Assistant Secretary for Planning and Evaluation	Search

NDA 21-649 Ms. Nancy L. Buc
Ms. Deborah Livornese
Buc & Beardsley
919 Eighteenth Street,
N.W. Washington, D.C. 20006-5503

Dear Ms. Buc and Ms. Livornese:

We wrote to you on August 24, 2007, indicating that we would need additional time to complete our response to your complaint and request for correction (received on May 15, 2007) and complaint amendment (received on June 26, 2007) pursuant to the Information Quality Act (also referred to as the Federal Data Quality Act).

Under FDA’s information quality guidelines, which are part of the Department of Health and Human Services’ Guidelines for Ensuring the Quality of Information Disseminated to the Public, the goal of FDA is to respond to such requests within 60 days of the receipt of the amendment, either by issuing a decision or by informing you that more time is required to respond to the complaint, explaining why, and providing you with an estimated decision date.

At this time, we are continuing to prepare a response to your request but will need more time to coordinate Agency review since your request raises complex issues. We anticipate that a response will be forwarded to you by December 21, 2007.

Sincerely,

John K. Jenkins, M.D., F.C.C.P. Director Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration

cc: Jane Axelrad Laurie Lenkel Gerald Masoudi