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. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer at (404) 498-1210. CDC is requesting an emergency clearance for this data collection with a seven-day public comment period. CDC is requesting OMB approval of this package seven days after the end of the public comment period.

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 clarity 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 automated collection techniques or other forms of information technology. As this is an emergency clearance, please direct comments to the CDC Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 395-6974. Comments should be received within seven days of this notice.

Proposed Project: Performance Evaluation Program for Severe Acute Respiratory Syndrome Antibody (SARS Ab) Testing—New—Public Health Practice Program Office (PHPPO), Centers for Disease Control and Prevention (CDC).

Great attention has been focused on SARS which is a viral respiratory illness caused by a coronavirus, called SARS-associated coronavirus (SARS-CoV). SARS was first reported in Asia in February 2003. Over the next few months, the illness spread to more than two dozen countries in North America, South America, Europe, and Asia before the SARS global outbreak of 2003 was contained.

The SARS virus has recently been shown to be endemic in some populations, and as the season most conducive for SARS infection approaches, the possibility for an outbreak or epidemic exists. Therefore, it is imperative that the CDC ensure all State Public Health 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.

CDC, through the Model Performance Evaluation Program (MPEP), intends to provide a new SARS-CoV testing performance evaluation program (SARS MPEP). This program will offer external performance evaluation for SARS Ab testing. Participation in the performance evaluation program is expected to lead to improved SARS testing performance because participants have the opportunity to identify areas for improvement. This will help 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. Participants in the SARS MPEP will be required to submit results twice a year after testing mailed performance evaluation samples. Since SARS testing methods may change due to research and development conducted by CDC and potentially (in the future) by commercial kit manufacturers, CDC will collect the SARS Sample Result Surveys (SRS) information biannually. Further, since laboratories are not continuously testing for SARS, it is necessary to offer a performance evaluation challenge at least biannually so that the labs maintain sufficient proficiency to allow quick response to an outbreak.

CDC is requesting emergency approval to conduct the samples survey for six months while the complete information collection is being processed for clearance and approval. During this six-month period, approximately 54 states will be asked to participate on a one-time basis. There are no costs to respondents other than their time in processing the samples.