December 11, 2023
National Center for Advancing Translational Sciences (NCATS)
The purpose of this Notice is to add NOT-TR-18-025 National Center for Advancing Translational Sciences (NCATS) Policy for Support of Phase III Clinical Trial Activities for a Rare Disease or Condition and NOT-TR-22-008 Notice of Change to Expansion of Eligibility of Optional Companion Applications for CTSA Program Funding Opportunities: PAR-21-293 (UM1), PAR-21-340 (RC2), PAR-21-339 (R25), PAR-21-338 (T32), and PAR-21-337 (T32) to the Related Notices section of PAR-24-054 Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Optional)
This Notice also serves to add the following language to Section I. Notice of Funding Opportunity Description/Applications Not Responsive to this NOFO in PAR-24-054:
Funds may not directly support any clinical trial beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed. See NOT-TR-18-025.
In addition, the following receipt date is corrected in the Application Due Dates and Review and Award Cycles Table within the NOFO:
Currently Reads
Renewal/Resubmissions/Revision (as allowed):
May 16, 2025
Modified to Read:
Renewal/Resubmissions/Revision (as allowed)
May 19, 2025.
All other aspects of this NOFO remain the same.
Pablo Cure, MD., MPH.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2014
Email: RC2NOFO@nih.gov