Notice to Change the Application Due Date for PAR-19-190 - "Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional"

Notice Number: NOT-FD-19-011

Key Dates
Release Date: April 10, 2019

Related Announcements
PAR-19-190

Issued by
FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

FDA's PAR-19-190 - Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) has made updates to its section on page 2 titled "Application Due Date(s) ". The due date for FY 19 has been changed to May 15, 2019 , by 11:59 PM Eastern Time. See revised sections below:

Application Due Date(s): May 15, 2019, by 11:59 PM Eastern Time.
April 4, 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
Shashi Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Shashi.Malhotra@fda.hhs.gov