[Federal Register: November 16, 2006 (Volume 71, Number 221)]
[Notices]
[Page 66783-66784]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no06-78]
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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 omb@cdc.gov. 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)
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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