[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28893-28894]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-50]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-04-52]
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 the CDC Reports
Clearance Officer on (404) 498-1210.
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. Send comments to Dale Verell, CDC
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-E11,
Atlanta, GA 30333. Written comments should be received within 60 days
of this notice.
Proposed Project
CDC Model Performance Evaluation Program, OMB No. 0920-0274--
Revision--Public Health Practice Program Office (PHPPO), Centers for
Disease Control and Prevention (CDC).
In 1986, the Centers for Disease Control and Prevention (CDC)
implemented the Model Performance Evaluation Program (MPEP) to evaluate
the performance of laboratories conducting testing to detect human
immunodeficiency virus type 1 (HIV-1) antibody (Ab), and to support
CDC's mission of improving public health and preventing disease through
continuously improving laboratory practices.
High-quality HIV-1 antibody testing is essential to meeting the
public health objectives for the prevention and control of this
retrovirus infection. High-quality CD4+ T-cell determinations and HIV-1
viral RNA (viral load) determinations are essential to HIV-infected
patient care and management, and the mission of reducing retrovirus-
associated morbidity and mortality. Prevention programs, diagnostic
clinics, and seroprevalence studies rely not only on accurate antibody
testing results to document HIV infection but also accurate CD4+ T-cell
determinations and HIV-1 viral RNA determinations. The impetus for
developing this program came from the recognized need to assess the
quality of retroviral and AIDS-related laboratory testing and to ensure
that the quality of testing was adequate to meet medical and public
health needs. The objectives of the MPEP are to: (1) Develop
appropriate methods for evaluating quality in laboratory testing
systems (including test selection, sample collection, and reporting and
interpreting test results); (2) develop strategies for identifying and
correcting testing quality failures; and (3) evaluate the effect of
testing quality on public health.
This external quality assessment program will be made available at
no cost (for receipt of sample panels) to sites conducting testing to
detect human immunodeficiency virus type 1 (HIV-1) antibody (Ab), CD4+
T-cell determinations, and HIV-1 viral RNA determinations. This program
will offer laboratories/testing sites an opportunity for:
Assuring accurate tests are being provided by the
laboratory/testing site through external quality assessment;
Improving testing quality through self-evaluation in a
non-regulatory environment;
Testing well characterized samples from a source outside
the test kit manufacturer;
Discovering potential testing problems so that procedures
can be adjusted to eliminate them;
Comparison of testing results with others at a national
and international level; and
Ability to consult with CDC staff to discuss testing
issues.
There are no costs to respondents.
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Numbers of Average burden
Form name Number of response per per response Total burden
respondents respondent (in hrs.) (in hrs.)
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Enrollments (new)............................... 100 1 3/60 5
HIV Testing Survey.............................. 1,000 1 1 333*
CD4+ T-cell determinations Survey............... 325 1 30/60 54*
HIV-1 Ab PE Results Form........................ 900 2 10/60 300
HIV-1 RNA PE Results Form....................... 210 2 10/60 70
CD4+ T-cell determinations PE Results Form...... 300 2 10/60 100
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Totals...................................... .............. .............. .............. 862
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* Both the HIV and the CD4+ T-cell determinations surveys are performed every other year; therefore, the total
hour burden for these two surveys was divided by three to determine annualized hourly burden for the three-
year approval period.
[[Page 28894]]
Dated: May 13, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-11277 Filed 5-18-04; 8:45 am]
BILLING CODE 4163-18-P