[Federal Register Volume 74, Number 116 (Thursday, June 18, 2009)]
[Notices]
[Pages 28939-28940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-09-0600]


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. 
Alternatively, to obtain a copy of the data collection plans and 
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, 
CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta, 
Georgia 30333; comments may also be sent by e-mail to [email protected].
    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 a 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 clarify 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 information technology. Written comments 
should be received within 60 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 
continue data collection from participants in 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 domestic clinical and public 
health laboratories and international laboratories. Data collection 
from domestic laboratory participants occurs twice per year. Data 
collection from international laboratories is limited to those that 
have public health responsibilities for tuberculosis drug 
susceptibility testing and have obtained approval to participate by 
their national tuberculosis program. 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.
    There is no cost to respondents to participate other than their 
time.

[[Page 28940]]



                                       Estimate of Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
             Form                  Respondents      respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Susceptibility Testing Results  Labs............             262               2           30/60             262
 Form.
Laboratory Practices            Labs............             132               1           30/60              66
 Questionnaire.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             328
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    Dated: June 11, 2009.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-14313 Filed 6-17-09; 8:45 am]
BILLING CODE 4163-18-P