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