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FDA — OMEGA Letter: Interim Response, November 18,2005

Date: November 18,2005

To: Jay Davis, President, Omega Laboratories, Inc.

RE: Request for Correction (Removal) of Information Found On the OIVD Section of the FDA Web Site

Dear Mr. Davis:

This letter is an interim response to your May 23, 2005, request for correction of information pursuant to the Federal Data Quality Act [Section 515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub.L. No. 106-554,114 Stat. 2763A-153 (2000)], HHS Information Quality Guidelines and the FDA's Guidelines for Ensuring the Quality of Information Disseminated to the Public.

Preparation of a response requires adequate time to conduct a thorough review of the materials submitted and to hold internal discussions. Unfortunately, we have not been able to complete our response in time to meet the November] 8,2005, deadline. We now anticipate responding to your request by January 17,2006.

Laurie Lenkel 
Office of the Ombudsman 
Food and Drug Administration