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Agency Forms Undergoing Paperwork Reduction Act Review

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Information about this document as published in the Federal Register.

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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 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 Start Printed Page 66784rapid testing performance evaluation program (HIV Rapid Testing MPEP). This program offers external performance evaluation (PE) for rapid tests such as the OraQuick® 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®. 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

Form nameNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)
HIV Rapid Testing Laboratory Practices Questionnaire750130/60
HIV Rapid Testing Form EZ750210/60
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Dated: November 9, 2006.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.

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[FR Doc. E6-19369 Filed 11-15-06; 8:45 am]