Notice of Change to PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional)

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Notice Number: NOT-TR-19-014

Key Dates
Release Date:January 29, 2019

Related Announcements
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 Overall and NRSA Training core.

Instructions are effective for due dates on and after April 15, 2019.

The following changes are:

Section IV. Application and Submission Information

2. Content and Form of Application Submission

Overall Component

Research Plan (Overall)

Currently reads:

Letters of Support: Letters of Support should affirm the institution is in agreement with participation in the CTSA Program as a hub and as part of a collaborative translational science consortium. Considerations include how the applicant institution and any partner institutions anticipate participation in NIH programs with full reliance on a single IRB, the use of pre-negotiated master subcontracts, and providing transparent fee for service cost listings for research items associated with NIH multi-site clinical trials.

The application must include a letter of support from an authorized institutional official stating that the institution is willing to work under a central IRB, is willing to use master subcontract agreements/trial agreements (see for example https://www.ott.nih.gov/resources#MCRDA) and is willing to work under a transparent cost structure for per patient cost.

There is no cost sharing requirement under this FOA. Indication of institutional resources provided to contribute to the success of the Program will be considered positively in the programmatic evaluation of applications. Examples may include ensuring adequate facilities or providing additional support to ensure successful collaborations.

The application is also expected to include letters from the officials responsible for intellectual property issues at the applicant institutions (including sub-contractor institutions) stating that the institution supports and agrees to abide by any Resources and Data Sharing Plan and the Software Sharing Plan submitted in the application. These letters should be clear expressions of commitment consistent with achieving the goals of the Program. Applicants are encouraged to limit their letters of support to no more than 30.

Revised to read:

Letters of Support: Letters of Support should affirm the institution agrees to participate in the CTSA Program as a hub and as part of a collaborative translational science consortium. Letters should address how the applicant institution and any partner institutions anticipate participating in NIH programs, including reliance on a single IRB, the use of pre-negotiated master subcontracts, and provision of transparent fee for service cost listings for research items associated with NIH multi-site clinical research.

The application must include a letter of support from an authorized institutional official stating that the institution is willing to comply with the NIH single IRB policy for multi-site research and in particular is willing to sign or is a current signatory to the CTSA Program SMART IRB Reliance Agreement, is willing to use master subcontract agreements/trial agreements (see for example https://www.ott.nih.gov/resources#MCRDA) and is willing to work under a transparent cost structure for per patient cost.

There is no cost sharing requirement under this FOA. Indication of institutional resources provided to contribute to the success of the Program will be considered positively in the programmatic evaluation of applications. Examples may include ensuring adequate facilities or providing additional support to ensure successful collaborations.

The application is also expected to include letters from the officials responsible for intellectual property issues at the applicant institutions (including sub-contractor institutions) stating that the institution supports and agrees to abide by any Resources and Data Sharing Plan and the Software Sharing Plan submitted in the application. These letters should be clear expressions of commitment consistent with achieving the goals of the Program. Applicants are encouraged to limit their letters of support to no more than 30.

J. NRSA Training Core

Currently reads:

PHS 398 Training Subaward Budget Attachment (Training Core)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff

The NRSA Training Core is an optional part of the CTSA Program U54 application and will be funded only if the U application is successful. The training component provides stipends at a subsistence allowance to help defray living expenses during the research and clinical training experiences. The maximum budget for a training core is $400K direct cost (DC) for small hubs (total anticipated CTSA amount <$4.5M DC), $600K DC for medium hubs (total anticipated CTSA amount $4.5-$6M DC), and $800K (DC) for large hubs (total anticipated CTSA amount >$6M-$7.5M DC). The amount budgeted per pre-doctoral and post-doctoral trainee must comply with the NRSA stipend levels and allowable costs specified below. If an institution is currently funded under RFA-TR-12-006, RFA-TR-14-009, or PAR-15-304, and if the budget of the NRSA Training Core for the final year of the award period exceeds the amount allowed under this FOA, then applicants may choose to describe a transition period of up to three years for currently appointed trainees only to complete the planned training as described in the current award. This is to allow for a transition to the new budget limits, to lessen the impact on ongoing training and career development and to provide applicants budget flexibility for currently appointed TL1 trainees within the limits of the Subaward Budget as described in this section.

Part A: The application should request stipends for trainees.

Part B: Enter the total costs for Trainee Travel, and training related expenses, following the guidance, below:

Other Direct Costs: Trainee Travel: Enter the total costs for Trainee Travel, and training related expenses, following the guidance, below:

While the maximum request is explained under Budget information, the awarded slots will depend upon the scientific and technical merit of the proposed program as determined by scientific peer review and the relevance of the proposed program to programmatic priorities. Further consideration will address program goals and resources, educational resource sharing, and the availability of funds. Applicants should expect that final budgets may be adjusted post-review depending on these factors.

Revised to read:

PHS 398 Training Subaward Budget Attachment (Training Core)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

The NRSA Training Core is an optional part of the CTSA Program U54 application and will be funded only if the U application is successful. The training component provides stipends at a subsistence allowance to help defray living expenses during the research and clinical training experiences. The maximum budget for a training core is $400K direct cost (DC) for small hubs (total anticipated CTSA amount <$4.5M DC), $600K DC for medium hubs (total anticipated CTSA amount $4.5-$6M DC), and $800K (DC) for large hubs (total anticipated CTSA amount >$6M-$7.5M DC). The amount budgeted per pre-doctoral and post-doctoral trainee must comply with the NRSA stipend levels and allowable costs specified below. If an institution is currently funded under RFA-TR-12-006, RFA-TR-14-009, or PAR-15-304, and if the budget of the NRSA Training Core for the final year of the award period exceeds the amount allowed under this FOA, then applicants may choose to describe a transition period of up to three years for currently appointed trainees only to complete the planned training as described in the current award. This is to allow for a transition to the new budget limits, to lessen the impact on ongoing training and career development and to provide applicants budget flexibility for currently appointed TL1 trainees within the limits of the Subaward Budget as described in this section.

Part A: The application should request stipends for trainees.

Part B: Enter the total costs for Trainee Travel, and training related expenses, following the guidance, below:

Other Direct Costs: Trainee Travel: Enter the total costs for Trainee Travel (up to $1500 per year per trainee), and training related expenses, following the guidance, below:

While the maximum request is explained under Budget information, the awarded slots will depend upon the scientific and technical merit of the proposed program as determined by scientific peer review and the relevance of the proposed program to programmatic priorities. Further consideration will address program goals and resources, educational resource sharing, and the availability of funds. Applicants should expect that final budgets may be adjusted post-review depending on these factors.

All other aspects of the FOA remain unchanged.