Notice of Availability of Funds to Support Clinical trials on the Safety and Effectiveness of Products for Rare Diseases

Notice Number: NOT-FD-06-001

Key Dates
Release Date: November 7, 2006

Issued by
Food and Drug Administration (

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  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 program aspects of this notice, please contact:: 

Debra Y. Lewis, O.D.,
Director, OPD Grants Program (HF-35)
Office of Orphan Products Development
5600 Fishers Lane,  Room 6A-55
Rockville, Maryland 20857;
Phone: 301-827-0059; e-mail: 

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

Usha Ganti,
Chief Grants Management Officer,
Division of Contracts and Grants Management (HFA-500)
Office of Acquisitions and Grants Services
5630 Fishers Lane,  Room 2107
Rockville, Maryland 20857
Phone: 301-827-7182; e-mail: 

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/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:

For more information regarding the Office of Orphan Products Development please visit the following website:

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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