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. Alternatively, to obtain a copy of the data collection plans and instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30333; comments may also be sent by e-mail to omb@cdc.gov.

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 clarify 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 information technology. Written comments should be received within 60 days of this notice.

Proposed Project

The Model Performance Evaluation Program for HIV Rapid Testing (MPEP HIV-RT) (OMB Control No. 0920-0595, expiration date 3/31/2010)—Revision—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC).

Brief Description and Background

To support CDC's mission of improving public health and preventing disease through continuously improving laboratory practices, CDC is requesting approval from the Office of Management and Budget (OMB) to continue data collection activities of the HIV rapid testing performance evaluation program (MPEP HIV RT) and to make changes to the results form.

This program offers external performance evaluation (PE) twice a year for rapid HIV tests approved by the U.S. Food and Drug Administration (FDA). Examples of such tests are the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, the Uni-Gold Recombigen HIV test, the Clearview HIV 1/2 STAT-PAK, the Clearview COMPLETE HIV 1/2, and the MedMira Reveal G3 Rapid HIV-1 Antibody 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 their testing practices. This program helps to ensure accurate HIV rapid testing which is the foundation for HIV prevention and intervention programs.

This program offers laboratories/testing sites opportunities for:

(1) Assuring that the laboratories/testing sites are providing accurate test results 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 reduce and eliminate errors

(5) Comparing individual laboratory/testing site results to others at the national and international level, and

(6) Consulting with CDC staff to discuss testing issues.

Program participants receive PE samples twice each year and report testing results to CDC. In addition to conducting the performance evaluation, participants in the MPEP HIV Rapid Testing program are required to complete a biennial (every other year) laboratory practices questionnaire. The burden for the Laboratory Practices Questionnaire has been adjusted for the average per year, since respondents complete the survey every two years. CDC does not charge any fees to sites participating in this external quality assessment program.

There is no cost to respondents to participate in this program.