[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19914-19915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0905]


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 404-639-7570 or 
send comments to Leroy Richardson 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email 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 (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 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 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 total 
burden is 268 hours.

[[Page 19915]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
          Respondents               Form name        Number of     responses per   per response        Total
                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Patients......................  Case                         161               1           25/60              67
                                 questionnaire.
Controls......................  Control                      483               1           25/60             201
                                 questionnaire.
                                                 ---------------------------------------------------------------
                                                  ..............  ..............  ..............             268
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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. 2014-08014 Filed 4-9-14; 8:45 am]
BILLING CODE 4163-18-P