[Federal Register Volume 74, Number 244 (Tuesday, December 22, 2009)]
[Notices]
[Pages 68066-68067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-10-0600]


Agency Forms Undergoing Paperwork Reduction Act Review

    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) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Model Performance Evaluation Program for Mycobacterium tuberculosis 
and Non-tuberculous Mycobacterium Drug Susceptibility Testing (OMB 
Control No. 0920-0600, expiration date 03/31/2010)--Revision--National 
Center for Preparedness, Detection, and Control of Infectious Diseases 
(NCPDCID), 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, CDC is 
requesting approval from the Office of Management and Budget to revise 
a currently approved data collection, the Model Performance Evaluation 
Program for Mycobacterium tuberculosis and Non-tuberculous 
Mycobacterium Drug Susceptibility Testing. This request includes 
changes to the Results Form and re-introduction of the Laboratory 
Practices Questionnaire.
    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 more than 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 Model 
Performance Evaluation Program for Mycobacterium tuberculosis and Non-
tuberculous Mycobacterium Drug Susceptibility Testing program supports 
this role by monitoring and evaluating the level of performance and 
practices among national and international laboratories performing M. 
tuberculosis susceptibility testing. Participation in this program is 
one way laboratories can ensure high-quality laboratory testing, 
resulting in accurate and reliable testing results.
    By providing an evaluation program to assess the ability of the 
laboratories to test for drug resistant M. tuberculosis and selected 
strains of Non-tuberculous Mycobacteria (NTM), laboratories also have a 
self-assessment tool to aid in optimizing their skills in 
susceptibility testing. The information obtained from laboratories on 
susceptibility testing practices and procedures is used to establish 
variables related to good performance, assessing training needs, and 
aid with the development of practice standards.
    Participants in this program include clinical and public health 
laboratories.

[[Page 68067]]

Participants register by submitting an Enrollment Form. Data collection 
from domestic laboratory participants occurs twice per year. The data 
collected in this program will include the susceptibility test results 
of primary and secondary drugs, drug concentrations, and test methods 
performed by laboratories on a set of performance evaluation (PE) 
samples. The PE samples are sent to participants twice a year. 
Participants also report demographic data such as laboratory type and 
the number of tests performed annually. Participants report this data 
every two years. The burden for the Laboratory Practices Questionnaire 
has been adjusted for the average per year, since responses are 
received every other year. Participants may submit changes about their 
laboratory using the Laboratory Information Change Form.
    There is no cost to respondents to participate other than their 
time. The total annualized burden for this information collection 
request is 166 hours.

                                       Estimate of Annualized Burden Hours
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                                                                                     Number of    Average burden
                 Form                          Respondents           Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Enrollment form.......................  Labs....................               4               1            5/60
Laboratory Change form................  Labs....................               4               1            5/60
Susceptibility Testing Results Form...  Labs....................             132               2           30/60
Laboratory Practices Questionnaire....  Labs....................              66               1           30/60
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    Dated: December 14, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E9-30339 Filed 12-21-09; 8:45 am]
BILLING CODE 4163-18-P