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