05-16368. Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project

Model Performance Evaluation Program (MPEP), Severe Acute Respiratory Syndrome (SARS) MPEP OMB No. 0920-0680—Revision—Division of Laboratory Systems, Center for Health Information and Services (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 Public Health Partnerships, Coordinating Center for Health Information and Services, in collaboration with the Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, intends to provide a new SARS-associated Coronavirus testing Model Performance Evaluation Program (SARS MPEP). This program will offer external performance evaluation (PE) for SARS antibody (Ab) testing and SARS Ribonucleic Acid (RNA) Reverse Transcriptase—Polymerase Chain Reaction (RT-PCR) testing. A SARS outbreak or epidemic could recur at any time. Therefore, it is imperative that the CDC ensure all state public health department laboratories, Laboratory Response Network laboratories and other laboratories designated by CDC remain proficient in performing SARS testing. For this reason, it is of critical public health importance at this time, that the CDC develop and maintain a performance evaluation program for SARS. Participation in PE programs is expected to lead to improved SARS testing performance because participants have the opportunity to identify areas for improvement which will help to ensure accurate testing as a basis for development of SARS prevention and intervention strategies.

This external quality assessment program will be made available at no cost (for receipt of sample panels) to 54 state laboratories. This program will offer laboratories/testing sites opportunities 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 state level, and

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

Participants in the MPEP SARS will be required to submit results twice a year after testing mailed performance evaluation samples.

There are no costs to the respondents other than their time. The total estimated annualized burden hours are 18.

Estimated Annualized Burden Hours

Form name	No. of respondents	Frequency of responses	Average burden per response (in hours)
SARS Testing Results Booklet	54	2	10/60

Dated: August 11, 2005.

Joan F. Karr,

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