Published 60 Day FRN

19914

Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Notices

There are no costs to respondents
other than their time.

ESTIMATED ANNUALIZED BURDEN TO RESPONDENTS
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

State and Territorial Health Departments or Sexual Assault Coalition
Designee.

RPE–MIS: Initial population .............

55

1

15

825

RPE–MIS: Annual reporting .............

55

1

3

165

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

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

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

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

990

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

Leroy A. 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.

use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

[FR Doc. 2014–08012 Filed 4–9–14; 8:45 am]

Proposed Project

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0905]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

sroberts on DSK5SPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Type of respondents

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

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18:14 Apr 09, 2014

Jkt 232001

FoodNet Non-O157 Shiga ToxinProducing 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 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 nonO157 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

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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 nonoutbreak-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 nonO157 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 sciencebased 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.

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19915

Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name

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

Case questionnaire ..........................
Control questionnaire .......................

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ACF Program Instruction:
Children’s Justice Act.
OMB No.: 0970–0425.

Number of
responses per
respondent

Number of
respondents

Respondents

Average
burden
per response
(in hours)

Total

161
483

1
1

25/60
25/60

67
201

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

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

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

268

Description: The Program Instruction,
prepared in response to the enactment
of the Childrens Justice Act (CJA), Title
II of Public Law 111–320, Child Abuse
Prevention and Treatment Act
Reauthorization of 2010, provides
direction to the States and Territories to
accomplish the purposes of assisting
States in developing, establishing and
operating programs designed to
improve: (1) The assessment and
investigation of suspected child abuse
and neglect cases, including cases of
suspected child sexual abuse and
exploitation, in a manner that limits
additional trauma to the child and the
child’s family; (2) the assessment and
investigation of cases of suspected child
abuse-related fatalities and suspected
child neglect-related fatalities; (3) the
investigation and prosecution of cases of
child abuse and neglect, including child

sexual abuse and exploitation; and (4)
the assessment and investigation of
cases involving children with
disabilities or serious health-related
problems who are suspected victims of
child abuse or neglect. This Program
Instruction contains information
collection requirements that are found
in Public Law 111–320 at Sections
107(b) and 107(d), and pursuant to
receiving a grant award. The
information being collected is required
by statute to be submitted pursuant to
receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute; to monitor, evaluate and
measure grantee achievements in
addressing the investigation and
prosecution of child abuse and neglect;
and to report to Congress.
Respondents: State Governments.

ANNUAL BURDEN ESTIMATES
Instrument

Number of
respondents

Number of
responses per
respondent

Average
burden hours
per response

Total burden
hours

Application and Annual Report ........................................................................

52

1

60

3,120

Estimated Total Annual Burden
Hours: 3,120.
Additional Information

sroberts on DSK5SPTVN1PROD with NOTICES

Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 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. Email
address: [email protected].

information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–08065 Filed 4–9–14; 8:45 am]
BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0062]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exception From
General Requirements for Informed
Consent
AGENCY:

Food and Drug Administration,

HHS.
Notice.

OMB Comment

ACTION:

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

SUMMARY:

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The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of

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