00-21719. Clinical Laboratory Improvement Advisory Committee (CLIAC): Meeting

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 meetings.

Name: Clinical Laboratory Improvement Advisory Committee (CLIAC).

Times and Dates: 8:30 a.m.-5 p.m., September 27, 2000, 8:30 a.m.-3:30 p.m., September 28, 2000.

Place: CDC, Koger Center, Williams Building, Conference Rooms 1802 and 1805, 2877 Brandywine Road, Atlanta, Georgia 30341.

Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 85 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 of proposed revisions to the standards; and the modification of the standards to accommodate technological advances.

Matters to be Discussed: The morning session of the first day will be devoted to orientation of new members. The orientation is background information on the process for new committee members. Although members of the public may attend, the orientation is not part of the public meeting. The agenda will include an orientation of new members, workgroup report on specimens and test systems not currently regulated under Clinical Laboratory Improvement Amendments (CLIA), and updates from CDC, Food and Drug Administration and Health Care Financing Administration.

The Committee solicits oral and written testimony on specimens and test systems not currently regulated under CLIA. Requests to make an oral presentation should be submitted in writing to the contact person listed below by close of business, September 20, 2000. All requests to make oral comments should contain the name, address, telephone number, and organizational affiliation of the presenter.

Written comments should not exceed five single-spaced typed pages in length and should be received by the contact person listed below by close of business, September 20, 2000.

Agenda items are subject to change as priorities dictate.

Contact Person for Additional Information: Rhonda Whalen, Acting Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, Public Health Practice Program Office, CDC, 4770 Buford Highway, NE, Mailstop F-11, Atlanta, Georgia 30341-3724, telephone [phone], fax [phone].

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.

Dated: August 18, 2000.

Carolyn J. Russell,

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