[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22552-22553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08861]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-0600]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to [email protected]. Send written comments
to 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 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 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
[[Page 22553]]
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 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. The total estimated annual burden hours are 156.
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 tuberculosis 93 2 30/60
Results Worksheet.
Online Survey Instrument... 93 2 15/60
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Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-08861 Filed 4-15-13; 8:45 am]
BILLING CODE 4163-18-P