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FDA — OMEGA Letter: Interim Response, September 20, 2005

Date: September 20, 2005

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:

Your request for correction of information appearing on the FDA Website, specifical1y infoID1ation by the Office of In Vitro Diagnostic Device Evaluation and Safety, is stil1 under review. Under FDA Guidelines for Ensuring the Quality ofInfoID1ation Disseminated to the Public the goal is to respond to each request for correction within 60 days of receipt either by providing a decision on the request or, if the request will require more than 60 days to complete, informing the complainant that more time is required.

We wrote to you on July 22,2005, indicating that we would need additional time to complete our response to your request and expected to reply by September 20, 2005. Unfortunately, we wil1 not be able to meet this date. At this time we are continuing to prepare our response and anticipate responding by November 18, 2005.


Laurie Lenkel, Office of the Ombudsman Food and Drug Administration