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in one year; this variance is due to
differences in the type of information
collected for a given survey. Specific
burden estimates for each study and
each information collection instrument
will be provided with each individual
project submission for OMB review.

Insights gained from KAP surveys will
aid in prioritizing which prevention
methods should be evaluated in future
randomized, controlled trials and
ultimately help target promotion of
proven prevention methods that could

yield substantial reductions in TBD
incidence.
The maximum estimated, annualized
burden hours are 98,830 hours. There is
no cost to respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours) *

Total burden
hours

Form name

General public, individuals or households.

20,000

1

15/60

5,000

Pest Control Operators .....................

Screening instrument (Attachment
1).
Consent form (Attachment 2) ...........
Introductory Surveys (Attachment 3)
Monthly surveys (Attachment 4) ......
Final surveys (Attachment 5) ...........
Daily surveys (Attachment 6) ...........
PCO Survey (Attachment 7) ............

10,000
10,000
10,000
10,000
10,000
1,000

1
1
12
1
60
1

20/60
30/60
15/60
30/60
5/60
30/60

3,330
5,000
30,000
5,000
50,000
500

Total ...........................................

...........................................................

........................

........................

........................

98,830

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–11647 Filed 6–4–19; 8:45 am]
BILLING CODE 4163–18–P

Centers for Disease Control and
Prevention
[60Day–19–0666; Docket No. CDC–2019–
0040]

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

SUMMARY:

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resistance, blood transfusion safety
events, and the extent to which
healthcare facilities adhere to infection
prevention practices and antimicrobial
stewardship.
Written comments must be
received on or before August 5, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019- by
any of the following methods:
• Federal eRulemaking Portal:
Regulation.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 Jeffery 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
DATES:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Number of
responses per
respondent *

Number of
respondents *

Type of respondent

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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

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Emerging and Zoonotic Infection
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality
Promotion (DHQP), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC) collects
data from healthcare facilities in the
National Healthcare Safety Network
(NHSN) under OMB Control Number
0920–0666. During the early stages of its
development, NHSN began as a
voluntary surveillance system in 2005
managed by DHQP. NHSN provides
facilities, states, regions, and the nation
with data necessary to identify problem
areas, measure the progress of
prevention efforts, and ultimately
eliminate healthcare-associated
infections (HAIs) nationwide. NHSN
allows healthcare facilities to track
blood safety errors and various
healthcare-associated infection
prevention practice methods such as
healthcare personnel influenza vaccine
status and corresponding infection
control adherence rates.
NHSN currently has six components:
Patient Safety (PS), Healthcare
Personnel Safety (HPS), Biovigilance
(BV), Long-Term Care Facility (LTCF),
Outpatient Procedure (OPC), and the
Dialysis Component. NHSN’s new
Neonatal Component is expected to
launch during the summer of 2020. This
component will focus on premature
neonates and the healthcare-associated
events that occur as a result of their
prematurity. This component will be
released with one module, which
includes Late Onset-Sepsis and
Meningitis. Late-onset sepsis (LOS) and
Meningitis are common complications
of extreme prematurity. Studies have
indicated that 36% of extremely low
gestational age (22–28 weeks) infants
develop LOS and that 21% of very low
birth weight infants surviving beyond 3
days of life will develop LOS.1
Meningitis occurs in 23% of bacteremic
infants, but 38% of infants with a
pathogen isolated from the
cerebrospinal fluid may not have an
organism isolated from blood. These
infections are usually serious, causing a
prolongation of hospital stay, increased
cost, and risk of morbidity and
mortality.
Some cases of LOS can be prevented
through proper central line insertion
and maintenance practices. These are
addressed in the CDC’s Healthcare
Infection Control Practices Advisory
Committee (CDC/HICPAC) Guidelines
for the Prevention of Intravascular
Catheter-Related Infections, 2011.

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However, almost one-third of LOS
events in a quality-improvement study
were not related to central-lines.
Prevention strategies for the non-central
line-related infection events have yet to
be fully defined, but include adherence
to hand-hygiene, parent and visitor
education, and optimum nursery design
features. Other areas that likely
influence the development of LOS
include early enteral nutritional support
and skin care practices. The data for this
module will be electronically submitted,
and manual data entry will not be
available. This will allow more hospital
personnel to be available to care for
patients and will reduce annual burden
across healthcare facilities.
Additionally, LOS data will be utilized
for prevention initiatives.
Data reported under the Patient Safety
Component are used to determine the
magnitude of the healthcare-associated
adverse events and trends in the rates of
the events, in the distribution of
pathogens, and in the adherence to
prevention practices. Data will help
detect changes in the epidemiology of
adverse events resulting from new
medical therapies and changing patient
risks. Additionally, reported data is
being used to describe the epidemiology
of antimicrobial use and resistance and
to better understand the relationship of
antimicrobial therapy to this rising
problem. Under the Healthcare
Personnel Safety Component, protocols
and data on events—both positive and
adverse—are used to determine (1) the
magnitude of adverse events in
healthcare personnel, and (2)
compliance with immunization and
sharps injuries safety guidelines. Under
the Biovigilance Component, data on
adverse reactions and incidents
associated with blood transfusions are
reported and analyzed to provide
national estimates of adverse reactions
and incidents. Under the Long-Term
Care Facility Component, data is
captured from skilled nursing facilities.
Reporting methods under the LTCF
component have been created by using
forms from the PS Component as a
model with modifications to specifically
address the specific characteristics of
LTCF residents and the unique data
needs of these facilities reporting into
NHSN. The Dialysis Component offers a
simplified user interface for dialysis
users to streamline their data entry and
analyses processes as well as provide
options for expanding in the future to
include dialysis surveillance in settings
other than outpatient facilities. The
Outpatient Procedure Component (OPC)
gathers data on the impact of infections
and outcomes related to operative

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26111

procedures performed in Ambulatory
Surgery Centers (ASCs). The OPC is
used to monitor two event types: Same
Day Outcome Measures and Surgical
Site Infections (SSIs).
NHSN has increasingly served as the
operating system for HAI reporting
compliance through legislation
established by the states. As of March
2019, 36 states, the District of Columbia
and the City of Philadelphia,
Pennsylvania have opted to use NHSN
as their primary system for mandated
reporting. Reporting compliance is
completed by healthcare facilities in
their respective jurisdictions, with
emphasis on those states and
municipalities acquiring varying
consequences for failure to use NHSN.
Additionally, healthcare facilities in five
U.S. territories (Puerto Rico, American
Samoa, the U.S. Virgin Islands, Guam,
and the Northern Mariana Islands) are
voluntarily reporting to NHSN.
Additional territories are projected to
follow with similar use of NHSN for
reporting purposes.
NHSN’s data is used to aid in the
tracking of HAIs and guide infection
prevention activities/practices that
protect patients. The Centers for
Medicare and Medicaid Services (CMS)
and other payers use these data to
determine incentives for performance at
healthcare facilities across the U.S. and
surrounding territories, and members of
the public may use some protected data
to inform their selection among
available providers. Each of these
parties is dependent on the
completeness and accuracy of the data.
CDC and CMS work closely and are
fully committed to ensuring complete
and accurate reporting, which are
critical for protecting patients and
guiding national, state, and local
prevention priorities.
CMS collects some HAI data and
healthcare personnel influenza
vaccination summary data, which is
done on a voluntary basis as part of its
Fee-for-Service Medicare quality
reporting programs, while others may
report data required by a federal
mandate. Facilities that fail to report
quality measure data are subject to
partial payment reduction in the
applicable Medicare Fee-for-Service
payment system. CMS links their
quality reporting to payment for
Medicare-eligible acute care hospitals,
inpatient rehabilitation facilities, longterm acute care facilities, oncology
hospitals, inpatient psychiatric
facilities, dialysis facilities, and
ambulatory surgery centers. Facilities
report HAI data and healthcare
personnel influenza vaccination
summary data to CMS via NHSN as part

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Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices

of CMS’s quality reporting programs to
receive full payment. Still, many
healthcare facilities, even in states
without HAI reporting legislation,
submit limited HAI data to NHSN
voluntarily.
NHSN’s data collection updates
continue to support the incentive
programs managed by CMS. For
example, survey questions support
requirements for CMS’ quality reporting
programs. Additionally, CDC has
collaborated with CMS on a voluntary
National Nursing Home Quality

for a total of 73 proposed data collection
forms. The proposed revisions to the
information collection tools in NHSN
include 38 changes to previously
approved data collection tools.
Incorporating all proposed revisions, the
estimated burden for reporting reflects a
decrease in hours by 2,472,007 hours for
a total annual burden of 3,031,463
hours. Subsequently, the estimated cost
burden reflects a decrease of
$86,726,153 for a total annual cost of
$110,756,566.

Collaborative, which focuses on
recruiting nursing homes to report HAI
data to NHSN and to retain their
continued participation. This project
has resulted in a significant increase in
long-term care facilities reporting to
NHSN. The collection of information is
authorized by the Public Health Service
Act (42 U.S.C. 242b, 242k, and 242m
(d)), (Attachment A).
The ICR previously approved in
November of 2018 included revisions to
34 data collection forms and the
addition of one new Patient Safety form

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

jbell on DSK3GLQ082PROD with NOTICES

Form No. and name

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 ..............................................................
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 ..

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Number of
responses per
respondent

Average
burden per
response
(min./hour)

Total burden
(hours)

2,000
2,000
5,175
1,000
6,000
5,775
1,800
5,500
334
5,500
600
220
165

1
1
1
1
12
5
30
5
120
5
91
12
12

5/60
10/60
75/60
5/60
15/60
38/60
30/60
28/60
30/60
20/60
35/60
249/60
302/60

167
333
6,469
83
18,000
18,288
27,000
12,833
20,040
9,167
31,850
10,956
9,966

5,500
4,500
4,500
55

60
11
680
1

302/60
35/60
10/60
45/60

1,661,000
28,875
510,000
41

1,500

12

5/60

1,500

2,000
500
720

12
213
12

5/60
25/60
30/60

2,000
44,375
4,320

5,500
4,800
50
2,220
2,150

29
87
250
1
24

15/60
20/60
25/60
120/60
15/60

39,875
139,200
5,208
4,440
12,900

2,200
400
2,220
2,220
375
500
1,200
50
........................
50
50
50
50
50
500
500
500
500
500

12
12
12
12
12
1
1
1
1
200
50
30
50
50
1
12
12
10
1

20/60
30/60
5/60
250/60
5/60
70/60
70/60
480/60
5/60
20/60
60/60
15/60
15/60
10/60
85/60
1/60
70/60
10/60
35/60

8,800
2,400
2,220
111,000
375
583
1,400
400
........................
3,333
2,500
375
625
417
708
100
7,000
833
292

500
500

4
4

20/60
20/60

667
667

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Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents

Form No. and name

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 .....
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 ...........................................
Total Estimated Annual Burden (Hours) ..................................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–11650 Filed 6–4–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–19AUK; Docket No. CDC–2019–
0041]

jbell on DSK3GLQ082PROD with NOTICES

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

SUMMARY:

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Jkt 247001

20/60

167

500

2

20/60

333

500

4

20/60

667

500
500
500

1
1
1

20/60
20/60
20/60

167
167
167

500

1

20/60

167

500

1

20/60

167

500

1

20/60

167

500
500
500
700
700
200

2
1
1
1
12
1

20/60
20/60
20/60
10/60
15/60
40/60

333
167
167
117
2,100
133

200
700
700
7,100
7,100
7,100
7,100
1,760
860
860
430

400
100
5
1
12
30
12
12
60
1
1

40/60
40/60
40/60
127/60
5/60
25/60
10/60
75/60
10/60
5/60
30/60

53,333
46,667
2,333
15,028
7,100
88,750
14,200
26,400
8,600
72
215

........................

........................

........................

3,031,463

CDC must receive written
comments on or before August 5, 2019.

Fmt 4703

Total burden
(hours)

1

DATES:

Frm 00050

Average
burden per
response
(min./hour)

500

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 Promoting Adolescent Health
through School-Based HIV Prevention.
CDC will use a web-based system to
collect data on the strategies that funded
Local Education Agencies (LEAs) are
using to meet their goals related to three
strategies: Deliver sexual health
education emphasizing HIV and other
STD prevention (SHE); Increase
adolescent access to key sexual health
services (SHS); and Establish safe and
supportive environments for students
and staff (SSE).

PO 00000

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responses per
respondent

Sfmt 4703

You may submit comments,
identified by Docket No. CDC–2019–
0041 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,
ADDRESSES:

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