Agency Forms Undergoing Paperwork Reduction Act Review, 46490-46493 [2018-19902]
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46490
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
research activities in the health field.
Historically, data have been used
extensively in the development and
monitoring of goals for the Year 2000,
2010, and 2020 Healthy People
Objectives.
There is no cost to respondents other
than their time to participate. The total
annualized burden is 7,080 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Total
burden
(in hours)
Form name
Hospital Director of Health Information Management (DHIM) or Director of Health Information Technology (DHIT).
Hospital Chief Executive Officer
(CEO)/Chief
Financial
Officer
(CFO).
Hospital DHIM or DHIT .....................
Initial Hospital Intake Questionnaire
150
1
1
150
Recruitment Survey Presentation ....
150
1
1
150
399
12
1
4,788
199
4
1
796
Hospital CEO/CFO ............................
Prepare and transmit UB–04 or
State File for Inpatient and Ambulatory.
Prepare and transmit EHR for Inpatient and Ambulatory.
Annual Hospital Interview ................
598
1
2
1,196
Total ...........................................
...........................................................
........................
........................
........................
7,080
Hospital DHIM or DHIT .....................
Jeffrey M. Zirger,
Acting 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. 2018–19901 Filed 9–12–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0666]
Agency Forms Undergoing Paperwork
Reduction Act Review
daltland on DSKBBV9HB2PROD 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 National
Healthcare Safety Network 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 May 11,
2018 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.
The Office of Management and Budget
is particularly interested in comments
that:
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
(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,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
National Healthcare Safety Network
(0920–0666, Expiration Date 1/31/
2021)—Revision—National Center for
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
NHSN is a public health surveillance
system that collects, analyzes, reports,
and makes available data for
monitoring, measuring, and responding
to healthcare associated infections
(HAIs), antimicrobial use and resistance,
blood transfusion safety events, and the
extent to which healthcare facilities
adhere to infection prevention practices
and antimicrobial stewardship.
Specifically, resulting data estimates the
magnitude of Healthcare Associated
Infections (HAI), monitor HAI trends,
and facilitate inter-facility and intrafacility comparisons with risk-adjusted
data used for local quality improvement
activities. The data will be used to
detect changes in the epidemiology of
adverse events resulting from new and
current medical therapies and changing
risks. The NHSN currently consists of
six components: Patient Safety,
Healthcare Personnel Safety,
Biovigilance, Long-Term Care Facility
(LTCF), Outpatient Procedure
Component, and Dialysis.
Changes were made to 34 data
collection facility surveys with this
revision ICR. CDC revised three annual
facility surveys for the Patient Safety
component for Hospitals, Long-Term
Acute Care Facilities, and Inpatient
Rehabilitation Facilities. CDC’s
revisions clarify the reporting
requirements for the data collected on
fungal testing, facility locations, and
laboratory testing locations.
Additionally, corresponding response
E:\FR\FM\13SEN1.SGM
13SEN1
46491
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
options for these questions have been
revised to include updated testing
methods used by facilities to capture
current HAI specific data specification
requirements for NHSN. New required
questions have been added to all Patient
Safety component surveys. The new
questions are designed to provide data
on surveillance processes, policies, and
standards that are used by reporting
facilities to ensure that when an event
is detected, the facility has the
appropriate mechanism to conduct
complete reporting. The Hospital
Annual Survey added new required
questions to provide data about neonatal
antimicrobial stewardship practices
because the focus of stewardship efforts
in neonatology differ from the focus in
adult and pediatric practice. Questions
were removed and replaced on all three
Patient Safety surveys to align better
with the Core Elements of Hospital
Antibiotic Stewardship Programs
specified by CDC. The Core Elements
defined by CDC are part of broad-based
efforts by CDC and its healthcare and
public health partners to combat the
threat of antibiotic-resistant bacteria.
The new Antibiotic Stewardship
Program questions will provide
additional data about operational
features of the programs that hospitals
have implemented, which in turn will
enable CDC and its healthcare and
public health partners to target their
efforts to help invigorate and extend
antibiotic stewardship.
CDC is introducing a new optional
survey form that is designed to be
completed by state and local health
departments that participate in HAI
surveillance and prevention activities.
This new form will provide data on
legal and regulatory requirements that
are pertinent to HAI reporting. CDC
plans to include data the health
department survey in its annual
National and State Healthcare-
Associated Infection Progress Report.
The report helps identify the progress in
HAI surveillance and prevention at the
state and national levels. Data about the
extent to which state health
departments have validated HAI data
that healthcare facilities in their
jurisdiction report to NHSN and the
extent of state and local health
department HAI reporting requirements
are important data for users of CDC’s
HAI Progress Report to consider when
they are reviewing and interpreting data
in the report.
NHSN now includes a ventilatorassociated event available for NICU
locations, which requires additional
denominator reporting, in which CDC
has provided an option to accommodate
facilities that are reporting requested
data by updating the corresponding
surveys. The Pediatric VentilatorAssociated Event (PedVAE) was
removed from the survey because a
single algorithm is used to detect
PedVAE events.
NHSN has made updates to the
Antimicrobial Use and Resistance
(AUR) data collection tools for the
purposes of monitoring additional
microorganisms and their antimicrobial
susceptibility profiles. Use of these
updates in AUR surveillance will
provide important additional data for
clinical and public health responses to
mounting antibiotic resistance
problems.
The Long-term Care Facility
Component (LTCF) will be updating
three forms, two of which will include
an update for facilities to document the
‘‘CDI treatment start’’ variable. Early CDI
reporting data from nursing homes has
shown exceptionally low event rates for
many reporting facilities (e.g., zero
events for six or more months). Since
current CDI event detection is based on
presence of a positive laboratory
specimen, variability in the use of
diagnostic testing as part of CDI
management will have direct impact on
the estimate of CDI burden in a facility
(e.g., empiric treatment for CDI without
confirmatory testing may result in the
appearance of low disease burden). In
order to determine whether low CDI
event rates might be due to empiric CDI
treatment practices, a new process
measure will be incorporated into the
monthly summary data on CDI for
LTCFs. This measure, called ‘‘CDI
treatment starts,’’ will allow providers
to capture the number of residents
started on antibiotic treatment for CDI
that month based on clinical decisions
(i.e., even those without a positive CDI
test). This process measure should
provide data on clinically-treated CDI in
order to inform our understanding of
CDI management practices and serve as
a proxy for CDI burden in nursing
homes.
Overall, minor revisions have been
made to a total of 34 forms within the
package to clarify and/or update
surveillance definitions, increase or
decrease the number of reporting
facilities, and add new forms.
Finally, NHSN has achieved
significant burden reduction with this
ICR due to a decrease in the number of
respondents for the Specialty Care Area
(SCA) and Oncology (ONC) facilities
reporting to NHSN. NHSN re-evaluated
these reporting facilities and determined
that approximately 2,000 SCA and ONC
facilities are reporting to NHSN
compared to the estimated 6,000 that
was estimated last year. Additionally,
NHSN streamlined many response
options, which also attributed to a
reduction in the overall burden.
The previously approved NHSN
package included 72 individual
collection forms; the current revision
request includes a total of 73 forms. The
reporting burden will decrease by
109,745 hours, for a total of 5,393,725
hours.
daltland on DSKBBV9HB2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Healthcare facility ...................
57.100 NHSN Registration Form ...........................................
57.101 Facility Contact Information .......................................
57.103 Patient Safety Component—Annual Hospital Survey
57.105 Group Contact Information .........................................
57.106 Patient Safety Monthly Reporting Plan ......................
57.108 Primary Bloodstream Infection (BSI) .........................
57.111 Pneumonia (PNEU) ....................................................
57.112 Ventilator-Associated Event .......................................
57.113 Pediatric Ventilator-Associated Event (PedVAE) .......
57.114 Urinary Tract Infection (UTI) ......................................
57.115 Custom Event .............................................................
57.116 Denominators for Neonatal Intensive Care Unit
(NICU).
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19:20 Sep 12, 2018
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E:\FR\FM\13SEN1.SGM
2,000
2,000
6,000
1,000
6,000
6,000
1,800
6,000
100
6,000
600
6,000
13SEN1
Number of
responses per
respondent
1
1
1
1
12
44
72
144
120
40
91
12
Average
burden per
response
(in hours)
5/60
10/60
75/60
5/60
15/60
33/60
30/60
28/60
30/60
20/60
35/60
4
46492
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
daltland on DSKBBV9HB2PROD with NOTICES
Type of respondents
Number of
respondents
Form name
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC).
57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA).
57.120 Surgical Site Infection (SSI) .......................................
57.121 Denominator for Procedure ........................................
57.122 HAI Progress Report State Health Department Survey.
57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables.
57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy
Data Electronic Upload Specification Tables.
57.125 Central Line Insertion Practices Adherence Monitoring.
57.126 MDRO or CDI Infection Form ....................................
57.127 MDRO and CDI Prevention Process and Outcome
Measures Monthly Monitoring.
57.128 Laboratory-identified MDRO or CDI Event ................
57.129 Adult Sepsis ...............................................................
57.137 Long-Term Care Facility Component—Annual Facility Survey.
57.138 Laboratory-identified MDRO or CDI Event for LTCF
57.139 MDRO and CDI Prevention Process Measures
Monthly Monitoring for LTCF.
57.140 Urinary Tract Infection (UTI) for LTCF .......................
57.141 Monthly Reporting Plan for LTCF ..............................
57.142 Denominators for LTCF Locations .............................
57.143 Prevention Process Measures Monthly Monitoring
for LTCF.
57.150 LTAC Annual Survey .................................................
57.151 Rehab Annual Survey ................................................
57.200 Healthcare Personnel Safety Component Annual Facility Survey.
57.203 Healthcare Personnel Safety Monthly Reporting Plan
57.204 Healthcare Worker Demographic Data ......................
57.205 Exposure to Blood/Body Fluids ..................................
57.206 Healthcare Worker Prophylaxis/Treatment ................
57.207 Follow-Up Laboratory Testing ....................................
57.210 Healthcare Worker Prophylaxis/Treatment-Influenza
57.300 Hemovigilance Module Annual Survey ......................
57.301 Hemovigilance Module Monthly Reporting Plan ........
57.303 Hemovigilance Module Monthly Reporting Denominators.
57.305 Hemovigilance Incident ..............................................
57.306 Hemovigilance Module Annual Survey—Non-acute
care facility.
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic
Transfusion Reaction.
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction.
57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction.
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction.
57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction.
57.312 Hemovigilance Adverse Reaction—Hypotensive
Transfusion Reaction.
57.313 Hemovigilance Adverse Reaction—Infection .............
57.314 Hemovigilance Adverse Reaction—Post Transfusion
Purpura.
57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea.
57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease.
57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury.
57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload.
VerDate Sep<11>2014
19:20 Sep 12, 2018
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Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
2,000
9
302/60
6,000
60
302/60
6,000
6,000
55
36
540
1
35/60
10/60
45/60
1,000
12
5/60
2,000
12
5/60
100
100
25/60
6,000
6,000
72
24
30/60
15/60
6,000
50
2,600
240
250
1
20/60
25/60
2
2,600
2,600
12
12
20/60
20/60
2,600
2,600
2,600
2,600
14
12
12
12
35/60
5/60
250/60
5/60
400
1,000
50
1
1
1
70/60
70/60
8
19,500
50
50
50
50
50
500
500
500
1
200
50
30
50
50
1
12
12
5/60
20/60
1
15/60
15/60
10/60
85/60
1/60
70/60
500
200
10
1
10/60
35/60
500
4
20/60
500
4
20/60
500
1
20/60
500
2
20/60
500
4
20/60
500
1
20/60
500
500
1
1
20/60
20/60
500
1
20/60
500
1
20/60
500
1
20/60
500
2
20/60
E:\FR\FM\13SEN1.SGM
13SEN1
46493
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Number of
respondents
Form name
57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction.
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction.
57.400 Outpatient Procedure Component—Annual Facility
Survey.
57.401 Outpatient Procedure Component—Monthly Reporting Plan.
57.402 Outpatient Procedure Component Same Day Outcome Measures.
57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures.
57.404 Outpatient Procedure Component—SSI Denominator.
57.405 Outpatient Procedure Component—Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis Center Practices Survey .............
57.501 Dialysis Monthly Reporting Plan ................................
57.502 Dialysis Event .............................................................
57.503 Denominator for Outpatient Dialysis ..........................
57.504 Prevention Process Measures Monthly Monitoring
for Dialysis.
57.505 Dialysis Patient Influenza Vaccination .......................
57.506 Dialysis Patient Influenza Vaccination Denominator
57.507 Home Dialysis Center Practices Survey ....................
Jeffrey M. Zirger,
Acting 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. 2018–19902 Filed 9–12–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0294]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Contact
Substance Notification Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Electronic Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:20 Sep 12, 2018
response to the notice. This notice
solicits comments on the information
collection associated with the Food
Contact Substance Notification Program.
DATES: Submit either electronic or
written comments on the collection of
information by November 13, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 13,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 13, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Jkt 244001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
500
1
20/60
500
1
20/60
5,000
1
10/60
5,000
12
20/60
1,200
25
40/60
1,200
12
40/60
5,000
540
10/60
5,000
36
35/60
7,000
7,000
7,000
7,000
2,000
1
12
60
12
12
127/60
5/60
25/60
10/60
85/60
325
325
350
75
5
1
10/60
10/60
30/60
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0294 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46490-46493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19902]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled National Healthcare Safety Network 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 May 11, 2018 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. 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 [email protected]. 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, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
National Healthcare Safety Network (0920-0666, Expiration Date 1/
31/2021)--Revision--National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
NHSN is a public health surveillance system that collects,
analyzes, reports, and makes available data for monitoring, measuring,
and responding to healthcare associated infections (HAIs),
antimicrobial use and resistance, blood transfusion safety events, and
the extent to which healthcare facilities adhere to infection
prevention practices and antimicrobial stewardship. Specifically,
resulting data estimates the magnitude of Healthcare Associated
Infections (HAI), monitor HAI trends, and facilitate inter-facility and
intra-facility comparisons with risk-adjusted data used for local
quality improvement activities. The data will be used to detect changes
in the epidemiology of adverse events resulting from new and current
medical therapies and changing risks. The NHSN currently consists of
six components: Patient Safety, Healthcare Personnel Safety,
Biovigilance, Long-Term Care Facility (LTCF), Outpatient Procedure
Component, and Dialysis.
Changes were made to 34 data collection facility surveys with this
revision ICR. CDC revised three annual facility surveys for the Patient
Safety component for Hospitals, Long-Term Acute Care Facilities, and
Inpatient Rehabilitation Facilities. CDC's revisions clarify the
reporting requirements for the data collected on fungal testing,
facility locations, and laboratory testing locations. Additionally,
corresponding response
[[Page 46491]]
options for these questions have been revised to include updated
testing methods used by facilities to capture current HAI specific data
specification requirements for NHSN. New required questions have been
added to all Patient Safety component surveys. The new questions are
designed to provide data on surveillance processes, policies, and
standards that are used by reporting facilities to ensure that when an
event is detected, the facility has the appropriate mechanism to
conduct complete reporting. The Hospital Annual Survey added new
required questions to provide data about neonatal antimicrobial
stewardship practices because the focus of stewardship efforts in
neonatology differ from the focus in adult and pediatric practice.
Questions were removed and replaced on all three Patient Safety surveys
to align better with the Core Elements of Hospital Antibiotic
Stewardship Programs specified by CDC. The Core Elements defined by CDC
are part of broad-based efforts by CDC and its healthcare and public
health partners to combat the threat of antibiotic-resistant bacteria.
The new Antibiotic Stewardship Program questions will provide
additional data about operational features of the programs that
hospitals have implemented, which in turn will enable CDC and its
healthcare and public health partners to target their efforts to help
invigorate and extend antibiotic stewardship.
CDC is introducing a new optional survey form that is designed to
be completed by state and local health departments that participate in
HAI surveillance and prevention activities. This new form will provide
data on legal and regulatory requirements that are pertinent to HAI
reporting. CDC plans to include data the health department survey in
its annual National and State Healthcare-Associated Infection Progress
Report. The report helps identify the progress in HAI surveillance and
prevention at the state and national levels. Data about the extent to
which state health departments have validated HAI data that healthcare
facilities in their jurisdiction report to NHSN and the extent of state
and local health department HAI reporting requirements are important
data for users of CDC's HAI Progress Report to consider when they are
reviewing and interpreting data in the report.
NHSN now includes a ventilator-associated event available for NICU
locations, which requires additional denominator reporting, in which
CDC has provided an option to accommodate facilities that are reporting
requested data by updating the corresponding surveys. The Pediatric
Ventilator-Associated Event (PedVAE) was removed from the survey
because a single algorithm is used to detect PedVAE events.
NHSN has made updates to the Antimicrobial Use and Resistance (AUR)
data collection tools for the purposes of monitoring additional
microorganisms and their antimicrobial susceptibility profiles. Use of
these updates in AUR surveillance will provide important additional
data for clinical and public health responses to mounting antibiotic
resistance problems.
The Long-term Care Facility Component (LTCF) will be updating three
forms, two of which will include an update for facilities to document
the ``CDI treatment start'' variable. Early CDI reporting data from
nursing homes has shown exceptionally low event rates for many
reporting facilities (e.g., zero events for six or more months). Since
current CDI event detection is based on presence of a positive
laboratory specimen, variability in the use of diagnostic testing as
part of CDI management will have direct impact on the estimate of CDI
burden in a facility (e.g., empiric treatment for CDI without
confirmatory testing may result in the appearance of low disease
burden). In order to determine whether low CDI event rates might be due
to empiric CDI treatment practices, a new process measure will be
incorporated into the monthly summary data on CDI for LTCFs. This
measure, called ``CDI treatment starts,'' will allow providers to
capture the number of residents started on antibiotic treatment for CDI
that month based on clinical decisions (i.e., even those without a
positive CDI test). This process measure should provide data on
clinically-treated CDI in order to inform our understanding of CDI
management practices and serve as a proxy for CDI burden in nursing
homes.
Overall, minor revisions have been made to a total of 34 forms
within the package to clarify and/or update surveillance definitions,
increase or decrease the number of reporting facilities, and add new
forms.
Finally, NHSN has achieved significant burden reduction with this
ICR due to a decrease in the number of respondents for the Specialty
Care Area (SCA) and Oncology (ONC) facilities reporting to NHSN. NHSN
re-evaluated these reporting facilities and determined that
approximately 2,000 SCA and ONC facilities are reporting to NHSN
compared to the estimated 6,000 that was estimated last year.
Additionally, NHSN streamlined many response options, which also
attributed to a reduction in the overall burden.
The previously approved NHSN package included 72 individual
collection forms; the current revision request includes a total of 73
forms. The reporting burden will decrease by 109,745 hours, for a total
of 5,393,725 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare facility................ 57.100 NHSN Registration 2,000 1 5/60
Form.
57.101 Facility Contact 2,000 1 10/60
Information.
57.103 Patient Safety 6,000 1 75/60
Component--Annual Hospital
Survey.
57.105 Group Contact 1,000 1 5/60
Information.
57.106 Patient Safety 6,000 12 15/60
Monthly Reporting Plan.
57.108 Primary Bloodstream 6,000 44 33/60
Infection (BSI).
57.111 Pneumonia (PNEU).... 1,800 72 30/60
57.112 Ventilator- 6,000 144 28/60
Associated Event.
57.113 Pediatric Ventilator- 100 120 30/60
Associated Event (PedVAE).
57.114 Urinary Tract 6,000 40 20/60
Infection (UTI).
57.115 Custom Event........ 600 91 35/60
57.116 Denominators for 6,000 12 4
Neonatal Intensive Care
Unit (NICU).
[[Page 46492]]
57.117 Denominators for 2,000 9 302/60
Specialty Care Area (SCA)/
Oncology (ONC).
57.118 Denominators for 6,000 60 302/60
Intensive Care Unit (ICU)/
Other locations (not NICU
or SCA).
57.120 Surgical Site 6,000 36 35/60
Infection (SSI).
57.121 Denominator for 6,000 540 10/60
Procedure.
57.122 HAI Progress Report 55 1 45/60
State Health Department
Survey.
57.123 Antimicrobial Use 1,000 12 5/60
and Resistance (AUR)-
Microbiology Data
Electronic Upload
Specification Tables.
57.124 Antimicrobial Use 2,000 12 5/60
and Resistance (AUR)-
Pharmacy Data Electronic
Upload Specification
Tables.
57.125 Central Line 100 100 25/60
Insertion Practices
Adherence Monitoring.
57.126 MDRO or CDI 6,000 72 30/60
Infection Form.
57.127 MDRO and CDI 6,000 24 15/60
Prevention Process and
Outcome Measures Monthly
Monitoring.
57.128 Laboratory- 6,000 240 20/60
identified MDRO or CDI
Event.
57.129 Adult Sepsis........ 50 250 25/60
57.137 Long-Term Care 2,600 1 2
Facility Component--Annual
Facility Survey.
57.138 Laboratory- 2,600 12 20/60
identified MDRO or CDI
Event for LTCF.
57.139 MDRO and CDI 2,600 12 20/60
Prevention Process
Measures Monthly
Monitoring for LTCF.
57.140 Urinary Tract 2,600 14 35/60
Infection (UTI) for LTCF.
57.141 Monthly Reporting 2,600 12 5/60
Plan for LTCF.
57.142 Denominators for 2,600 12 250/60
LTCF Locations.
57.143 Prevention Process 2,600 12 5/60
Measures Monthly
Monitoring for LTCF.
57.150 LTAC Annual Survey.. 400 1 70/60
57.151 Rehab Annual Survey. 1,000 1 70/60
57.200 Healthcare Personnel 50 1 8
Safety Component Annual
Facility Survey.
57.203 Healthcare Personnel 19,500 1 5/60
Safety Monthly Reporting
Plan.
57.204 Healthcare Worker 50 200 20/60
Demographic Data.
57.205 Exposure to Blood/ 50 50 1
Body Fluids.
57.206 Healthcare Worker 50 30 15/60
Prophylaxis/Treatment.
57.207 Follow-Up Laboratory 50 50 15/60
Testing.
57.210 Healthcare Worker 50 50 10/60
Prophylaxis/Treatment-
Influenza.
57.300 Hemovigilance Module 500 1 85/60
Annual Survey.
57.301 Hemovigilance Module 500 12 1/60
Monthly Reporting Plan.
57.303 Hemovigilance Module 500 12 70/60
Monthly Reporting
Denominators.
57.305 Hemovigilance 500 10 10/60
Incident.
57.306 Hemovigilance Module 200 1 35/60
Annual Survey--Non-acute
care facility.
57.307 Hemovigilance 500 4 20/60
Adverse Reaction--Acute
Hemolytic Transfusion
Reaction.
57.308 Hemovigilance 500 4 20/60
Adverse Reaction--Allergic
Transfusion Reaction.
57.309 Hemovigilance 500 1 20/60
Adverse Reaction--Delayed
Hemolytic Transfusion
Reaction.
57.310 Hemovigilance 500 2 20/60
Adverse Reaction--Delayed
Serologic Transfusion
Reaction.
57.311 Hemovigilance 500 4 20/60
Adverse Reaction--Febrile
Non-hemolytic Transfusion
Reaction.
57.312 Hemovigilance 500 1 20/60
Adverse Reaction--
Hypotensive Transfusion
Reaction.
57.313 Hemovigilance 500 1 20/60
Adverse Reaction--
Infection.
57.314 Hemovigilance 500 1 20/60
Adverse Reaction--Post
Transfusion Purpura.
57.315 Hemovigilance 500 1 20/60
Adverse Reaction--
Transfusion Associated
Dyspnea.
57.316 Hemovigilance 500 1 20/60
Adverse Reaction--
Transfusion Associated
Graft vs. Host Disease.
57.317 Hemovigilance 500 1 20/60
Adverse Reaction--
Transfusion Related Acute
Lung Injury.
57.318 Hemovigilance 500 2 20/60
Adverse Reaction--
Transfusion Associated
Circulatory Overload.
[[Page 46493]]
57.319 Hemovigilance 500 1 20/60
Adverse Reaction--Unknown
Transfusion Reaction.
57.320 Hemovigilance 500 1 20/60
Adverse Reaction--Other
Transfusion Reaction.
57.400 Outpatient Procedure 5,000 1 10/60
Component--Annual Facility
Survey.
57.401 Outpatient Procedure 5,000 12 20/60
Component--Monthly
Reporting Plan.
57.402 Outpatient Procedure 1,200 25 40/60
Component Same Day Outcome
Measures.
57.403 Outpatient Procedure 1,200 12 40/60
Component--Monthly
Denominators for Same Day
Outcome Measures.
57.404 Outpatient Procedure 5,000 540 10/60
Component--SSI Denominator.
57.405 Outpatient Procedure 5,000 36 35/60
Component--Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis 7,000 1 127/60
Center Practices Survey.
57.501 Dialysis Monthly 7,000 12 5/60
Reporting Plan.
57.502 Dialysis Event...... 7,000 60 25/60
57.503 Denominator for 7,000 12 10/60
Outpatient Dialysis.
57.504 Prevention Process 2,000 12 85/60
Measures Monthly
Monitoring for Dialysis.
57.505 Dialysis Patient 325 75 10/60
Influenza Vaccination.
57.506 Dialysis Patient 325 5 10/60
Influenza Vaccination
Denominator.
57.507 Home Dialysis Center 350 1 30/60
Practices Survey.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting 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. 2018-19902 Filed 9-12-18; 8:45 am]
BILLING CODE 4163-18-P
