[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6862-6863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0600]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to <a href="/cdn-cgi/l/email-protection#bbd4d6d9fbd8dfd895dcd4cd"><span class="__cf_email__" data-cfemail="c2adafa082a1a6a1eca5adb4">[email protected]</span></a>. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis Drug Susceptibility Testing (OMB Control No. 0920-0600, 
Expires 5/31/2016)--Extension--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 for 
an extension of three years from the Office of Management and Budget to 
continue information collection from participants in the Model 
Performance Evaluation Program for Mycobacterium Tuberculosis 
Susceptibility Testing. Extension of this information collection will 
not require changes in the scope of the study, methodology, information 
collection instruments, or burden on the respondents.
    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 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.
    Extension of this information collection provides CDC with an

[[Page 6863]]

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 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
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory...................  Participant Biosafety                 93               2            5/60
                                         Compliance Letter of
                                         Agreement.
                                        MPEP Mycobacterium                    93               2           30/60
                                         tuberculosis Results
                                         Worksheet.
                                        Online Survey Instrument              93               2           15/60
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-02519 Filed 2-8-16; 8:45 am]
 BILLING CODE 4163-18-P


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