[Federal Register Volume 71, Number 65 (Wednesday, April 5, 2006)]
[Notices]
[Pages 17103-17104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-06-0595]


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 404-639-5960 
and send comments to Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Performance Evaluation Program for Rapid HIV Testing (0920-0595)--
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 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. 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;

[[Page 17104]]

    (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. This 
questionnaire has a number of changes from the last OMB submission. In 
addition, participants are required to submit results twice/year after 
testing mailed performance evaluation samples. There is no cost to the 
respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                      Form                           Number of     Frequency of     burden per     Total burden
                                                    respondents      responses       response          hours
----------------------------------------------------------------------------------------------------------------
HIV Rapid Testing Questionnaire.................             750               1           20/60             250
HIV Rapid Testing Results Booklet...............             750               2           10/60             250
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             500
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    Dated: March 29, 2006.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-4919 Filed 4-4-06; 8:45 am]
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