Update in Funds Available and Anticipated Number of Awards , Award Budget and Award Project Period Sections of RFA-FD-08-018 - Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models

Notice Number: NOT-FD-18-009

Key Dates
Release Date: April 24, 2018

Related Announcements
RFA-FD-18-018  

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

FDA's RFA-FD-18-018 - Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models has made updates to its sections on page 6 titled " Funds Available and Anticipated Number of Awards, Award Budget and Award Project Period". See revised sections below:

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 and include future recommended support for one (1) additional year contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/Center for Drug Evaluation and Research intends to fund up to $600,000, for fiscal year 2018 in support of this grant program.

 It is anticipated that up to two (2) awards will be made, not to exceed $300,000 in total costs (direct plus indirect), per year, 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: $300,000
YR 02: $300,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is two (2) years.

 

Inquiries

Please direct all inquiries to:

Eleftheria Tsakalozou, PhD
DQMM/ORS/OGD/CDER/FDA
Telephone: 240-402-2726
Eleftheria.tsakalozou@fda.hhs.gov