E6-7002. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Performance Evaluation Program for Mycobacterium Tuberculosis and Non-Tuberculous Mycobacterium (NTM) Drug Susceptibility Testing (0920-0600)—Extension—National Center for Health Marketing (NCHM), Coordinating Center for Health Information and Service (CoCHIS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

As part of the continuing effort to support both domestic and global public health objectives for treatment of tuberculosis (TB), prevention of multi-drug resistance and surveillance programs, the Division of Laboratory Systems seeks to continue to collect information from domestic private clinical and public health laboratories twice per year. Participation and information collections from international laboratories are limited to those which have public health responsibilities for tuberculosis drug susceptibility testing and approval by their national tuberculosis program. While the overall number of cases of TB in the U.S. has decreased, rates still remain high among foreign-born persons, prisoners, homeless populations, and individuals infected with HIV in major metropolitan areas. The rate of TB cases detected in foreign-born persons has been reported to be almost nine times higher than the rate among the U.S. born population.

CDC's goal to eliminate TB will be virtually impossible without considerable effort in assisting countries with heavy disease burden in the reduction of tuberculosis. The M.tuberculosis/NTM program supports this role by monitoring the level of performance and practices among laboratories performing M. tuberculosis susceptibility within the U.S, as well as internationally, to ensure high-quality laboratory testing, resulting in accurate and reliable results.

Information collected in this program includes the susceptibility test results of primary and secondary drugs, concentrations, and test methods performed by laboratories on a set of challenge isolates sent twice yearly. A portion of the response instrument collects demographic data such as laboratory type and the number of tests performed annually. By providing an evaluation program to assess the ability of the laboratories to test for drug resistant M. tuberculosis and selected strains of NTM, laboratories have a self-assessment tool to aid in maximizing their skills in susceptibility testing. Information obtained from laboratories on susceptibility testing practices and procedures assists with determining variables related to good performance, with assessing areas for training and with developing practice standards.

There are no cost to the respondents other than their time.

Estimated Annualized Burden Hours

Respondents	No. of respondents	Average number of responses per respondent	Average burden per response (in hours)	Total burden hours
Domestic Private/Public Laboratories	165	1	30/60	83
International Laboratories (with public health responsibilities)	165	1	30/60	83
Total				166

Dated: May 1, 2006.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.