[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Pages 13191-13192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-11-11BI]


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 (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 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 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. The total 
estimated annualized burden is 268 hours.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
                           Respondents                               Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Patients........................................................             161               1           25/60
Controls........................................................             483               1           25/60
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[[Page 13192]]

Catina Conner,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevent.
[FR Doc. 2011-5460 Filed 3-9-11; 8:45 am]
BILLING CODE 4163-18-P