Proposed Data Collections Submitted for Public Comment and Recommendations, 8460-8461 [2014-03013]
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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
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[FR Doc. 2014–02940 Filed 2–11–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSK4VPTVN1PROD with NOTICES
[30Day–14–13AHB]
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
VerDate Mar<15>2010
17:11 Feb 11, 2014
Jkt 232001
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
Risk Factors for CommunityAssociated Clostridium difficile
Infection through the Emerging
Infections Program (EIP)—New ICR—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The epidemiology of C. difficile has
changed dramatically during recent
years, with increases in incidence and
severity of disease being reported across
several countries. In addition,
populations previously thought to be at
low risk, such as young, healthy
individuals residing in the community,
are now being identified with severe C.
difficile infection (CDI). Communityassociated CDI is estimated to represent
32% of all CDI based on populationbased CDI surveillance data, with an
incidence of 30–40 per 100,000
population in the United States.
Previous reports have shown that
approximately 40% of patients
acquiring community-associated CDI
(CA–CDI) were not exposed to
antibiotics, which is a well-recognized
risk factor for CDI; suggesting that
additional factors may contribute to
infections. Other factors such as proton
pump inhibitors have been raised as a
risk factor for CDI in the community and
on February 8, 2012 the U.S. Food and
Drug Administration issued a
communication advising physicians to
consider the diagnosis of CDI among
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
patients taking proton pump inhibitors.
However, the data on the association of
CDI with proton pump inhibitors are
still controversial and studies to
quantify this association are needed. In
addition to the understanding of the
factors that predispose patients to CDI,
further evaluation of potential C.
difficile exposure sources in the
community is necessary to guide
prevention efforts.
The sources of C. difficile and the
risks for developing CDI in previously
thought to be low-risk community
populations are not well defined.
Although initial evaluation of CA–CDI
cases identified several potential risk
factors (e.g., outpatient healthcare
exposures, infants in the home, and
proton pump inhibitor use), the
magnitude of association of these risks
with disease development using a
control population has not been
evaluated to date. This proposed casecontrol study will enable investigators
to evaluate these associations and focus
future investigations and prevention
strategies on those factors identified as
significantly associated with disease
development.
CDC requests OMB approval to collect
information from the public using a
standardized questionnaire over a threeyear period. The study will have a
pediatric and an adult component given
that C. difficile exposure sources in the
community may vary by age. For
example, C. difficile has been isolated
from daycare centers’ environment
which may be a potential source for C.
difficile acquisition in pediatric
population, but less likely to be a source
for adults.
For this project, we estimate that 129
persons ≥ 18 years of age with C.
difficile infection (case-patients) will be
contacted for the CDI study interview
annually. Of those, 71 will agree and be
eligible to participate in the study and
will proceed to the full telephone
interview. A total of 142 persons ≥ 18
years of age without C. difficile infection
(control-patients) will be contacted for
the interview annually. Of those, 71 will
agree and be eligible to participate in
the study and will complete the full
interview. Among the pediatric group,
we estimate that 141 and 194 parents of
children between 1 and 5 years of age
with and without C. difficile infection
will be contacted for the interview,
respectively. Among the case- and
control-patients, we estimate that 78 in
each group will agree and be eligible to
participate in the study and will
proceed to the full interview. We
anticipate the screening questions to
take about 5 minutes and the telephone
interview 30 minutes per respondent in
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12FEN1
8461
Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
both the adult and pediatric groups.
There are no costs to respondents. The
total response burden for the study 201
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Type of respondents (adult and pediatric)
Form name
Case Subjects > 17 years of age ...................
Screening Process .........................................
Telephone interview .......................................
Screening Process .........................................
Telephone interview .......................................
Screening Process .........................................
Telephone interview .......................................
Screening Process .........................................
Telephone interview .......................................
129
71
142
71
141
78
194
78
1
1
1
1
1
1
1
1
5/60
30/60
5/60
30/60
5/60
30/60
5/60
30/60
.........................................................................
........................
........................
........................
Control Subjects > 17 years of age ................
Case Subject ≤ 1–5 years of age ...................
Control Subjects ≤ 1–5 years of age ..............
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.
[FR Doc. 2014–03013 Filed 2–11–14; 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: Head Start Family and Child
Experiences Survey (FACES)
OMB No.: 0970–0151
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing to collect data for a new
round of the Head Start Family and
Child Experiences Survey (FACES).
Featuring a new ‘‘Core Plus’’ study
design, FACES will provide data on a
set of key indicators, including
information for performance measures.
The design allows for more rapid and
frequent data reporting (Core studies)
and serves as a vehicle for studying
more complex issues and topics in
greater detail and with increased
efficiency (Plus studies).
In fall 2014 and spring 2015, the
FACES Core study will assess the school
readiness skills of Head Start children,
survey their parents, and ask their Head
Start teachers to rate children’s social
and emotional skills. In spring 2015 and
again in spring 2017, the number of
programs in the FACES Core study
sample will increase from the 60 that
are used to collect data on children’s
school readiness outcomes to 180 for the
purpose of conducting observations in
720 Head Start classrooms. Program
director, center director, and teacher
surveys will also be conducted at these
time points. FACES Plus studies include
additional survey content of policy or
programmatic interest, and may involve
more programs being sampled. This
notice is specific to the data collection
activities needed to recruit Head Start
programs and centers into FACES. A
future notice will provide information
about data collection for the Core and
Plus studies.
The method of data collection for
recruitment of all programs (180 for the
FACES Core and up to 50 additional
programs for FACES Plus studies) will
include telephone conversations with
program directors and on-site
coordinators who serve as liaisons
between the FACES study team and the
Head Start centers. These calls will
inform program staff about the purpose
of the study and will be used to identify
the number of centers in each program
in order to compile the center sampling
frame.
The purpose of this data collection is
to support the 2007 reauthorization of
the Head Start program (Pub.L. 110–
134), which calls for periodic
assessments of Head Start’s quality and
effectiveness.
Respondents: Head Start Program
Directors and Staff.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hour
per response
Estimated
annual
burden hours
230
230
77
77
2
2
1
.75
154
116
Total ............................................................................
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Telephone script for program directors .............................
Telephone script for on-site coordinators ..........................
........................
........................
........................
..........................
270
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: OPRE Reports
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17:11 Feb 11, 2014
Jkt 232001
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
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Fmt 4703
Sfmt 4703
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
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]]>Agencies
[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Pages 8460-8461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03013]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-13AHB]
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
Risk Factors for Community-Associated Clostridium difficile
Infection through the Emerging Infections Program (EIP)--New ICR--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The epidemiology of C. difficile has changed dramatically during
recent years, with increases in incidence and severity of disease being
reported across several countries. In addition, populations previously
thought to be at low risk, such as young, healthy individuals residing
in the community, are now being identified with severe C. difficile
infection (CDI). Community-associated CDI is estimated to represent 32%
of all CDI based on population-based CDI surveillance data, with an
incidence of 30-40 per 100,000 population in the United States.
Previous reports have shown that approximately 40% of patients
acquiring community-associated CDI (CA-CDI) were not exposed to
antibiotics, which is a well-recognized risk factor for CDI; suggesting
that additional factors may contribute to infections. Other factors
such as proton pump inhibitors have been raised as a risk factor for
CDI in the community and on February 8, 2012 the U.S. Food and Drug
Administration issued a communication advising physicians to consider
the diagnosis of CDI among patients taking proton pump inhibitors.
However, the data on the association of CDI with proton pump inhibitors
are still controversial and studies to quantify this association are
needed. In addition to the understanding of the factors that predispose
patients to CDI, further evaluation of potential C. difficile exposure
sources in the community is necessary to guide prevention efforts.
The sources of C. difficile and the risks for developing CDI in
previously thought to be low-risk community populations are not well
defined. Although initial evaluation of CA-CDI cases identified several
potential risk factors (e.g., outpatient healthcare exposures, infants
in the home, and proton pump inhibitor use), the magnitude of
association of these risks with disease development using a control
population has not been evaluated to date. This proposed case-control
study will enable investigators to evaluate these associations and
focus future investigations and prevention strategies on those factors
identified as significantly associated with disease development.
CDC requests OMB approval to collect information from the public
using a standardized questionnaire over a three-year period. The study
will have a pediatric and an adult component given that C. difficile
exposure sources in the community may vary by age. For example, C.
difficile has been isolated from daycare centers' environment which may
be a potential source for C. difficile acquisition in pediatric
population, but less likely to be a source for adults.
For this project, we estimate that 129 persons >= 18 years of age
with C. difficile infection (case-patients) will be contacted for the
CDI study interview annually. Of those, 71 will agree and be eligible
to participate in the study and will proceed to the full telephone
interview. A total of 142 persons >= 18 years of age without C.
difficile infection (control-patients) will be contacted for the
interview annually. Of those, 71 will agree and be eligible to
participate in the study and will complete the full interview. Among
the pediatric group, we estimate that 141 and 194 parents of children
between 1 and 5 years of age with and without C. difficile infection
will be contacted for the interview, respectively. Among the case- and
control-patients, we estimate that 78 in each group will agree and be
eligible to participate in the study and will proceed to the full
interview. We anticipate the screening questions to take about 5
minutes and the telephone interview 30 minutes per respondent in
[[Page 8461]]
both the adult and pediatric groups. There are no costs to respondents.
The total response burden for the study 201 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of respondents (adult and Number of Number of burden per
pediatric) Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Case Subjects > 17 years of age....... Screening Process....... 129 1 5/60
Telephone interview..... 71 1 30/60
Control Subjects > 17 years of age.... Screening Process....... 142 1 5/60
Telephone interview..... 71 1 30/60
Case Subject <= 1-5 years of age...... Screening Process....... 141 1 5/60
Telephone interview..... 78 1 30/60
Control Subjects <= 1-5 years of age.. Screening Process....... 194 1 5/60
Telephone interview..... 78 1 30/60
-----------------------------------------------
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.
[FR Doc. 2014-03013 Filed 2-11-14; 8:45 am]
BILLING CODE 4163-18-P
