E9-29967. 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] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Performance Evaluation Program for HIV Rapid Testing (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). 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. In addition, with this request, CDC is adding an Enrollment Form for new participants and an Information Change Form to enable participants to update current contact information. 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. The total annualized burden for this data collection is 387 hours.

Estimated Annualized Burden Hours

Form	Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
HIV Rapid Testing Results Form	Labs	660	2	10/60
HIV Rapid Testing Questionnaire	Labs	330	1	30/60
Enrollment Form	Labs	10	1	3/60
Information Change Form	Labs	20	1	3/60

Dated: December 9, 2009.

Maryam I. Daneshvar,

Acting Reports Clearance Officer Centers for Disease Control and Prevention.