[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Pages 14164-14165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6520]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-10-0600]
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
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to [email protected]. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-5806.
Written comments should be received within 30 days of this notice.
Proposed Project
Model Performance Evaluation Program for Mycobacterium tuberculosis
and Non-tuberculous Mycobacterium Drug Susceptibility Testing (OMB
Control No. 0920-0600, expiration date 03/31/2010)--Revision--National
Center for Preparedness, Detection, and Control of Infectious Diseases
(NCPDCID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
As part of the continuing effort to support both domestic and
global 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 revise
a currently approved data collection, the Model Performance Evaluation
Program for Mycobacterium tuberculosis and Non-tuberculous
Mycobacterium Drug Susceptibility Testing. This request includes
changes to the Results Form and re-introduction of the Laboratory
Practices Questionnaire.
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. The rate of TB cases detected in foreign-born persons has been
reported to be more than nine times higher than the rate among the U.S.
born population. CDC's goal to eliminate TB will be virtually
impossible without considerable effort in assisting heavy disease
burden countries in the reduction of tuberculosis. The Model
Performance Evaluation Program for Mycobacterium tuberculosis and Non-
tuberculous Mycobacterium Drug Susceptibility Testing program supports
this role by monitoring and evaluating the level of performance and
practices among national and international 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 and selected
strains of Non-tuberculous Mycobacteria (NTM), laboratories also have a
self-assessment tool to aid in optimizing their skills in
susceptibility testing. The information obtained from laboratories on
susceptibility testing 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 clinical and public health
laboratories. Participants register by submitting an Enrollment Form.
Data collection from domestic 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.
Participants report this data every two years. The burden for the
Laboratory Practices Questionnaire has been adjusted for the average
per year, since responses are received every other year. Participants
may submit changes about their laboratory using the Laboratory
Information Change Form.
There is no cost to respondents to participate other than their
time. The total annualized burden for this information collection
request is 166 hours.
Estimate of Annualized Burden Hours
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Number of Average burden
Form Respondents Number of responses per per response
respondents respondent (in hours)
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Enrollment form....................... Labs.................... 4 1 5/60
Laboratory Change form................ Labs.................... 4 1 5/60
Susceptibility Testing Results Form... Labs.................... 132 2 30/60
Laboratory Practices Questionnaire.... Labs.................... 66 1 30/60
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[[Page 14165]]
Dated: March 17, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-6520 Filed 3-23-10; 8:45 am]
BILLING CODE 4163-18-P