Notice of Change to the Application Due Date and correct Section II Award Information - Award Budget for RFA-FD-20-030 "Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01 Clinical Trials Optional")

Notice Number: NOT-FD-20-025

Key Dates
Release Date: April 7, 2020

Related Announcements
RFA-FD-20-030

Issued by
FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The purpose of this Notice is to extend the Application Due and to make a correction to Section II Award Information - Award Budget for RFA-FD-20-030 "Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional."

The New Application Due Date is:

June 05, 2020, 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.

Section II Award Information - Award Budget

Currently reads:

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $4,000,000

YR 02: $4,000,000

YR 03: $4,000,000


Should read:

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $2,000,000

YR 02: $2,000,000

YR 03: $2,000,000


All other aspects of this FOA remain unchanged.

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