Attachment 4 - 60 day FRN

60 day ecoli.pdf

FoodNet Non-0157 Shiga Toxin-Producing E.coli Study: Assessment of Risk Factors for Laboratory-Confirmed Infections and Characterization of Illnesses by Microbiological Characteristics

Attachment 4 - 60 day FRN

OMB: 0920-0905

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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
FOR FURTHER INFORMATION CONTACT:

Brian Chiglinsky, 202–260–6090. Press
inquiries are handled through OCIIO’s
Press Office at (202) 690–6343.
SUPPLEMENTARY INFORMATION:

emcdonald on DSK2BSOYB1PROD with NOTICES

I. Background
The purpose of the meeting is to assist
and advise the Secretary and Congress
through the Department of Health and
Human Services’ Office of Consumer
Information and Insurance Oversight
(OCIIO) on the Department’s strategy to
foster the creation of qualified nonprofit
health insurance issuers. Specifically,
the Committee shall advise the
Secretary and Congress concerning the
award of grants and loans related to
Section 1322 of the Affordable Care Act.
In these matters, the Committee shall
consult with all components of the
Department, other federal entities, and
non-federal organizations, as
appropriate; and examine relevant data
sources to assess the grant and loan
award strategy to provide
recommendations to OCIIO.
II. Meeting Agenda
The committee will hear testimony
from a number of individuals with
experience and expertise in the market
for health insurance and nonprofit
cooperative health issuers. OCIIO
intends to make background material
available to the public no later than two
(2) business days prior to the meeting.
If OCIIO is unable to post the
background material on its Web site
prior to the meeting, it will be made
publicly available at the location of the
advisory committee meeting, and the
background material will be posted on
OCIIO’s Web site after the meeting, at
http://hhs.gov/ociio.
Oral comments from the public will
be scheduled between approximately
3 p.m. to 4 p.m. Individuals or
organizations that wish to make a
3-minute oral presentation on an agenda
topic should submit a written copy of
the oral presentation to the DFO at the
address listed in the ADDRESSES section
of this notice by the date listed in the
DATES section of this notice. The
number of oral presentations may be
limited by the time available. Persons
attending OCIIO’s advisory committee
meetings are advised that the agency is
not responsible for providing access to
electrical outlets. If the number of
speakers requesting to comment is
greater than can be reasonably
accommodated during the scheduled
open public comment session, OCIIO
will take written comments after the
meeting until close of business.
Individuals not wishing to make a
presentation may submit written

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comments to the DFO at the address
listed in the ADDRESSES section of this
notice by the date listed in the DATES
section of this notice.
Individuals requiring sign language
interpretation or other special
accommodations must contact the DFO
via the contact information specified in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date listed
in the DATES section of this notice.
OCIIO is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
http://www.hhs.gov/ociio for procedures
on public conduct during advisory
committee meetings.
Dated: December 21, 2010.
Barbara Smith,
Associate Director, Consumer Operated and
Oriented Plan Program, Office of Consumer
Information and Insurance Oversight.
[FR Doc. 2010–32649 Filed 12–27–10; 8:45 am]
BILLING CODE 4150–45–P

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

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technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
FoodNet Non-O157 Shiga ToxinProducing 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 toxinproducing 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 nonO157 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 casecontrol 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 nonO157 STEC to assess how risk factors
and clinical features vary by virulence
factor profiles. As the largest, most
comprehensive, and most powerful

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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices

study of its kind, it could make an
important contribution towards better
understanding of non-O157 STEC
infections and to providing sciencebased 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
Number of
respondents

Respondents

Number of
responses per
respondent

Average
burden per
response (in
hours)

Total burden
(in hours)

Patients ............................................................................................................
Controls ............................................................................................................

161
483

1
1

25/60
25/60

67
201

Total ..........................................................................................................

........................

........................

........................

268

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]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Office of Community Services
(OCS) Community Economic
Development (CED) and Job
Opportunities for Low-Income
Individuals (JOLI) Standard Reporting
Format.
OMB No.: New Collection.

Description: The Office of Community
Services (OCS) is collecting key
information about projects funded
through the Community Economic
Development (CED) and Job
Opportunities for Low-Income
Individuals (JOLI) programs. The
legislative requirement for these two
programs is in Title IV of the
Community Opportunities,
Accountability and Training and
Educational Services Act (COATS
Human Services Reauthorization Act) of
October 27, 1998, Public Law 105–285,
section 680(b) as amended. The
Performance Progress Report (PPR) is a
new proposed reporting format that will
collect information concerning the
outcomes and management of CED and
JOLI projects. OCS will use the data to
critically review the overall design and
effectiveness of each program.
The PPR will be administered to all
active grantees of the CED and JOLI

programs. Grantees will be required to
use this reporting tool for their
semiannual reports. The majority of the
questions in this tool were adapted from
a previously approved questionnaire,
Office of Management and Budget
(OMB) Control Number: 0970–0317.
Questions were also adapted to the
OMB-approved reporting format of the
PPR, specifically forms SF–PPR, SF–
PPR–A, SF–PPR–B, and SF–PPR–E.
Additional changes were made to
improve the clarity and quality of the
data and to eliminate unnecessary
questions. The PPR will replace both the
annual questionnaire and the current
semi-annual reporting format, which
will result in an overall reduction in
burden for the grantees while
significantly improving the quality of
the data collected by OCS.
Respondents: Current CED and JOLI
grantees.

emcdonald on DSK2BSOYB1PROD with NOTICES

TABLE 1—ANNUAL BURDEN ESTIMATE
Instrument

Number of
responses

Number of
responses per
respondent

Average
burden hours
per
response

PPR Forms for current OCS JOLI grantees ....................................................
PPR Forms for current OCS CED grantees ....................................................
Estimated Annual Burden Hours .....................................................................

40
170
........................

2
2
........................

1.5
1.5
........................

Estimated Total Annual Burden
Hours: 630.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
[email protected].

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OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax: 202–

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Total burden
hours
120
510
630

395–7285, E-mail:
[email protected],
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: December 21, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–32509 Filed 12–27–10; 8:45 am]
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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2010-12-28
File Created2010-12-28

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