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. The next due date for receipt of FY 2008 grant applications is February 7, 2007.

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.

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/grants. FDA will support the clinical studies covered by this notice under section 301 of the Public Service Act (42 U.S.C. 241). Regarding the administrative and financial management aspects of this notice, please contact:

Usha Ganti, Supervisory Grants Management Specialist
Division of Contracts and Grants Management (HFA-500)
FDA
5600 Fishers Lane
Rockville, Maryland 20857
301-827-7182
e-mail: usha.ganti@fda.hhs.gov

Regarding the program aspects of this notice, please contact:
Debra Y. Lewis, O.D., Director, OPD Grant Program (HF-35)
FDA
5600 Fishers Lane
Rockville, Maryland 20857
301-827-0059
e-mail: debra.lewis@fda.hhs.gov

To request a copy of the December 19, 2005 FR notice, please phone the OPD office at 301-827-3666/1-800-300-7469 or send a fax request to 301-827-0017.

Information by E-Mail or Web site

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For more information regarding the Office of Orphan Products Development please visit the following website: http://www.fda.gov/orphan