Notice Number: NOT-FD-08-001
Release Date: September 24, 2007
Issued by: Food and Drug Administration/Office of Orphan Products Development and Food and Drug Administration

The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce the availability of funds for fiscal year (FY) 2009 and FY 2010 grant awards to support clinical trials on the safety and effectiveness of products for rare diseases and conditions. Contingent on availability of FY 2009 and FY 2010 funds, it is anticipated that $14.2 million will be available for new applications, competing awards, and non competing continuation awards. For FY 2009, the application receipt date is February 6, 2008, and for FY 2010, the application receipt date is February 4, 2009.

These studies are intended to provide acceptable data to the FDA that will substantially contribute to the approval of new products, or new indications for already marketed products. In the FDA OOPD grants program, products for rare diseases and conditions (orphan products) are defined as drugs, biologics, medical devices, and medical foods indicated to treat or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the United States.

To read the complete notice, click here.

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Participating Organizations: Food and Drug Administration (FDA)

Components of Participating Organizations: Office of Orphan Products Development (OPD)

Title: Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01)

Request for Application (RFA) Number: RFA-FD-08-001

Opening Date: January 6, 2008 (Earliest date an application may be submitted to Grants.gov)

Application Submission/Receipt Date(s): February 6, 2008; February 4, 2009

Expiration Date: February 5, 2009

For more information, click here. For additional funding opportunities from the National Institutes of Health, click here.