[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4148-4149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-0600]


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. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email 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 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

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility 
Testing OMB 0920-0600 (exp. 5/31/2013),--Revision--National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    As part of the continuing effort to support domestic 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 revision request includes (a) Changing the 
title of the data collection to ``CDC Model Performance Evaluation 
(MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing'' to 
reflect that nontuberculous mycobacteria are no longer included in the 
test package; (b) replacement of Laboratory Enrollment Form with a 
Participant Biosafety Compliance Letter of Agreement; (c) revision of 
the Pre-shipment Email; (d) addition of Instructions to Participants 
Letter; (e) revision of the MPEP M. tuberculosis Results Worksheet; (f) 
entering survey results online using a modified data collection 
instrument; (g) modification of Reminder Email; (h) modification of 
Reminder Telephone Script; and (i) modification of the Aggregate Report 
Letter.
    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. To reach the goal of eliminating TB, the Model Performance 
Evaluation Program for Mycobacterium tuberculosis and Non-tuberculous 
Mycobacterium Drug Susceptibility Testing is used to monitor and 
evaluate performance and practices among national 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 strains, 
laboratories also have a self-assessment tool to aid in optimizing 
their skills in susceptibility testing. The information obtained from 
the laboratories on susceptibility 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. Data collection from laboratory participants 
occurs twice per

[[Page 4149]]

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.
    There is no cost to respondents to participate other than their 
time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
     Type of  respondent           Form name        respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory..........  Participant                    93               2            5/60              16
                                Biosafety
                                Compliance
                                Letter of
                                Agreement.
                               MPEP                           93               2           30/60              93
                                Mycobacterium
                                tuberculosis
                                Results
                                Worksheet.
                               Online Survey                  93               2           15/60              47
                                Instrument.
                                                 ---------------------------------------------------------------
    Total....................  .................  ..............               0  ..............             156
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    Dated: January 14, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-00988 Filed 1-17-13; 8:45 am]
BILLING CODE 4163-18-P