[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35165-35166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-14-0905]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the

[[Page 35166]]

burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (c) Enhance the 
quality, utility, and clarity of the information to be collected; (d) 
Minimize the burden of the collection of information on those who are 
to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses; and (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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 (OMB No. 0920-0905, 
expires 11/30/14)--Extension--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 is 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 is the first multistate 
investigation of non-outbreak-associated non-O157 STEC infections in 
the United States. It investigates 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 characterizes 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 is making 
an important contribution towards better understanding of non-O157 STEC 
infections and will provide science-based recommendations for 
interventions to prevent these infections.
    Study enrollment began between July and September 2012 (sites had 
staggered start dates) and is scheduled to run for 36 months. Since we 
have not yet enrolled enough cases to meet the study objectives, we are 
requesting an extension.
    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) are 
contacted and offered enrollment into this study. Participation is 
completely voluntary and there is no cost for enrollment. The estimated 
annual burden is 268 hours.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent         hrs.)
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Patients..............................  Case questionnaire......             161               1           25/60
Controls..............................  Control questionnaire...             483               1           25/60
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Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-14331 Filed 6-18-14; 8:45 am]
BILLING CODE 4163-18-P