[Federal Register Volume 68, Number 148 (Friday, August 1, 2003)]
[Notices]
[Pages 45243-45244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19578]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-58-03]


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) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 days 
of this notice.
    Proposed Project: Centers for Disease Control and Prevention's 
Performance Evaluation Program for Mycobacterium Tuberculosis and Non-
Tuberculosis Mycobacterium (NTM) Drug Susceptibility Testing--New--
Public Health Practice Program Office (PHPPO), Centers for Disease 
Control and Prevention (CDC).
    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 collect information from 
domestic private clinical and public health laboratories twice per 
year. Participation and information collections from international 
laboratories will be 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 heavy disease burden countries 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 will include 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 will collect 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 will also have a self-assessment tool to 
aid in maximizing their skills in susceptibility testing. Information 
obtained from laboratories on susceptibility testing practices and 
procedures will assist with determining variables related to good 
performance, with assessing areas for training and with developing 
practice standards. There are no costs to respondents.

----------------------------------------------------------------------------------------------------------------
                                                                                   Number of     Average  burden
                         Respondents                              Number of      responses per    per  response
                                                                 respondents       respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
Private Clinical and Public Health Laboratories..............             165                2            30/60
----------------------------------------------------------------------------------------------------------------



[[Page 45244]]

    Dated: July 24, 2003.
Laura Y. Martin,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-19578 Filed 7-31-03; 8:45 am]
BILLING CODE 4163-18-P