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