60 day FRN

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Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents

Form No. & name
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 ...........................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–25576 Filed 11–18–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–21AT; Docket No. CDC–2020–
0114]

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 Evaluation of Venous

SUMMARY:

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Avg. burden
per response
(min./hour)

Total burden
(hours)

500

1

20/60

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
7,200
7,200
7,200
7,200
1,730
615
615
430

400
100
5
1
12
30
30
12
50
5
1

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

53,333
46,667
2,333
15,240
7,200
90,000
14,400
25,950
5,125
513
215

Thromboembolism Prevention Practices
in U.S. Hospitals. This proposed study
is designed to support a framework for
improving hospital venous
thromboembolism (VTE) prevention
practices through the evaluation of
current VTE prevention practices in
U.S. adult general medical and surgical
hospitals.
DATES: CDC must receive written
comments on or before January 19,
2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0114 by any of the following methods:
b Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
b 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,

PO 00000

Number of
responses per
respondent

Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; Email: omb@cdc.gov.
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,

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices
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
Evaluation of Venous
Thromboembolism Prevention Practices
in U.S. Hospitals—New—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Venous thromboembolism (VTE),
which includes deep vein thrombosis
(DVT) and pulmonary embolism (PE), is
an important and growing public health
problem. Each year in the U.S., it is
estimated that VTE affects as many as
900,000 people, is responsible for up to
100,000 deaths, and is associated with
healthcare costs of approximately $10
billion. Recurrence after a VTE is
common, and complications include
post-thrombotic syndrome and chronic
thromboembolic pulmonary
hypertension. Over half of VTE events
are associated with recent
hospitalization or surgery and most
occur after discharge. An analysis of the
National Hospital Discharge Survey
from 2007 to 2009 estimated that almost
550,000 U.S. adult hospitalizations had
a discharge diagnosis of VTE each year.
Hospital-associated VTE (HA–VTE) is
often preventable but VTE prevention
strategies are not applied uniformly or
systematically across U.S. hospitals and
healthcare systems.
The Agency for Healthcare Research
and Quality (AHRQ) published a guide
for preventing HA–VTE in 2016. The
framework for improving VTE
prevention in hospitalized patients
includes a hospital VTE prevention
policy, an interdisciplinary VTE team,
standardization of VTE prevention
processes, monitoring of processes and
outcomes, and VTE prevention
education for providers and patients. A
VTE prevention protocol includes VTE
risk assessment, bleeding risk
assessment (risk of bleeding with
anticoagulant prophylaxis) and clinical
decision support for appropriate
prophylaxis (i.e., ambulation,

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anticoagulant prophylaxis, and/or
mechanical prophylaxis) based on both
VTE and bleeding risk assessments.
Despite evidence-based guidelines for
VTE prophylaxis in at-risk hospitalized
patients, there is systemic underuse of
appropriate VTE prophylaxis. As many
as 70% of HA–VTE events are
potentially preventable but less than
half of hospitalized patients receive
appropriate VTE prophylaxis. An
implementation gap exists between
evidence-based guidelines for VTE
prophylaxis in hospitalized adult
patients and implementation of those
guidelines in real-world hospital
settings. The 2008 Surgeon General’s
Call to Action to Prevent DVT and PE
included instituting formal systems
related to risk assessment and the
provision of prophylaxis to high-risk
hospitalized patients. For World
Thrombosis Day in 2016, the
International Society on Thrombosis
and Haemostasis (ISTH) issued a call to
clinical leaders, hospitals, and payers to
work together to make VTE risk
assessment for all hospitalized patients
a priority.
In England, The National Venous
Thromboembolism Prevention
Programme was launched in 2010 with
the goal of reducing preventable HA–
VTE morbidity and mortality (Roberts,
2017). VTE risk assessment was
mandated for all adult patients on
admission to an acute hospital utilizing
a previously developed national VTE
risk assessment tool/model. Hospitals
were required to report VTE risk
assessment rates, with a financial
incentive applied to achieve a target of
90%. This resulted in an impressive,
sustained increase in VTE risk
assessment rates with a corresponding
increase in anticoagulant prophylaxis.
There was evidence of significant
reductions in HA–VTE and associated
mortality following implementation of
this program.
Unlike England, the U.S. has no
national VTE prevention program with
hospital risk assessment rates tied to
financial incentives and no national
VTE risk assessment tool/model.
Various VTE risk assessment models
(RAMs) have been developed and
published to identify hospitalized
patients whose risk for VTE is high
enough to offset the risk of bleeding
with anticoagulant prophylaxis.
However, there is no standardized RAM
currently in use across U.S. hospitals
and healthcare systems. Implementation
of risk assessment varies in terms of the
patient population (e.g., medical vs.
surgical), time frames (e.g., on
admission, on transfer to another unit),
method of administration (i.e.,

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73717

electronic vs. paper), person/s
performing the risk assessment (e.g.,
physician, nurse, pharmacist), type of
RAM (e.g., quantitative vs. qualitative),
and linkage to a clinical decision
support tool for appropriate VTE
prophylaxis.
An evaluation of the extent to which
U.S. hospitals utilize VTE risk
assessment is needed to better
understand the landscape around VTE
prevention practices in real-world
hospital settings in order to guide efforts
and inform interventions to reduce the
burden of HA–VTE. CDC is funding The
Joint Commission to evaluate VTE
prevention practices in U.S. hospitals.
The Joint Commission has had a role in
patient safety through standards and
performance measurement. It is the
measure steward for two electronic
clinical quality measures (eCQMs) on
VTE prevention available for Center for
Medicare and Medicaid Services
Inpatient Quality Reporting and Joint
Commission hospital accreditation since
2016. However, these two VTE
prevention eCQMs only address the
initiation of VTE prophylaxis within a
specified timeframe; they do not assess
the patient’s level of VTE risk or the
appropriateness of prophylaxis.
For this project, The Joint
Commission, in collaboration with CDC,
developed a survey on hospital VTE
prevention practices. The survey was
piloted in nine hospitals and their
feedback was used to improve the
survey. After OMB approval, the survey
will be implemented by The Joint
Commission as a one-time data
collection in a nationally representative
sample of U.S. adult general medical
and surgical hospitals. No individuallevel data will be collected. CDC will
not receive any individual or hospital
identifiable information.
The overall purpose of this project is
to evaluate current VTE prevention
practices in a nationally representative
sample of U.S. hospitals (American
Hospital Association adult general
medical and surgical hospital service
category) in order to support a
framework for HA–VTE prevention. The
information collected in this hospital
survey will be used to improve
understanding of hospital VTE
prevention practices, which will guide
efforts and inform interventions to
reduce the burden of HA–VTE.
Specifically, the information collected
on hospital VTE prevention policy and
protocol, VTE prevention team, VTE
data collection and reporting, VTE risk
assessment, VTE prophylaxis safety
considerations (i.e., bleeding risk
assessment), ambulation protocol, VTE
prevention education for providers and

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73718

Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices

patients, and VTE prophylaxis
monitoring and support will be used to
assess the extent to which hospitals
apply these components of the
framework for HA–VTE prevention. The
responses to specific VTE prevention
practices can be used to assess VTE
prevention practices by hospital
characteristics (e.g., bed size, urban vs.
rural location, teaching vs. non-teaching
status) to better target efforts or
interventions to improve HA–VTE

prevention. Information collected on the
barriers to establishing a hospital-wide
VTE prevention policy will be helpful
in addressing these challenges.
Information will be collected on both
adult general medical and surgical units
since VTE prevention practices differ by
specialty. Information on VTE risk
assessment (e.g., who conducts the
assessment, when is it performed,
mandatory or optional, format, type of
RAM) will improve understanding of

real-world hospital VTE risk assessment
practices. Information on the capacity of
hospitals to collect data on VTE risk
assessment will be helpful in
determining the feasibility of VTE risk
assessment as a VTE prevention
performance measure. The data
collected can also serve as a baseline for
evaluation of future HA–VTE
prevention initiatives.

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

Number
responses per
respondent

Number of
respondents

Total burden
hours

Type of respondents

Form name

The Director of Patient Safety and Quality,
the Chairperson of the Patient Safety
Committee, other quality improvement
professional.
The Director of Patient Safety and Quality,
the Chairperson of the Patient Safety
Committee, other quality improvement
professional.

Recruitment material: Implementation email and
project information sheet.

384

1

15/60

96

Evaluation of Venous Thromboembolism Prevention
Practices in U.S. Hospitals
Questionnaire.

384

1

1

384

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

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

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

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

480

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–25574 Filed 11–18–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–0879]

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 Information
Collections to Advance State, Tribal,
Local, and Territorial (STLT)
Governmental Agency and System
Performance, Capacity, and Program
Delivery 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 05/21/
2020 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.

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19:40 Nov 18, 2020

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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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/

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do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. 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
Information Collections to Advance
State, Tribal, Local, and Territorial
(STLT) Governmental Agency and
System Performance, Capacity, and
Program Delivery (OMB Control No.
0920–0879, Exp. 1/31/2021)—
Extension—Center for State, Tribal,
Local and Territorial Support (CSTLTS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The mission of the Department of
Health and Human Services is to
enhance the health and well-being of all
Americans. As part of HHS, CDC
conducts critical science and provides
health information to people and
communities to save lives and protect
people from health threats. To this end,
CDC and HHS seek to accomplish their
mission by collaborating with partners
throughout the nation and the world to

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