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ESTIMATED ANNUALIZED BURDEN HOURS
Form name

EDN data entry staff at state and local health
departments.

The EDN Tuberculosis Follow-up Worksheet
for Newly-Arrived Persons With Overseas
Tuberculosis Classifications.

Jeffrey 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. 2018–10064 Filed 5–10–18; 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.

SUMMARY:

sradovich on DSK3GMQ082PROD with NOTICES

Number of
respondents

Type of respondents

CDC must receive written
comments on or before July 10, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0042 by any of the following methods:
DATES:

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• 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;

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Number of
responses per
respondent

550

48

Average
burden per
response
(in hours)
30/60

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, 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

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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

‘‘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.

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
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

sradovich on DSK3GMQ082PROD 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).

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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

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued

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Type of respondents

Number of
respondents

Form name

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.

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Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

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

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

240

20/60

480,000

50
2,600

250
1

25/60
2

5,208
5,200

2,600

12

20/60

10,400

2,600

12

20/60

10,400

2,600

14

35/60

18,200

2,600
2,600
2,600

12
12
12

5/60
4.17
5/60

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

200

20/60

3,333

50
50

50
30

1
15/60

2,500
375

50
50

50
50

15/60
10/60

625
417

500

1

1.42

708

500

12

1/60

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

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents

Number of
respondents

Form name

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.

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

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

Average
burden per
response
(in hours)

Number of
responses per
respondent

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

5,000

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

12
60
12

5/60
25/60
10/60

7,000
175,000
14,000

2,000

12

1.42

17,000

325

75

10/60

4,063

325

5

10/60

271

350

1

30/60

175

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

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

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

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. 2018–10094 Filed 5–10–18; 8:45 am]
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(in hours)

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