Attachment 6 Preshipment Letter

Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-06-0600)

Proposed Data Collections Submitted for

Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 371-5983 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 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, Coordinating Center for Health Information and Service (COCHIS), Centers for Disease Control and Prevention.

Background and Brief Description:

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 heavy disease burden countries in the reduction of tuberculosis. 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 National Center for Health Marketing, Division of Laboratory Systems (DLS)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. 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 promote 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 costs to respondents other than their time.

The estimated annualized burden hours are 165.332.

Estimated Annualized Burden Hours

Type of Respondents	Form Name	No. of Respondents	No. of responses per Respondent	Average Burden per Response (in hours)
LaboratoriesU.S. and foreign)	Enrollment	2	1	(5/60) 0.0833
	Information change	2	1	(5/60) 0.0833
	Results Form	165	2	(30/60) 0.5

DATE:

____________________________

Joan F. Karr, Ph.D.

Acting Reports Clearance Officer

Centers for Disease Control and

Prevention

CERTIFIED TO BE A TRUE COPY OF THE

ORIGINAL

_______________________________________

Certifying Officer