The Food and Drug Administration's (FDA) Office of Orphan Products Development (OPD) is pleased to announce the availability of funds for fiscal year (FY) 2008 grant awards to support clinical trials on the safety and effectiveness of products for rare diseases and conditions. Contingent on availability of FY 2007 and FY 2008 funds, it is anticipated that $14.2 million will be available for new applications, competing awards, and non competing continuation awards. 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 OPD 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.

See Notice in NIH Guide: NOT-FD-06-001