[Federal Register Volume 68, Number 103 (Thursday, May 29, 2003)]
[Notices]
[Pages 32057-32058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-45-03]


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) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Performance Evaluation Program for Rapid HIV Testing--New--Public 
Health Practice Program Office (PHPPO), Centers for Disease Control and 
Prevention (CDC).
    To support our mission of improving public health and preventing 
disease through continuously improving laboratory practices, the Model 
Performance Evaluation Program (MPEP), Division of Laboratory Systems, 
Public Health Practice Program Office, Centers for Disease Control and 
Prevention intends to provide a new HIV rapid testing performance 
evaluation program (HIV Rapid Testing MPEP). This program will offer 
external performance evaluation (PE) for rapid tests such as the 
OraQuick[reg] Rapid HIV-1 Antibody Test, recently approved as a waived 
test by the U.S. Food and Drug Administration, and for other licensed 
tests such as the Abbott-Murex SUDS[reg] HIV-1 Test. Participation in 
PE programs is expected to lead to improved HIV testing performance 
because participants have the opportunity to identify areas for 
improvement in testing practices. This program will help to ensure 
accurate testing as a basis for development of HIV prevention and 
intervention strategies.
    This external quality assessment program will be made available at 
no cost (for receipt of sample panels) to

[[Page 32058]]

sites performing rapid testing for HIV antibodies. This program will 
offer laboratories/testing sites an opportunity for:
    (1) Assuring that the laboratories/testing sites are providing 
accurate tests through external quality assessment;
    (2) Improving testing quality through self-evaluation in a non-
regulatory environment;
    (3) Testing well characterized samples from a source outside the 
test kit manufacturer;
    (4) Discovering potential testing problems so that laboratories/
testing sites can adjust procedures to eliminate them;
    (5) Comparing individual laboratory/testing site results to others 
at a national and international level, and consulting with CDC staff to 
discuss testing issues.
    Participants in the MPEP HIV Rapid Testing program will be required 
to complete a laboratory practices questionnaire survey annually. In 
addition, participants will be required to submit results twice/year 
after testing mailed performance evaluation samples. The annual burden 
hours are estimated to be 175.

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                                                                                                  Average burden/
                              Forms                                   No. of       Frequency of    response (in
                                                                    respondents      responses        hours)
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HIV Rapid Testing Questionnaire.................................             300               1           15/60
HIV Rapid Testing Results Booklet...............................             300               2           10/60
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    Dated: May 21, 2003.
Thomas A. Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-13376 Filed 5-28-03; 8:45 am]
BILLING CODE 4163-18-P