[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)
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Patients...................... Case 161 1 25/60 67
questionnaire.
Controls...................... Control 483 1 25/60 201
questionnaire.
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.............. .............. .............. 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]
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