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Clinical Laboratory Improvement Advisory Committee (CLIAC)

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting.

Name: Clinical Laboratory Improvement Advisory Committee (CLIAC).

Times and Dates: 8:30 a.m.-5 p.m.; September 17, 2003. 8:30 a.m.-3:30 p.m.; September 18, 2003.

Place: Sheraton Colony Square Hotel, 188 14th Street NE., Atlanta, Georgia 30361.

Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people.

Purpose: This committee is charged with providing scientific and technical advice and guidance to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the need for, and the nature of, revisions to the standards under which clinical laboratories are regulated; the impact on medical and laboratory practice of proposed revisions to the standards; and the modification of the standards to accommodate technological advances.

Matters To Be Discussed: The agenda will include updates from CDC, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration; a report on the results of the General Services Administration's Office of Government-wide Policy Federal Advisory Committee Stakeholder Engagement Survey; presentations and discussion on the CLIA waiver criteria and process, previous CLIAC recommendations related to such, and AdvaMed's CLIAC waiver criteria proposal; a report on the Coordinating Council for Clinical Laboratory Workforce's June 2003 meeting; a report on the April 2003 Quality Institute; a summary of the March 2003 CLIAC meeting on direct access testing; a presentation on Lab Tests Online; a report on the first meeting of the Secretary's Advisory Committee on Genetics, Health and Society; and several presentations on CDC's various genetic testing activities.

Agenda items are subject to change as priorities dictate.

Providing Oral or Written Comments: It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments whenever possible. Oral Comments: In general, each individual or group requesting to make an oral presentation will be limited to a total time of five minutes (unless otherwise indicated). Speakers must also submit their comments in writing for inclusion in the meetings Summary Report. Written Comments: For individuals or groups unable to attend the meeting, CLIAC accepts written comments until the date of the meeting (unless otherwise stated). However, the comments should be received at least one week prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. Written comments, one hard copy with original signature, should be provided to the contact person below. Written comments will be included in the meetings Summary Report.

Contact Person for Additional Information: Rhonda Whalen, Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, Public Health Practice Program Office, CDC, 4770 Buford Highway, NE., Mailstop F-11, Atlanta, Georgia 30341-3717; telephone (770) 488-8042; fax (770) 488-8279; or via e-mail at RWhalen@cdc.gov.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry.

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Dated: August 20, 2003.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.

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[FR Doc. 03-22008 Filed 8-27-03; 8:45 am]

BILLING CODE 4163-18-P