03-13376. 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 [phone]. 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® 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® 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 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.

Forms	No. of respondents	Frequency of responses	Average burden/response (in hours)
HIV Rapid Testing Questionnaire	300	1	15/60
HIV Rapid Testing Results Booklet	300	2	10/60

Dated: May 21, 2003.

Thomas A. Bartenfeld,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.