[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
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Average
Number of Number of burden per Total burden
Respondents respondents responses per response (in (in hours)
respondent hours)
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Patients........................................ 161 1 25/60 67
Controls........................................ 483 1 25/60 201
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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]
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