Meetings: Clinical Laboratory Improvement Advisory Committee

Federal Register: August 8, 2008 (Volume 73, Number 154)

Notices

Page 46299

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr08au08-65

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Center for Preparedness, Detection, and Control of

Infectious Diseases

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 10, 2008; 8:30 a.m.-3 p.m., September 11, 2008.

Place: Centers for Disease Control and Prevention, 1600 Clifton

Road, NE., Tom Harkin Global Communications Center, Building 19,

Room 232, Auditorium B, Atlanta, Georgia 30333.

New Information--Online Registration Required: In order to expedite security clearance process at the CDC Roybal Campus located on Clifton Road, all CLIAC attendees are required to register in advance for the meeting at http://www.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 and submit your registration as far in advance of the meeting date as possible.

Note: The cut-off date for registration for domestic attendees is Thursday, September 4, 2008; the cut-off date for international attendees to register is Monday, August 25, 2008.

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; a report from the CLIAC Workgroup on Good

Laboratory Practices for Genetic Testing, and discussion of the

Workgroup's proposals related to such; presentations and discussion related to laboratory quality control through risk management; and an introduction to the status of waived testing and discussion of the potential for waiver of automated hematology devices. 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: Nancy Anderson,

Chief, Laboratory Practice Standards Branch, Division of Laboratory

Systems, National Center for Preparedness, Detection, and Control of

Infectious Diseases, Coordinating Center for Infectious Diseases,

CDC, 1600 Clifton Road, NE., Mailstop F-11, Atlanta, Georgia 30333; telephone (404) 498-2741; fax (404) 498-2219; or via e-mail at

Nancy.Anderson@cdc.hhs.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 CDC and the Agency for Toxic Substances and Disease

Registry.

Dated: July 28, 2008.

Elaine L. Baker,

Director, Management Analysis and Services Office, Centers for Disease

Control and Prevention.

FR Doc. E8-18285 Filed 8-7-08; 8:45 am

BILLING CODE 4163-18-P