Notice Number: NOT-AI-20-045

Key Dates
Release Date: April 28, 2020

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to correct the eligibility information in RFA-AI-20-029 Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) (U01 Clinical Trial Optional).

The following change has been made:

Part 2. Full Text of Announcement

Section III. Eligibility Information

3. Additional Information on Eligibility

Currently reads:

Only two applications per institution (normally identified by having a unique DUNS number or NIH IPF number) are allowed. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Revised to read:

Institutions (normally identified by having a unique DUNS number or NIH IPF number) may submit up to two applications per institution provided that the trials or studies described in the applications are independent of each other and target different, non-overlapping patient populations. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Nancy D. Bridges, MD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3535
Email: [email protected]