E7-13605. 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

CDC Model Performance Evaluation Program (MPEP) (0920-0274)—Revision—National Center for Preparedness, Detection, and Control of Infectious Diseases (proposed) (NCPDCID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is requesting OMB approval of a revision to its data collection, the CDC Model Performance Evaluation Program (MPEP). CDC originally implemented MPEP in 1986 to evaluate the performance of laboratories conducting testing to detect human immunodeficiency virus type 1 (HIV-1) antibody (Ab). CDC is requesting a 3-year approval for this data collection.

In this program, respondents receive 2 shipments of specimens per year. Respondents test the specimens in their laboratory/testing site and report their results either using a report booklet or on-line. CDC provides the respondent with a report containing the analysis of the laboratory test results reported to CDC. Participation in this program is voluntary and provides the respondents an opportunity to (1) assure accurate tests are being provided by the laboratory/testing site through external quality assessment; (2) improve testing quality through self-evaluation in a non-regulatory environment; (3) test well characterized samples from a source outside the test kit manufacturer; (4) discover potential testing problems so that procedures can be adjusted to eliminate them; (5) compare of testing results with others at a national and international level; and (6) consult with CDC staff to discuss testing issues.

In this request, CDC proposes to make the following revisions to the currently approved data collection:

• Addition of a Name and Address change form to report changes for the MPEP manager and coordinator at the respondent laboratory;
• Inclusion of additional test kit manufacturers approved by the FDA since previous OMB approval; and
• Elimination of reporting HIV-1 RNA Viral Load and CD4+ T-cell determinations.

There are no costs to the respondents other than their time to complete the survey. The total estimated annualized burden hours are 257.

Total Estimated Annualized Burden Hours

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
New Enrollees	100	1	3/60
Laboratory Change Form	20	1	3/60
Laboratory Test Result Form	754	2	10/60

Dated: July 9, 2007.

Maryam Daneshvar,

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