The Office of Orphan Products Development of the Food and Drug Administration has announced that February 7, 2007, will be the due date for receipt of grant applications for Fiscal Year 2008. It is anticipated that $14.2 million will be available for new applications, competing awards, and non-competing continuation awards.

These grant awards will support clinical trials on the safety and effectiveness of products for rare diseases and conditions. The studies are intended to provide data that will 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. Rare diseases or conditions are defined as ones with a prevalence of fewer than 200,000 people in the United States.

A complete text of the FDA request for applications (RFA) is available in the Federal Register (FR) notice, dated December 19, 2005, or at www.fda.gov/orphan/grant. Questions related to administrative or financial management aspects of this notice should be directed to Usha Ganti, Supervisory Grants Management Specialist, Division of Contracts and Grants Management (HFA-500), FDA, 5600 Fishers Lane, Rockville, Md., 20857; (301) 827-7182; usha.ganti@fda.hhs.gov.

Questions related to the program aspects of this notice should be directed to Debra Y. Lewis, OD, Director, OOPD Grant Program (HF-35), FDA, 5600 Fishers Lane, Rockville, Md., 20857; (301) 827-0059; debra.lewis@fda.hhs.gov. To request a copy of the Dec. 19, 2005, FT notice, call (301) 827-3666 or (800) 300-7469 or fax a request to (301) 827-0017.