Notice Number: NOT-FD-20-015

Key Dates
Release Date: March 11, 2020

Issued by
FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

This Notice is to extend the Application Due Date for PAR-19-216 titled "Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional."

The New Application Due Date is:

New Application Due Date(s)

April 6, 2020, by 11:59 PM Eastern Time.

April 5, 2021, by 11:59 PM Eastern Time.
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.
Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

Late applications will not be accepted for this FOA.

Inquiries

Please direct all inquiries to:

Shashi Malhotra
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grants Services, HFA-500
U.S. Food and Drug Administration
Tel: 301-402-7592
shashi.malhotra@fda.hhs.gov