Notice Number: NOT-FD-16-003

Key Dates
Release Date: December 22, 2015
Estimated Publication Date of Announcement: March 2016
First Estimated Application Due Date: June 2016
Earliest Estimated Award Date: September 2016
Earliest Estimated Start Date: September 2016

Issued by
Food and Drug Administration (FDA)

Purpose

This Notice is to inform potential applicants of the Food and Drug Administration's (FDA) intent to publish a Funding Opportunity Announcement (FOA) for “Physiology Parameter Measurements in Human Bridging the Gaps for Mechanistic Pharmacokinetic and Pharmacodynamic Modeling (U01)” to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects and encourages teams with complementary expertise in conducting studies in humans to apply for this new FOA.

In 2014, FDA funded several research studies to develop physiologically based absorption and pharmacokinetic modeling and simulation for non-gastrointestinally absorbed drug products in humans to facilitate complex generic drug products guidance preparation, development of generic formulations by industry, and generic drug products evaluation. During the model development process, one of the gaps identified was the lack of physiological parameters both in healthy subjects and in patient populations. Proposed applications will conduct studies in humans (healthy subjects and/or corresponding patient populations) to collect the physiological parameters that are needed but not reported to develop mechanism based models for generic drug development and regulatory review. The areas of interest include ophthalmic, pulmonary, nasal, and dermatological drug products.

The FOA is expected to be published in March 2016 with an expected application due date in June 2016. Applications for this FOA will be electronic and be submitted through the Grants.gov. This FOA will utilize the U01 activity code.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all scientific/programmatic inquiries to:
Xinyuan Zhang, Ph.D.
DQMM/ORS/OGD/CDER/FDA
10903 New Hampshire Ave., Bldg. 75, Room 4612
Silver Spring, MD 20993
Telephone: 240-402-7971
Email: Xinyuan.Zhang@fda.hhs.gov

Please direct all grants administrative inquiries to:
Eric Bozoian
Grants Management Specialist
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7623
Email: Eric.Bozoian@fda.hhs.gov