Notice Number: NOT-TR-20-014
Release Date: April 8, 2020
First Available Due Date: May 04, 2020
Expiration Date: September 10, 2022
PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional)
National Center for Advancing Translational Sciences (NCATS)
National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to seek UL1 Administrative Supplements to add a dedicated quality assurance/quality control position to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process.
Translating biomedical discoveries into clinical applications is essential to improving human health. It is also a complex process with high costs and substantial failure rates. These failures can result in delays of years or decades before improved patient outcomes result from discoveries in biomedical research. Under NCATS’ leadership, the CTSA Program supports a national consortium of medical research institutions that work together to tackle system-wide scientific and operational changes that solve the many outstanding problems limiting the efficiency, effectiveness, and reach of clinical translational research, and thus get more treatments to more patients more quickly across the country. To do that, the program focuses on widely appreciated systematic barriers.
As with all NIH awards, several activities within the CTSA Program require formal NCATS Prior Approval, e.g., changes in key personnel, addition of a foreign component, and request to carryover funds. All new KL2 Scholar Projects and certain Pilot Projects that include human subjects research require formal Prior Approval, while certain new Pilot Projects that include human subjects research may require only the submission of documents and notification of NCATS prior to start. To facilitate consistency, efficiency, and enhance the submission of successful CTSA-related information packages to NCATS, this Notice seeks CTSA Program UL1 administrative supplements to support an individual to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:
Note: Supplement project and budget periods are limited to the current and each subsequent budget period remaining in the parent project period. To be eligible, the parent award must be active (i.e., not be in an extension period), and the activities proposed in the supplement must be accomplished within the remaining active budget period that started in the current fiscal year for the existing parent award. The earliest anticipated start date is July 1, 2020. All requested budgets should be pro-rated to time remaining in the current budget period starting no earlier than July 1, 2020.
Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.
Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.