Proposed Data Collections Submitted for Public Comment and Recommendations, 19914-19915 [2014-08014]
Download as PDF
<![CDATA[
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
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
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
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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0905]
sroberts on DSK5SPTVN1PROD with NOTICES
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 omb@cdc.gov.
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
VerDate Mar<15>2010
18:14 Apr 09, 2014
Jkt 232001
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\10APN1.SGM
10APN1
19915
Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Form name
Patients .............................................
Controls .............................................
Case questionnaire ..........................
Control questionnaire .......................
Average
burden
per response
(in hours)
Total
[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.
1
1
25/60
25/60
67
201
........................
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.
161
483
........................
........................
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
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: infocollection@acf.hhs.gov.
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.
sroberts on DSK5SPTVN1PROD with NOTICES
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:
VerDate Mar<15>2010
18:14 Apr 09, 2014
Jkt 232001
PO 00000
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
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\10APN1.SGM
10APN1
]]>Agencies
[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19914-19915]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08014]
-----------------------------------------------------------------------
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 omb@cdc.gov.
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Form name Number of responses per per response Total
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Patients...................... Case 161 1 25/60 67
questionnaire.
Controls...................... Control 483 1 25/60 201
questionnaire.
---------------------------------------------------------------
.............. .............. .............. 268
----------------------------------------------------------------------------------------------------------------
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
