Agenda: At the workshop, FDA will receive questions and comments from stakeholders likely to be affected by FDA policies or procedures regarding SARS diagnostic tests. Stakeholders include, but are not limited to, medical device product manufacturers, members of the academic and clinical communities, and consumer and patient advocacy groups.
Registration: Preregistration is required by July 7, 2003, and will be accepted on a first-come, first-served basis; however, notwithstanding attendance at the workshop, interested persons are encouraged to provide comments (see theRequest for Commentssection of this document). Please register online athttp://www.fda.gov/cdrh/meetings/071403.html. Persons without Internet access may call 1-888-203-6161 to register. To accommodate overnight attendees, a limited number of reserved rooms are available by calling the DoubleTree Rockville Hotel and Conference Center (see theAddressessection of this document). Please register with the hotel by June 30, 2003. FDA is pleased to provide the opportunity for interested persons to listen from a remote location to the live proceedings of the workshop. In order to ensure that a sufficient number of call-in lines are available, please register to listen to the meeting athttp://www.fda.gov/cdrh/meetings/071403.html. Persons without Internet access may call 1-888-203-6161 to register. Please register by July 7, 2003. FDA will provide audio conference participants the opportunity for comments and questions by fax (fax number to be provided at the workshop).
If you need special accommodations due to a disability, please contact Shirley Meeks at 301-594-1283 at least 7 days in advance.
Request for Comments: Regardless of attendance at the workshop, interested persons may submit written or electronic comments to the Division of Dockets Management (see theAddressessection of this document). Submit two paper copies of any mailed comments. Individuals may submit one paper copy. Identify comments with the docket number found in brackets in the heading of this document. The comments that FDA receives will be made available at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Transcripts: Following the workshop, transcripts will be available for review at the Division of Dockets Management (see theAddressessection of this document).