
December 2019, April 2020, July 2020, December 2020, April 2021, July 2021, December 2021, April 2022
Revised to read:
Earliest Start Date
December 2019, April 2020, July 2020, December 2020, April 2021, July 2021, December 2021, April 2022, July 2022
Section IV. Application and Submission Information
2. Content and Form of Application Submission
B. Informatics
Budget (Informatics)
Currently reads:
Budget forms appropriate for the specific component will be included in the application package.
Because of its broad scope and overarching importance, there is no recommended limit to scope and budget. Applicants should plan for robust informatics resources and strong personnel and leadership within a budget range adequate to the scope and critical importance of informatics which will likely exceed the range indicated for “other CTR Cores” described below.
Revised to read:
Budget forms appropriate for the specific component will be included in the application package.
Because of its broad scope and overarching importance, it is assumed that applicant institutions will have a robust Informatics framework in place with strong personnel and leadership that can be leveraged for the purpose of responding to this FOA. The Informatics budget request should be well-justified.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
G. Network Capacity
PHS 398 Research Plan (Network Capacity)
Research Strategy:
Currently reads:
Revised to read:
Applicants should include a brief description (preferably in a table) of all NIH funded multi-site clinical trials with site activation during the 6 months up to and prior to the application. Include the following metrics: time from contract received to execution, time from protocol received by the trial PD/PI (or time protocol finalized if local trial) to IRB approval, time from subcontract executed to first patient first visit, and time from IRB approval to first patient first visit. For multi-site studies, it is the date when the site is activated by the sponsor. The “contract received date” is the date the draft contract was received by the Institution (PD/PI or institutional contracting official), whichever comes first. The contract execution date is the date it was approved by the institution. For “brief description”, the title of the trial will suffice; applicants may add further description in addition to the title, as needed.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
I. Institutional Career Development Core
PHS 398 Training Subaward Budget Attachment (Institutional Career Development Core)
Currently Reads:
Follow the Instructions in the SF424 (R&R) Application Guide with the following additional modifications:
- Include all personnel other than the Core Lead(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
- Do not complete the section on Participant/Trainee Support Costs.
- The CTSA Program Institutional Career Development Program for translational researchers will be programmatically linked but will have a separate PD/PI when awarded, and a budget based on the number of scholars projected. The maximum number of scholars per year, for any size CTSA Program hub, is 9.
- If an institution is currently funded under the CTSA Program, and if the number of KL2 scholars currently provided through the CTSA Program award is greater than the number recommended in this FOA, then applicants may choose to describe a transition period of up to three years when needed to reduce the number of KL2 scholars. This is to allow for a transition to the new model, and to lessen the impact on ongoing career development. This gives applicants flexibility when budgeting for KL2 scholars within the limit of the Award Budget described in Section II.
- For each scholar, the following should be budgeted: Salary support will be provided up to $120,000. In general, 9 person-months (75 percent of the KL2 full-time professional effort) must be devoted to the KL2 program, except for those in surgical specialties, which can have less than 9 person-months (75 percent), but no less than 6 person-months (50 percent), protected time for this program, if sufficiently justified and programmatically approved. Additional support may be requested for research-related activities detailed below.
- The average total amount budgeted per scholar must not exceed $180,000 in direct costs per year.
Revised to Read:
Follow the Instructions in the SF424 (R&R) Application Guide with the following additional modifications:
- Include all personnel other than the Core Lead(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
- Do not complete the section on Participant/Trainee Support Costs.
- The CTSA Program Institutional Career Development Program for translational researchers will be programmatically linked but will have a separate PD/PI when awarded, and a budget based on the number of scholars projected . The number of scholars requested per year should be well-justified.
- For each scholar, the following should be budgeted: Salary support will be provided up to $120,000. In general, 9 person-months (75 percent of the KL2 full-time professional effort) must be devoted to the KL2 program, except for those in surgical specialties, which can have less than 9 person-months (75 percent), but no less than 6 person-months (50 percent), protected time for this program, if sufficiently justified and programmatically approved. Additional support may be requested for research-related activities detailed below.
- The average total amount budgeted per scholar must not exceed $180,000 in direct costs per year.
Inquiries
Please direct all inquiries to:
Mary Purucker, MD, PhD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0178
Email: CTSAFOAQuestions@mail.nih.gov
and Human Services (HHS)
