[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81613-81614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-11BI]


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 404-639-5960 
and send comments to Carol Walker, Acting CDC Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    FoodNet Non-O157 Shiga Toxin-Producing E. coli Study: Assessment of 
Risk Factors for Laboratory-Confirmed Infections and Characterization 
of Illnesses by Microbiological Characteristics--New--National Center 
for Emerging and Zoonotic Infectious Diseases, Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Each year many Shiga toxin-producing E. coli (STEC) infections 
occur in the United States, ranging in severity from mild diarrhea, to 
hemorrhagic colitis and in some cases, life-threatening hemolytic 
uremic syndrome (HUS). HUS occurs most frequently following infection 
with serogroup O157; 6% of patients with this type of STEC infection 
develop HUS, with highest occurrence in children aged <5 years. HUS has 
a fatality rate of approximately 5%; up to 25% of HUS survivors are 
left with chronic kidney damage.
    STEC are broadly categorized into two groups by their O antigens, 
STEC O157 and non-O157 STEC. The serogroup O157 is most frequently 
isolated and most strongly associated with HUS. Risk factors for STEC 
O157 infections in the United States and internationally have been 
intensely studied. Non-O157 STEC are a diverse group that includes all 
Shiga toxin-producing E. coli of serogroups other than O157. Over 50 
STEC serogroups are known to have caused human illness. Numerous non-
O157 outbreaks have been reported from throughout the world and 
clinical outcomes in some patients can be as severe as those seen with 
STEC O157 infections, however, little is known about the specific risk 
factors for infections due to non-O157 STEC serogroups. More 
comprehensive understanding of risk factors for sporadic non-O157 STEC 
infections is needed to inform prevention and control efforts. The 
FoodNet case-control study will be the first multistate investigation 
of non-outbreak-associated non-O157 STEC infections in the United 
States. It will investigate risk factors for non-O157 STEC infections, 
both as a group and individually for the most common non-O157 STEC 
serogroups. In addition, the study will characterize the major known 
virulence factors of non-O157 STEC to assess how risk factors and 
clinical features vary by virulence factor profiles. As the largest, 
most comprehensive, and most powerful

[[Page 81614]]

study of its kind, it could make an important contribution towards 
better understanding of non-O157 STEC infections and to providing 
science-based recommendations for interventions to prevent these 
infections.
    Persons with non-O157 STEC infections who are identified as part of 
routine public health surveillance and randomly selected healthy 
persons in the patients' communities (to serve as controls) will be 
contacted and offered enrollment into this study. Participation is 
completely voluntary and there is no cost for enrollment.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                   Respondents                      respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Patients........................................             161               1           25/60              67
Controls........................................             483               1           25/60             201
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             268
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    Dated: December 21, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-32588 Filed 12-27-10; 8:45 am]
BILLING CODE 4163-18-P