NOT-AA-20-026: Notice to Extend the Expiration Date for PAR-18-580 "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 Clinical Trial Optional)"

Notice to Extend the Expiration Date for PAR-18-580 "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 Clinical Trial Optional)"

Notice Number:

NOT-AA-20-026

Key Dates

Release Date:

January 6, 2021

Related Announcements

PAR-18-580 - Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 Clinical Trial Optional)

Issued by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The purpose of this Notice is to extend the expiration date for PAR-18-580 "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (UT2 Clinical Trial Optional)" by one receipt cycle. PAR-18-580 will now expire on March 26, 2021.

Due to the extension, the following dates will be added:

Standard application due date : March 25, 2021.
Scientific Merit Review: July 2021
Advisory Council: October 2021

The following sections of the FOA have been changed:

Part 1. Overview Information, Key Dates

Currently reads:

Application Due Date(s): March 27, 2018; December 4, 2018; March 27, 2019; December 4, 2019; March 27, 2020; December 4, 2020, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review: July 2018, March 2019, July 2019, March 2020, July 2020, March 2021

Advisory Council Review: August 2018, May 2019, August 2019, May 2020, August 2020, May 2021

Expiration Date: December 5, 2020

Revised to read (changes shown in italics):

Application Due Date(s): March 27, 2018; December 4, 2018; March 27, 2019; December 4, 2019; March 27, 2020; December 4, 2020; March 25, 2021, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review: July 2018, March 2019, July 2019, March 2020, July 2020, March 2021, July 2021

Advisory Council Review: August 2018, May 2019, August 2019, May 2020, August 2020, May 2021, October 2021

Expiration Date: March 26, 2021

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Raye Z. Litten, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0636
Email: [email protected]