[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 [email protected]. 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 [email protected]; 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
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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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.
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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