Proposed Data Collection Submitted for Public Comment and Recommendations, 45444-45447 [2018-19382]
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45444
Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
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: On August
22, 2018 CDC published a notice in the
Federal Register titled ‘‘Information
Collection for Tuberculosis Data from
Panel Physicians’’ (Vol. 83, No. 163
Docket No. CDC–2018–0049, Pages
42502–542503). This notice was
published inadvertently. The notice is
being withdrawn immediately for public
comment.
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. 2018–19383 Filed 9–6–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0666; Docket No. CDC–2018–
0042]
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 National Healthcare Safety
Network (NHSN). 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.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
CDC must receive written
comments on or before November 6,
2018.
DATES:
VerDate Sep<11>2014
17:55 Sep 06, 2018
Jkt 244001
You may submit comments,
identified by Docket No. CDC–2018–
0042 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 Leroy A.
Richardson, 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
ADDRESSES:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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
National Healthcare Safety Network
(NHSN)—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. The data
collected will be used to inform and
detect changes in the epidemiology of
adverse events resulting from new and
current medical therapies and changing
risks. NHSN is comprised of six
components: Patient Safety, Healthcare
Personnel Safety, Biovigilance, LongTerm Care Facility, Outpatient
Procedure, and Dialysis.
Changes were made to 33 data
collection facility surveys with this new
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
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
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
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 HealthcareAssociated 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
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 33 forms within the
package to clarify and/or update
surveillance definitions, increase or
decrease the number of reporting
facilities, and add new forms.
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.
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
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).
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.
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Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
(in hours)
2,000
2,000
6,000
1
1
1
5/60
10/60
1.17
167
333
7,500
1,000
6,000
6,000
1,800
6,000
100
1
12
44
72
144
120
5/60
15/60
33/60
30/60
28/60
30/60
83
18,000
145,200
64,800
403,200
6,000
6,000
600
6,000
40
91
12
20/60
35/60
4
80,000
31,850
288,000
2,000
9
5.03
90,600
6,000
60
5.03
1,812,000
6,000
6,000
55
36
540
1
35/60
10/60
45/60
126,000
540,000
41
1,000
12
5/60
1,000
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
daltland on DSKBBV9HB2PROD with NOTICES
Type of respondents
Number of
respondents
Form name
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.
57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction.
57.320 Hemovigilance Adverse Reaction—Other
Transfusion Reaction.
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Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
(in hours)
2,000
12
5/60
2,000
100
100
25/60
4,167
6,000
6,000
72
24
30/60
15/60
216,000
36,000
6,000
50
2,600
240
250
1
20/60
25/60
2
480,000
5,208
5,200
2,600
12
20/60
10,400
2,600
12
20/60
10,400
2,600
2,600
2,600
2,600
14
12
12
12
35/60
5/60
4.17
5/60
18,200
2,600
130,000
2,600
400
1,000
50
1
1
1
1.17
1.17
8
467
1,167
400
19,500
1
5/60
1,625
50
50
50
50
50
200
50
30
50
50
20/60
1
15/60
15/60
10/60
3,333
2,500
375
625
417
500
500
1
12
1.42
1/60
708
100
500
12
1.17
7,000
500
200
10
1
10/60
35/60
833
117
500
4
20/60
667
500
4
20/60
667
500
1
20/60
167
500
2
20/60
333
500
4
20/60
667
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
2
20/60
333
500
1
20/60
167
500
1
20/60
167
E:\FR\FM\07SEN1.SGM
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Total .................
Total
burden
(in hours)
1
10/60
417
5,000
12
20/60
15,000
1,200
25
40/60
20,000
1,200
12
40/60
9,600
5,000
540
10/60
450,000
5,000
36
35/60
105,000
7,000
1
2.12
14,817
7,000
7,000
7,000
2,000
12
60
12
12
5/60
25/60
10/60
1.42
7,000
175,000
14,000
17,000
325
325
75
5
10/60
10/60
4,063
271
350
1
30/60
175
....................................................................................
........................
........................
........................
5,393,725
BILLING CODE 4163–18–P?≤
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Community Preventive
Services Task Force (CPSTF)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
Notice of meeting.
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services announces the next meeting of
the Community Preventive Services
Task Force (CPSTF) on October 17–18,
2018, in Atlanta, Georgia.
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
Average
burden per
response
(in hours)
5,000
[FR Doc. 2018–19382 Filed 9–6–18; 8:45 am]
The meeting will be held on
Wednesday, October 17, 2018, from 8:30
a.m. to 6:00 p.m. EDT and Thursday,
October 18, 2018, from 8:30 a.m. to 1:00
p.m. EDT.
DATES:
VerDate Sep<11>2014
Number of
responses per
respondent
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.
ACTION:
Number of
respondents
Form name
17:55 Sep 06, 2018
Jkt 244001
The CPSTF Meeting will be
held at the CDC Edward R. Roybal
Campus, Centers for Disease Control
and Prevention Headquarters (Building
19), 1600 Clifton Road NE, Atlanta, GA
30329. You should be aware that the
meeting location is in a Federal
government building; therefore, Federal
security measures are applicable. For
additional information, please see
Roybal Campus Security Guidelines
under SUPPLEMENTARY INFORMATION.
Information regarding meeting logistics
will be available on the Community
Guide website (www.thecommunity
guide.org) closer to the date of the
meeting.
FOR FURTHER INFORMATION CONTACT:
Onslow Smith, Center for Surveillance,
Epidemiology and Laboratory Services;
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
E–69, Atlanta, GA 30329, phone: (404)
498–6778, email: CPSTF@cdc.gov.
SUPPLEMENTARY INFORMATION:
Meeting Accessibility: This spacelimited meeting is open to the public.
All meeting attendees must register. To
ensure completion of required security
procedures and access to the CDC’s
Global Communications Center, U.S.
citizens intending to attend in person
must register by October 10, 2018, and
non-U.S. citizens intending to attend in
person must register by September 19,
2018. Failure to register by the dates
ADDRESSES:
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Fmt 4703
Sfmt 4703
identified could result in the inability to
attend the CPSTF meeting in person.
Those unable to attend the meeting in
person are able to do so via Webcast.
CDC will send the Webcast URL to
registrants upon receipt of their
registration. All meeting attendees must
register by October 11, 2018 to receive
the webcast information. CDC will email
webcast information from the CPSTF@
cdc.gov mailbox.
To register for the meeting, whether in
person or via webcast, individuals
should send an email to CPSTF@cdc.gov
and include the following information:
name, title, organization name,
organization address, phone, email, and
whether attending in person or via
webcast.
Public Comment: A public comment
period, limited to three minutes per
person, will follow the CPSTF’s
discussion of each systematic review.
Individuals wishing to make public
comments must indicate their desire to
do so with their registration by
providing their name, organizational
affiliation, and the topic to be addressed
(if known). Public comments will
become part of the meeting summary.
Public comment is not possible via
Webcast.
Background on the CPSTF: The
CPSTF is an independent, nonfederal
panel whose members are appointed by
the CDC Director. CPSTF members
E:\FR\FM\07SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45444-45447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19382]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-0666; Docket No. CDC-2018-0042]
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 National Healthcare Safety
Network (NHSN). 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.
DATES: CDC must receive written comments on or before November 6, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0042 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 Leroy A. Richardson, 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
National Healthcare Safety Network (NHSN)--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. The data collected
will be used to inform and detect changes in the epidemiology of
adverse events resulting from new and current medical therapies and
changing risks. NHSN is comprised of six components: Patient Safety,
Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility,
Outpatient Procedure, and Dialysis.
Changes were made to 33 data collection facility surveys with this
new 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 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
[[Page 45445]]
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 33 forms
within the package to clarify and/or update surveillance definitions,
increase or decrease the number of reporting facilities, and add new
forms.
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 Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare facility......... 57.100 NHSN 2,000 1 5/60 167
Registration Form.
57.101 Facility 2,000 1 10/60 333
Contact
Information.
57.103 Patient 6,000 1 1.17 7,500
Safety Component--
Annual Hospital
Survey.
57.105 Group 1,000 1 5/60 83
Contact
Information.
57.106 Patient 6,000 12 15/60 18,000
Safety Monthly
Reporting Plan.
57.108 Primary 6,000 44 33/60 145,200
Bloodstream
Infection (BSI).
57.111 Pneumonia 1,800 72 30/60 64,800
(PNEU).
57.112 Ventilator-- 6,000 144 28/60 403,200
Associated Event.
57.113 Pediatric 100 120 30/60 6,000
Ventilator--Assoc
iated Event
(PedVAE).
57.114 Urinary 6,000 40 20/60 80,000
Tract Infection
(UTI).
57.115 Custom 600 91 35/60 31,850
Event.
57.116 6,000 12 4 288,000
Denominators for
Neonatal
Intensive Care
Unit (NICU).
57.117 2,000 9 5.03 90,600
Denominators for
Specialty Care
Area (SCA)/
Oncology (ONC).
57.118 6,000 60 5.03 1,812,000
Denominators for
Intensive Care
Unit (ICU)/Other
locations (not
NICU or SCA).
57.120 Surgical 6,000 36 35/60 126,000
Site Infection
(SSI).
57.121 Denominator 6,000 540 10/60 540,000
for Procedure.
57.122 HAI 55 1 45/60 41
Progress Report
State Health
Department Survey.
57.123 1,000 12 5/60 1,000
Antimicrobial Use
and Resistance
(AUR)--Microbiolo
gy Data
Electronic Upload
Specification
Tables.
[[Page 45446]]
57.124 2,000 12 5/60 2,000
Antimicrobial Use
and Resistance
(AUR)--Pharmacy
Data Electronic
Upload
Specification
Tables.
57.125 Central 100 100 25/60 4,167
Line Insertion
Practices
Adherence
Monitoring.
57.126 MDRO or CDI 6,000 72 30/60 216,000
Infection Form.
57.127 MDRO and 6,000 24 15/60 36,000
CDI Prevention
Process and
Outcome Measures
Monthly
Monitoring.
57.128 Laboratory- 6,000 240 20/60 480,000
identified MDRO
or CDI Event.
57.129 Adult 50 250 25/60 5,208
Sepsis.
57.137 Long-Term 2,600 1 2 5,200
Care Facility
Component--Annual
Facility Survey.
57.138 Laboratory- 2,600 12 20/60 10,400
identified MDRO
or CDI Event for
LTCF.
57.139 MDRO and 2,600 12 20/60 10,400
CDI Prevention
Process Measures
Monthly
Monitoring for
LTCF.
57.140 Urinary 2,600 14 35/60 18,200
Tract Infection
(UTI) for LTCF.
57.141 Monthly 2,600 12 5/60 2,600
Reporting Plan
for LTCF.
57.142 2,600 12 4.17 130,000
Denominators for
LTCF Locations.
57.143 Prevention 2,600 12 5/60 2,600
Process Measures
Monthly
Monitoring for
LTCF.
57.150 LTAC Annual 400 1 1.17 467
Survey.
57.151 Rehab 1,000 1 1.17 1,167
Annual Survey.
57.200 Healthcare 50 1 8 400
Personnel Safety
Component Annual
Facility Survey.
57.203 Healthcare 19,500 1 5/60 1,625
Personnel Safety
Monthly Reporting
Plan.
57.204 Healthcare 50 200 20/60 3,333
Worker
Demographic Data.
57.205 Exposure to 50 50 1 2,500
Blood/Body Fluids.
57.206 Healthcare 50 30 15/60 375
Worker
Prophylaxis/
Treatment.
57.207 Follow-Up 50 50 15/60 625
Laboratory
Testing.
57.210 Healthcare 50 50 10/60 417
Worker
Prophylaxis/
Treatment--Influe
nza.
57.300 500 1 1.42 708
Hemovigilance
Module Annual
Survey.
57.301 500 12 1/60 100
Hemovigilance
Module Monthly
Reporting Plan.
57.303 500 12 1.17 7,000
Hemovigilance
Module Monthly
Reporting
Denominators.
57.305 500 10 10/60 833
Hemovigilance
Incident.
57.306 200 1 35/60 117
Hemovigilance
Module Annual
Survey--Non-acute
care facility.
57.307 500 4 20/60 667
Hemovigilance
Adverse Reaction--
Acute Hemolytic
Transfusion
Reaction.
57.308 500 4 20/60 667
Hemovigilance
Adverse Reaction--
Allergic
Transfusion
Reaction.
57.309 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Delayed Hemolytic
Transfusion
Reaction.
57.310 500 2 20/60 333
Hemovigilance
Adverse Reaction--
Delayed Serologic
Transfusion
Reaction.
57.311 500 4 20/60 667
Hemovigilance
Adverse Reaction--
Febrile Non-
hemolytic
Transfusion
Reaction.
57.312 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Hypotensive
Transfusion
Reaction.
57.313 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Infection.
57.314 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Post Transfusion
Purpura.
57.315 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Transfusion
Associated
Dyspnea.
57.316 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Transfusion
Associated Graft
vs. Host Disease.
57.317 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Transfusion
Related Acute
Lung Injury.
57.318 500 2 20/60 333
Hemovigilance
Adverse Reaction--
Transfusion
Associated
Circulatory
Overload.
57.319 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Unknown
Transfusion
Reaction.
57.320 500 1 20/60 167
Hemovigilance
Adverse Reaction--
Other Transfusion
Reaction.
[[Page 45447]]
57.400 Outpatient 5,000 1 10/60 417
Procedure
Component--Annual
Facility Survey.
57.401 Outpatient 5,000 12 20/60 15,000
Procedure
Component--Monthl
y Reporting Plan.
57.402 Outpatient 1,200 25 40/60 20,000
Procedure
Component Same
Day Outcome
Measures.
57.403 Outpatient 1,200 12 40/60 9,600
Procedure
Component--Monthl
y Denominators
for Same Day
Outcome Measures.
57.404 Outpatient 5,000 540 10/60 450,000
Procedure
Component--SSI
Denominator.
57.405 Outpatient 5,000 36 35/60 105,000
Procedure
Component--Surgic
al Site (SSI)
Event.
57.500 Outpatient 7,000 1 2.12 14,817
Dialysis Center
Practices Survey.
57.501 Dialysis 7,000 12 5/60 7,000
Monthly Reporting
Plan.
57.502 Dialysis 7,000 60 25/60 175,000
Event.
57.503 Denominator 7,000 12 10/60 14,000
for Outpatient
Dialysis.
57.504 Prevention 2,000 12 1.42 17,000
Process Measures
Monthly
Monitoring for
Dialysis.
57.505 Dialysis 325 75 10/60 4,063
Patient Influenza
Vaccination.
57.506 Dialysis 325 5 10/60 271
Patient Influenza
Vaccination
Denominator.
57.507 Home 350 1 30/60 175
Dialysis Center
Practices Survey.
---------------------------------------------------------------
Total................... .................. .............. .............. .............. 5,393,725
----------------------------------------------------------------------------------------------------------------
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. 2018-19382 Filed 9-6-18; 8:45 am]
BILLING CODE 4163-18-P?>
