Department of Health
and Human Services (HHS)
and Human Services (HHS)
May 26, 2021
PAR-21-237 - NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required)
National Institute of Neurological Disorders and Stroke (NINDS)
The purpose of this notice is to inform applicants of a correction to the Funding Period for the initial milestone-driven Planning Phase (UG3) in Funding Opportunity Announcement (FOA) PAR-21-237 "NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required)". The UG3 planning phase will last for up to 1 year, with a possible transition to the clinical phase. Changes to the Funding Opportunity Announcement (FOA) are listed below.
The following section of PAR-21-237 has been modified:
Currently Reads:
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Funding period: The grant mechanism used to support this funding announcement is a cooperative agreement (UG3/UH3) mechanism with two phases. The initial milestone-driven planning phase (UG3) will last for up to 2 years, with possible transition to the clinical phase, as outlined below. Only UG3 projects that have met scientific milestones and feasibility requirements will be approved to transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application. The UG3 phase will permit both scientific and operational planning activities. The UH3 phase of the award will support the clinical trial of the drug, biologic or device.
The UG3 Phase may not exceed 1 year.
The UH3 Phase may not exceed 4 years.
The total length of the project may not exceed 5 years.
Modified to Read (changes shown in bold italics):
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Funding period: The grant mechanism used to support this funding announcement is a cooperative agreement (UG3/UH3) mechanism with two phases. The initial milestone-driven planning phase (UG3) will last for up to 1 year, with possible transition to the clinical phase, as outlined below. Only UG3 projects that have met scientific milestones and feasibility requirements will be approved to transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application. The UG3 phase will permit both scientific and operational planning activities. The UH3 phase of the award will support the clinical trial of the drug, biologic or device.
The UG3 Phase may not exceed 1 year.
The UH3 Phase may not exceed 4 years.
The total length of the project may not exceed 5 years.
All other aspects of this FOA remain unchanged.
Jeremy Brown, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]