Notice Number: NOT-FD-12-012

Key Dates
Release Date: June 1, 2012

Related Notices
PAR 11-209

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

Purpose

The following is a one time supplement to the current posted FOA “Data Concepts and Terminology Standards for Clinical Research and Drug Development”.  In addition to the funds available under PAR 11-209, and cohort of potential grant applications for priority therapeutic areas, the Center for Drug Evaluations and Research (CDER) has additional funds available in the amount of $500,000 for pandemic influenza threats and chemical, biological, radiological, and nuclear (CBRN) threats. Awards will be based on the programmatic relevance and funds availability.

These additional funds are made available through the Medical Countermeasures Initiative (MCMi), which focuses on efforts to enhance the Agency’s preparedness.  To utilize these funds, the scope of the grant application must meet the FOA requirements and the project must support the MCMi initiative.  Enhancing the ability to prepare and respond to public health emergencies is applicable to this FOA for where data concepts and terminology standards can improve review of products needed for response – specifically influenza.  This therapeutic area is one of specific areas of research interest due to its significant public health concerns.

For general information on the overall Medical Countermeasure Initiative please see: http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm

Inquiries

Please direct all inquiries to:

Gladys Melendez-Bohler, Grants Management Specialist
Food and Drug Administration
Office of Contract and Grant Services
301-827-7171 (Office)
301-827-1044 (Fax)
[email protected]