2011-1999. Clinical Laboratory Improvement Advisory Committee (CLIAC)

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 meeting of the aforementioned committee:

Times and Dates:

9:15 a.m.-5 p.m., March 2, 2011

8:30 a.m.-12:30 p.m., March 3, 2011

Place: CDC, 1600 Clifton Road, NE., Tom Harkin Global Communications Center, Building 19, Room 232, Auditorium B, Atlanta, Georgia 30333.

Online Registration Required: In order to expedite the security clearance process at the CDC Roybal Campus located on Clifton Road, all CLIAC attendees are required to register for the meeting online at least 14 days in advance at http://wwwn.cdc.gov/​cliac/​default.aspx by clicking the “Register for a Meeting” link and completing all forms according to the instructions given. Please complete all the required fields before submitting your registration and submit no later than February 16, 2011.

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, Department of Health and Human Services; the Assistant Secretary for Health; the Director, CDC; the Commissioner, Food and Drug Administration (FDA); and the Administrator, Centers for Medicare and Medicaid Services (CMS), 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 agency updates from CDC, CMS, and FDA; presentations and discussions addressing activities of the Coordinating Council on the Clinical Laboratory Workforce; the National Institutes of Health Genetic Test Registry design and responses from testing laboratories; current testing practices and oversight of cytogenetic and cytogenomic testing; ongoing studies evaluating laboratory practices; and strategies for developing evidence-based methods for laboratory medicine quality improvement.

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: CLIAC accepts written comments until the date of the meeting (unless otherwise stated) for individuals or groups unable to attend the meeting. 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 and one hard copy with original signature should be provided to the contact person below. In addition, written comments will be included in the meeting's Summary Report.

Contact Person for Additional Information: Nancy Anderson, Chief, Laboratory Practice Standards Branch, Division of Laboratory Science and Standards, Laboratory Science, Policy and Practice Program Office (LSPPPO), Office of Surveillance, Epidemiology and Laboratory Services, CDC, 1600 Clifton Road, NE., Mailstop F-11, 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 the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Dated: January 25, 2011.

Elaine L. Baker,

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