[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66270-66271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-0600]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled CDC Model Performance Evaluation Program 
(MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing to 
the Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on August 28, 2018 to obtain 
comments from the public and affected agencies. CDC received one non-
substantive anonymous comment related to the previous notice. This 
notice serves to allow an additional 30 days for public and affected 
agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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#6b0406092b080f08450c041d"><span class="__cf_email__" data-cfemail="d9b6b4bb99babdbaf7beb6af">[email protected]</span></a>. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis Drug Susceptibility Testing (OMB Control No.0920-0600, 
Expires 3/31/2019)--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

[[Page 66271]]

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 information collection 
from participants in the Model Performance Evaluation Program for 
Mycobacterium tuberculosis Susceptibility Testing. This revision 
request includes (a) modification of the Participant Biosafety 
Compliance Letter of Agreement to contain language to ensure that 
participants understand and comply with biosafety guidelines using 
quality management system practices; (b) modification of Instructions 
to Participants Letter to include detailed instructions for online data 
entry of DST results; (c) modification of MPEP Mycobacterium 
tuberculosis Results Worksheet to include fields for entering methods 
used for conventional and molecular DST; (d)addition of a MPEP 
Mycobacterium tuberculosis Minimum Inhibitory Concentration (MIC) 
Results form for laboratories performing this procedure to enter 
results manually and submit by email to <a href="/cdn-cgi/l/email-protection#792d3b34293c29391a1d1a571e160f"><span class="__cf_email__" data-cfemail="74203639243124341710175a131b02">[email protected]</span></a>; and (e) 
reduction in request for burden hours from 156 hours to 129 hours due 
to fewer laboratories participating in the program compared to the 
previous submission request.
    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.
    Revision of this information collection provides CDC with 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 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. Total burden hours is 129.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratories.................  Participant Biosafety                 80               1            5/60
                                         Compliance Letter of
                                         Agreement.
                                        MPEP Mycobacterium                    80               2           30/60
                                         tuberculosis Results
                                         Worksheet.
                                        Online Survey Instrument              80               2           15/60
                                        Minimum Inhibitory                     4               2           15/60
                                         Concentration (MIC)
                                         Results Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-27853 Filed 12-21-18; 8:45 am]
 BILLING CODE 4163-18-P


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