Notice to Extend Application Deadline ,Change of Funds Available and Award Budget for RFA-FD-19-029 "Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed)."

Notice Number: NOT-FD-19-014

Key Dates
Release Date: July 17, 2019

Related Announcements

Issued by


This Notice is to update the following subsections of RFA-FD-19-029 "Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed)."

Application Due Date(s)

August 5, 2019 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 and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

Late applications will not be accepted for this FOA.

Expiration Date

August 6, 2019

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support.

FDA/Center for Drug Evaluation and Research intends to fund up to $2,100,000 for fiscal year 2019 in support of this program.

It is anticipated that up to one (1) award will be made, not to exceed $2, 100,000 in total costs (direct plus indirect), per award

Award Budget

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: $2,100,000


Please direct all inquiries to:

Financial/Grants Management Contact(s)

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration

Scientific/Research Contact(s)

Elektra Papadopoulos
Clinical Outcome Assessment Qualification Program
Center for Drug Evaluation and Research (CDER)
Telephone: 301-796-0967