E7-720. Clinical Laboratory Improvement Advisory Committee

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). Web site: http://www.phppo.cdc.gov/​CLIAC/​default.aspx.

Times and Dates: 8:30 a.m.-5 p.m., February 14, 2007; 8:30 a.m.-3 p.m., February 15, 2007.

Place: Omni Hotel at CNN Center, 100 CNN Center, Atlanta, Georgia 30303; Phone: [phone], Fax: [phone] (http://www.omnihotels.com/​FindAHotel/​AtlantaCNNCenter.aspx).

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 the CDC, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration; discussion of the status of the “Notice of Proposed Rulemaking” for genetic testing; presentations and discussion concerning the future of health laboratory practice specifically focusing on simple testing in diverse sites; reports and discussions addressing the impact of the Morbidity and Mortality Weekly Report (MMWR) Publication of “Good Laboratory Practices for Waived Testing Sites”; a report from the CLIAC Workgroup on “The Impact of Rapid and Molecular Tests for Infectious Disease Agents on Public Health” and discussion of the workgroup's proposals related to such; and presentations and discussion concerning rapid HIV testing. 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 meeting's summary report. To assure adequate time is scheduled for public comments, individuals or groups planning to make an oral presentation should, when possible, notify the contact person below at least one week prior to the meeting date.

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 meeting's summary report.

Contact Person for Additional Information: Devery Howerton, Acting Chief, Laboratory Practice Standards Branch, Division Public Health Partnerships—Laboratory Systems, National Center for Health Marketing, Coordinating Center for Health Information and Service, CDC, 1600 Clifton Road, NE., Mailstop G-23, Atlanta, Georgia 30333; telephone [phone]; fax [phone]; or via e-mail at [e-mail].

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 CDC and the Agency for Toxic Substances and Disease Registry.

Dated: January 12, 2007.

Edward Schultz,

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