Notice Number: NOT-TR-19-023

Key Dates
Release Date: June 24, 2019

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this notice is to update information regarding clinical trials in PAR-19-099 Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional).

Section II. Award Information

Currently Reads:

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Revised to Read:

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

As detailed in NOT-TR-18-025, NCATS is limited to direct support of clinical trials through phase IIB with the exception of phase III (21 CFR definition) clinical trials for treatment of a rare disease or condition. For NCATS to support a phase III clinical trial activity for a rare disease or condition, all policy guidance and statutory requirements stated in NOT-TR-18-025 must be followed, including a > 120 day public notice of NCATS' intent to fund the Phase III CT for a rare disease or condition and lack of a written credible response from any public or private organization that the organization has timely plans to conduct Phase III CTs of a similar nature. For details about the NCATS policy regarding support of phase III clinical trial activities for a rare disease or condition, see NOT-TR-18-025.

Inquiries

Please direct all inquiries to:

H. Timothy Hsiao, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8928
Email: [email protected]