[Federal Register Volume 71, Number 221 (Thursday, November 16, 2006)]
[Notices]
[Pages 66783-66784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-07-0595]


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) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Performance Evaluation Program for Rapid HIV Testing--Revision--
National Center for Health Marketing (NCHM), Coordinating Center for 
Health Information and Service (CoCHIS), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    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, 
Coordinating Center for Health Information and Service, Centers for 
Disease Control and Prevention intends to continue the currently 
ongoing HIV

[[Page 66784]]

rapid testing performance evaluation program (HIV Rapid Testing MPEP). 
This program offers external performance evaluation (PE) for rapid 
tests such as the OraQuick[supreg] Rapid HIV-1 Antibody Test, approved 
as a waived test by the U.S. Food and Drug Administration, and for 
other licensed tests such as the MedMira Reveal[supreg]. 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. Participants include facilities and 
testing sites that perform HIV Rapid Testing. This program helps to 
ensure accurate testing as a basis for development of HIV prevention 
and intervention strategies.
    This external quality assessment program is made available at no 
cost (for receipt of sample panels) to sites performing rapid testing 
for HIV antibodies. This program offers 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 
nonregulatory 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
    (6) Consulting with CDC staff to discuss testing issues.
    Participants in the MPEP HIV Rapid Testing program are required to 
complete a laboratory practices questionnaire survey annually. In 
addition, participants are required to submit results twice/year after 
testing mailed performance evaluation samples. There is no cost to 
respondents other than their time. The estimated annualized burden is 
625.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
                            Form name                               respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
HIV Rapid Testing Laboratory Practices Questionnaire............             750               1           30/60
HIV Rapid Testing Form EZ.......................................             750               2           10/60
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    Dated: November 9, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E6-19369 Filed 11-15-06; 8:45 am]
BILLING CODE 4163-18-P