[Federal Register: August 12, 2004 (Volume 69, Number 155)]
[Notices]
[Page 49905-49906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au04-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-04-0274]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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) 498-1210 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Human
Resources and Housing Branch, New Executive Office Building, Room
10235, Washington, DC 20503 or by fax to (202) 395-6974. Written
comments should be received within 30 days of this notice.
Proposed Project
CDC Model Performance Evaluation Program (MPEP) for Retroviral and
AIDS-Related Testing, 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.
The burden is estimated to be approximately 1057 hours.
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Number of Average burden
Form name Number of responses per per response (in
respondents respondent hrs.)
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Enrollments (new)......................................... 100 1 3/60
HIV Testing Survey........................................ 1,000 1 * 1
CD4+ T-cell determinations Survey......................... 325 1 *30/60
HIV-1 Ab PE Results Form.................................. 900 2 10/60
HIV-1 RNA PE Results Form................................. 210 2 10/60
CD4+ T-cell determinations PE Results Form................ 300 2 10/60
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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 are divided by two.
[[Page 49906]]
Dated: August 5, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-18437 Filed 8-11-04; 8:45 am]
BILLING CODE 4163-18-P