Proposed Data Collection Submitted for Public Comment and Recommendations, 32177-32178 [2019-14300]
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Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices
Jeffrey M. Zirger
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14303 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–19BCG; Docket No. CDC–2019–
0053]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Core Elements of Antimicrobial
Stewardship in Nursing Homes. The
goal of the information collection is to
assess the impact of an intervention on
the knowledge, attitudes, practices, and
perceived provider-level barriers to
appropriate antibiotic prescribing in a
sample of health care providers in
nursing homes. The data will be used to
monitor the effect of an intervention
aimed at improving the antibiotic
stewardship behaviors of prescribers in
long-term care settings.
DATES: CDC must receive written
comments on or before September 3,
2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0053 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:54 Jul 03, 2019
Jkt 247001
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Core Elements of Antimicrobial
Stewardship in Nursing Homes—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
32177
Background and Brief Description
The purpose of this survey is to
follow-up on formative research (OMB
Control Number 0920–1154), which
assessed the knowledge, attitudes,
practices and perceived provider-level
barriers to appropriate antibiotic
prescribing in a sample of health care
providers in nursing homes. This survey
was developed building upon
foundational work previously
completed. The questions were
originally pre-tested among a select
group (n=9) of prescribers recruited
from the participating corporations to
both obtain responses, as well as
performing cognitive assessment to
ensure clarity and robustness of content.
The preliminary findings suggested
that the questions presented were clear
and correctly understood and that the
topics covered were meaningful. The
inclusion of length of time in practice
was specifically relevant as preliminary
findings from the interviews, albeit
limited, suggest that a prescriber’s
approach and attitudes surrounding
antibiotic prescribing may be impacted
by professional tenure. Specifically,
respondents described that the longer a
prescriber had been in practice, the
more reluctant they were to modify their
prescribing behaviors.
General findings consistently centered
on the variability in nurse/provider
communication. Themes of poor
communication encompassed multiple
elements. Key themes included: Poor
structure of information sharing, the
role of gatekeepers to the prescriber,
insufficient or otherwise irrelevant
detail, and an absence of therapy
recommendation from the nurses.
Additionally, respondents described the
physical environment/geographic
context that contributed to possible
instances of over-prescribing: Limited
availability of timely or rapid test
laboratory results, sites with affiliated
labs that are closed on the weekends
(thus requiring a staff member to drive
a sample multiple hours to the nearest
hospital), limited antibiotic options in
the facility’s Emergency Kit (from which
staff frequently draw when starting a
prescription).
The current phase incorporates the
findings from previous exploratory work
and aims to address the quality of
communication between the nurses and
prescribers while also respecting the
rational for initial antibiotic initiation.
As the decision to initiate an antibiotic
prescription is largely influenced by
factors beyond the scope of this project,
the current study targeted the role of the
antibiotic follow-up to engage the
prescriber post-prescription to reassess
E:\FR\FM\05JYN1.SGM
05JYN1
32178
Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices
the appropriateness of the initial
prescription. Additional topics were
identified as important to the
respondents as they expressed support
to include questions that cover
individual perceptions of responsibility/
autonomy, the importance of the role of
family and other social pressures when
deciding to make antibiotic decisions,
and the process of following up with the
resident post-prescription. The group of
respondents were comprised of a semiconvenience sample, with efforts to
target key administrative and practicing
roles within the healthcare setting to
obtain a diverse and inclusive
perspective.
Information will be used to provide
descriptive analysis reports of the
prescribing climate within long-term
care settings. We will use these data as
comparison to the initial survey
deployment to characterize any change
demonstrated within the current
antimicrobial stewardship environment
with an effort to identify key elements
based on staff interactions, perceived
challenges, and any identifiable gaps in
knowledge. The specific elements
within the survey will be used to
identify common needs shared across
prescribers as areas for further training
or intervention development (e.g.,
identified barriers to education or
training resources will result in a more
robust education component to be
included in future work). While this
second survey is not intended to
establish a direct causal relationship, it
does aim to capture differences in a pre/
post analysis style review without
which, the initial survey would simply
provide a snapshot of current levels of
knowledge, attitudes, practices and
perceived provider-level barriers to
appropriate antibiotic prescribing.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Doctors ..............................................
Core Elements of Antimicrobial
Stewardship in Nursing Homes.
Core Elements of Antimicrobial
Stewardship in Nursing Homes.
Nurse Practitioners ...........................
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14300 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–19ACB]
Agency Forms Undergoing Paperwork
Reduction Act Review
jbell on DSK3GLQ082PROD with NOTICES
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘The Drug
Overdose Surveillance and
Epidemiology (DOSE)’’ to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on April 2,
2019 to obtain comments from the
public and affected agencies. CDC
received one comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
VerDate Sep<11>2014
17:54 Jul 03, 2019
Jkt 247001
Frm 00060
Fmt 4703
Average
burden per
response
(in hours)
Total burden
(in hours)
75
1
30/60
38
25
1
30/60
12
........................
........................
........................
50
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
PO 00000
Number of
responses per
respondent
Sfmt 4703
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Drug Overdose Surveillance and
Epidemiology (DOSE)—New—National
Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The rapid increase in opioid overdose
deaths since 2013, numerous severe
fentanyl and fentanyl analog outbreaks
occurring since 2015 across the United
States, and the declaration of the opioid
overdose epidemic as a national public
health emergency on October 26, 2017
have highlighted the urgent need to
rapidly establish and enhance timely
surveillance of suspected drug, opioid,
heroin, and stimulant overdoses. These
data are critical to inform timely local,
state, and regional response, especially
to acute and/or widespread multi-state
outbreaks.
This new data collection effort is an
essential component toward reducing
the opioid crisis, one of HHS
Department’s top priorities. DOSE data
is critical to our ability to rapidly
identify outbreaks and provide
situational awareness of changes in
emergency department (ED) visits
involving suspected drug, opioid,
heroin and stimulant overdoses at the
local, state, and regional level. This will
E:\FR\FM\05JYN1.SGM
05JYN1
Agencies
[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Pages 32177-32178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-19BCG; Docket No. CDC-2019-0053]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Core Elements of Antimicrobial
Stewardship in Nursing Homes. The goal of the information collection is
to assess the impact of an intervention on the knowledge, attitudes,
practices, and perceived provider-level barriers to appropriate
antibiotic prescribing in a sample of health care providers in nursing
homes. The data will be used to monitor the effect of an intervention
aimed at improving the antibiotic stewardship behaviors of prescribers
in long-term care settings.
DATES: CDC must receive written comments on or before September 3,
2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0053 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Core Elements of Antimicrobial Stewardship in Nursing Homes--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this survey is to follow-up on formative research
(OMB Control Number 0920-1154), which assessed the knowledge,
attitudes, practices and perceived provider-level barriers to
appropriate antibiotic prescribing in a sample of health care providers
in nursing homes. This survey was developed building upon foundational
work previously completed. The questions were originally pre-tested
among a select group (n=9) of prescribers recruited from the
participating corporations to both obtain responses, as well as
performing cognitive assessment to ensure clarity and robustness of
content.
The preliminary findings suggested that the questions presented
were clear and correctly understood and that the topics covered were
meaningful. The inclusion of length of time in practice was
specifically relevant as preliminary findings from the interviews,
albeit limited, suggest that a prescriber's approach and attitudes
surrounding antibiotic prescribing may be impacted by professional
tenure. Specifically, respondents described that the longer a
prescriber had been in practice, the more reluctant they were to modify
their prescribing behaviors.
General findings consistently centered on the variability in nurse/
provider communication. Themes of poor communication encompassed
multiple elements. Key themes included: Poor structure of information
sharing, the role of gatekeepers to the prescriber, insufficient or
otherwise irrelevant detail, and an absence of therapy recommendation
from the nurses. Additionally, respondents described the physical
environment/geographic context that contributed to possible instances
of over-prescribing: Limited availability of timely or rapid test
laboratory results, sites with affiliated labs that are closed on the
weekends (thus requiring a staff member to drive a sample multiple
hours to the nearest hospital), limited antibiotic options in the
facility's Emergency Kit (from which staff frequently draw when
starting a prescription).
The current phase incorporates the findings from previous
exploratory work and aims to address the quality of communication
between the nurses and prescribers while also respecting the rational
for initial antibiotic initiation. As the decision to initiate an
antibiotic prescription is largely influenced by factors beyond the
scope of this project, the current study targeted the role of the
antibiotic follow-up to engage the prescriber post-prescription to
reassess
[[Page 32178]]
the appropriateness of the initial prescription. Additional topics were
identified as important to the respondents as they expressed support to
include questions that cover individual perceptions of responsibility/
autonomy, the importance of the role of family and other social
pressures when deciding to make antibiotic decisions, and the process
of following up with the resident post-prescription. The group of
respondents were comprised of a semi-convenience sample, with efforts
to target key administrative and practicing roles within the healthcare
setting to obtain a diverse and inclusive perspective.
Information will be used to provide descriptive analysis reports of
the prescribing climate within long-term care settings. We will use
these data as comparison to the initial survey deployment to
characterize any change demonstrated within the current antimicrobial
stewardship environment with an effort to identify key elements based
on staff interactions, perceived challenges, and any identifiable gaps
in knowledge. The specific elements within the survey will be used to
identify common needs shared across prescribers as areas for further
training or intervention development (e.g., identified barriers to
education or training resources will result in a more robust education
component to be included in future work). While this second survey is
not intended to establish a direct causal relationship, it does aim to
capture differences in a pre/post analysis style review without which,
the initial survey would simply provide a snapshot of current levels of
knowledge, attitudes, practices and perceived provider-level barriers
to appropriate antibiotic prescribing.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Doctors....................... Core Elements of 75 1 30/60 38
Antimicrobial
Stewardship in
Nursing Homes.
Nurse Practitioners........... Core Elements of 25 1 30/60 12
Antimicrobial
Stewardship in
Nursing Homes.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-14300 Filed 7-3-19; 8:45 am]
BILLING CODE 4163-18-P