[Federal Register Volume 69, Number 235 (Wednesday, December 8, 2004)]
[Notices]
[Pages 71059-71060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[7Day-05-AN]


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

[[Page 71060]]

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.

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                                                                      No. of      Average burden
                    Form name                         No. of       responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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SARS Testing Results Booklet....................              54               1           10/60               9
    Total.......................................  ..............  ..............  ..............               9
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    Dated: December 2, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-26914 Filed 12-7-04; 8:45 am]
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