[Federal Register: June 18, 2009 (Volume 74, Number 116)]
[Notices]
[Page 28939-28940]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn09-32]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-09-0600]
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.
Alternatively, to obtain a copy of the data collection plans and
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar,
CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta,
Georgia 30333; comments may also be sent by e-mail to omb@cdc.gov.
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 a 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 clarify 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 information technology. Written comments
should be received within 60 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
continue data collection from participants in 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 domestic clinical and public
health laboratories and international laboratories. Data collection
from domestic laboratory participants occurs twice per year. Data
collection from international laboratories is limited to those that
have public health responsibilities for tuberculosis drug
susceptibility testing and have obtained approval to participate by
their national tuberculosis program. 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.
There is no cost to respondents to participate other than their
time.
[[Page 28940]]
Estimate of Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Form Respondents respondents responses per response (in (in hours)
respondent hours)
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Susceptibility Testing Results Labs............ 262 2 30/60 262
Form.
Laboratory Practices Labs............ 132 1 30/60 66
Questionnaire.
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Total..................... ................ .............. .............. .............. 328
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Dated: June 11, 2009.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-14313 Filed 6-17-09; 8:45 am]
BILLING CODE 4163-18-P