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FDA — OMEGA Letter: Interim Response, May 16, 2006

Date: May 16, 2006

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 request for correction pursuant to the Federal Data Quality Act, the HHS Information Quality Guidelines and the FDA's Guidelines for Ensuring the Quality ofInformation Disseminated to the Public. Yourrequest for correction of information appearing on the FDA Website, specifically information by the Office of In Vitro Diagnostic Device Evaluation and Safety, is sti1l under review.

We are continuing to prepare our response but need additional time to conduct a thorough review of the materials subrrutted and to hold internal discussions. We hope to provide you with a response within 60 days from the date of this letter.

Sincerely,

Laurie Lenkel 
Office of the Ombudsman Food and Drug Administration