Notice Number: NOT-FD-08-001

Key Dates
Release Date:  September 24, 2007

Issued by
Food and Drug Administration/Office of Orphan Products Development (http://www.fda.gov/orphan)

Food and Drug Administration (http://www.fda.gov)

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. 

A complete text of the FDA request for applications (RFA) is available in the Federal Register (FR) notice, dated July 3, 2007, or at http://www.fda.gov/orphan/grants/2009RFA.html.  FDA will support the clinical studies covered by this notice under section 301 of the Public Service Act (42 U.S.C. 241). 

Inquiries

Regarding the program aspects of this notice, please contact: 

Debra Y. Lewis, O.D., M.B.A.
Director, OOPD Grants Program (HF-35)
Office of Orphan Products Development
FDA
5600 Fishers Lane,  Room 6A-55
Rockville, Maryland 20857;
Phone: 301-827-0059
e-mail: debra.lewis@fda.hhs.gov 

Regarding the administrative and financial management aspects of this notice, please contact:

Dianna Jessee
Grants Management Specialist
Division of Contracts and Grants Management (HFA-500)
FDA
5630 Fishers Lane,  Room 2141
Rockville, Maryland 20857
Phone: 301-827-7177
e-mail: dianna.jessee@fda.hhs.gov

To request a copy of the July 3, 2007 FR notice, please phone the OOPD office at 301-827-3666/1-800-300-7469 or send a fax request to 301-827-0017.

Information by E-Mail/Website

Subscribers to the FDA orphan products information listserv receive relevant Federal Register notices, up-to-date lists of orphan designations and approvals, and newsworthy items of interest to the orphan products community.  Subscribe at:  http://list.nih.gov/archives/orphanprodinfo.html
For more information regarding the Office of Orphan Products Development please visit the following website:  http://www.fda.gov/orphan

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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