Agency Forms Undergoing Paperwork Reduction Act Review, 73713-73716 [2020-25576]
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Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices
public disclosure. Do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
CDC does not accept comment by email.
Oral Public Comment: This meeting
will include time for members of the
public to make an oral comment. Oral
public comment will occur before any
scheduled votes including all votes
relevant to the ACIP’s Affordable Care
Act and Vaccines for Children Program
roles. Priority will be given to
individuals who submit a request to
make an oral public comment before the
meeting according to the procedures
below.
Procedure for Oral Public Comment:
All persons interested in making an oral
public comment at the November ACIP
meeting must submit a request at https://
www.cdc.gov/vaccines/acip/meetings/
no later than 11:59 p.m., EST, November
19, 2020 according to the instructions
provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
time, CDC will conduct a lottery to
determine the speakers for the
scheduled public comment session.
CDC staff will notify individuals
regarding their request to speak by email
by November 20, 2020. To accommodate
the significant interest in participation
in the oral public comment session of
ACIP meetings, each speaker will be
limited to 3 minutes, and each speaker
may only speak once per meeting.
Written Public Comment: Written
comments must be received on or before
November 23, 2020.
In accordance with 41 CFR 102–
3.150(b), less than 15 calendar days’
notice is being given for this meeting
due to the exceptional circumstances of
the COVID–19 pandemic and rapidly
evolving COVID–19 vaccine
development and regulatory processes.
A notice of this ACIP meeting has also
been posted on the ACIP website at:
https://www.cdc.gov/vaccines/acip/
index.html.
In the interest of promoting openness
and transparency, we are publishing a
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late notice in the Federal Register to
inform the public.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–25658 Filed 11–17–20; 4:15 pm]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–0666]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled National
Healthcare Safety Network (NHSN) 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 June 15, 2020 to obtain
comments from the public and affected
agencies. CDC received two comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
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(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/
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
National Healthcare Safety Network
(NHSN) (OMB Control No. 0920–0666,
Exp. 12/31/2022)—Revision—National
Center for 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. 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 planned
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Neonatal Component is expected to
launch during the winter of 2020/2021.
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. These infections
are usually serious, causing a
prolongation of hospital stay, increased
cost, and risk of morbidity and
mortality. 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. A new form has been introduced
for field testing—Respiratory Tract
Infection (RTI)—not to be used by
NHSN users, but as part of an EIP
project with 4 EIP sites. Form title will
be Denominators for Healthcare
Associated Infections (HAIs):
Respiratory Tract Infections. The
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purpose of this form is to allow testing
prior to introducing a new module and
forms to NHSN users. The CDC’s
Epidemiology Research & Innovations
Branch (ERIB) team will use the form to
perform field testing of variables to
explore the utilization, applicability,
and data collection burden associated
with these variables. This process will
inform areas of improvement prior to
incorporating the new module,
including protocol, forms, and
instructions into NHSN. The estimated
burden for this form is 20 minutes,
which is based on a similar
denominator form. 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
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 April 2020, 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 US 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
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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
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
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 ICR previously approved in
December of 2019 for 5,352,360
responses; 3,113,631 burden hours. The
proposed changes in this new ICR
include revisions to eight data
collection forms and the addition of ten
new forms for a total of 79 proposed
data collection forms. In this Revision,
CDC requests OMB approval for an
estimated 1,321,443 annual burden
hours.
The ICR previously approved in
December of 2019 for 5,352,360
responses; 3,113,631 burden hours and
$101,009,102 in annual cost, is due to
expire on December 31, 2022. The
reporting burden decreased by
1,792,188 hours for a total estimated
burden of 1,321,443 hours. The annual
cost of reporting will increase by
$1,642,524 for a total cost burden of
$102,651,626. The proposed changes in
this new ICR include revisions to eight
data collection forms and the addition
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of two new forms for a total of 79
proposed data collection forms. In this
Revision, CDC requests OMB approval
for an estimated 1,321,443 annual
burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form No. & 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 ......................................................................................
57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table for
monthly electronic upload ............................................................................
57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly
Electronic Upload .........................................................................................
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 ....................................
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Number of
responses per
respondent
Avg. burden
per response
(min./hour)
Total burden
(hours)
2,000
2,000
6,765
1,000
7,821
5,775
1,800
5,463
334
6,000
600
1,100
500
1
1
1
1
12
5
2
8
1
5
91
12
12
5/60
10/60
55/60
5/60
15/60
38/60
30/60
28/60
30/60
20/60
35/60
4/60
5/60
167
333
6,201
83
23,463
18,288
18,288
20,395
167
10,000
31,850
880
503
5,500
6,000
6,000
55
60
9
602
1
5/60
35/60
10/60
28/60
27,665
31,500
602,000
26
2,500
12
5/60
1,500
2,000
500
720
12
213
12
5/60
25/60
30/60
2,000
44,375
3,960
5,500
4,800
50
29
79
250
15/60
20/60
25/60
39,875
126,400
5,208
300
12
5/60
300
300
3,079
1,998
4
1
24
5/60
1/60
12/60
100
51
9,590
1,998
339
2,011
339
130
620
1,340
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
12/60
12/60
12/60
250/60
12/60
10/60
10/60
480/60
5/60
20/60
60/60
15/60
15/60
10/60
85/60
1/60
70/60
10/60
35/60
4,795
814
4,826
814
312
10
625
400
........................
3,333
2,500
375
625
417
708
100
7,000
833
292
500
500
4
4
20/60
20/60
667
667
500
1
20/60
167
500
2
20/60
333
500
4
20/60
667
500
500
1
1
20/60
20/60
167
167
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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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]]>Agencies
[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73713-73716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25576]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled National Healthcare Safety Network (NHSN) 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 June 15, 2020 to obtain
comments from the public and affected agencies. CDC received two
comments related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/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
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666, Exp. 12/31/2022)--Revision--National Center for 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. 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 planned
[[Page 73714]]
Neonatal Component is expected to launch during the winter of 2020/
2021. 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. These
infections are usually serious, causing a prolongation of hospital
stay, increased cost, and risk of morbidity and mortality. 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. A new form has been introduced for field testing--
Respiratory Tract Infection (RTI)--not to be used by NHSN users, but as
part of an EIP project with 4 EIP sites. Form title will be
Denominators for Healthcare Associated Infections (HAIs): Respiratory
Tract Infections. The purpose of this form is to allow testing prior to
introducing a new module and forms to NHSN users. The CDC's
Epidemiology Research & Innovations Branch (ERIB) team will use the
form to perform field testing of variables to explore the utilization,
applicability, and data collection burden associated with these
variables. This process will inform areas of improvement prior to
incorporating the new module, including protocol, forms, and
instructions into NHSN. The estimated burden for this form is 20
minutes, which is based on a similar denominator form. 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 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 April 2020, 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 US 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, long-term 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 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 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 ICR previously approved in December of 2019 for 5,352,360
responses; 3,113,631 burden hours. The proposed changes in this new ICR
include revisions to eight data collection forms and the addition of
ten new forms for a total of 79 proposed data collection forms. In this
Revision, CDC requests OMB approval for an estimated 1,321,443 annual
burden hours.
The ICR previously approved in December of 2019 for 5,352,360
responses; 3,113,631 burden hours and $101,009,102 in annual cost, is
due to expire on December 31, 2022. The reporting burden decreased by
1,792,188 hours for a total estimated burden of 1,321,443 hours. The
annual cost of reporting will increase by $1,642,524 for a total cost
burden of $102,651,626. The proposed changes in this new ICR include
revisions to eight data collection forms and the addition
[[Page 73715]]
of two new forms for a total of 79 proposed data collection forms. In
this Revision, CDC requests OMB approval for an estimated 1,321,443
annual burden hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Form No. & name Number of responses per per response Total burden
respondents respondent (min./hour) (hours)
----------------------------------------------------------------------------------------------------------------
57.100 NHSN Registration Form................... 2,000 1 5/60 167
57.101 Facility Contact Information............. 2,000 1 10/60 333
57.103 Patient Safety Component--Annual Hospital 6,765 1 55/60 6,201
Survey.........................................
57.105 Group Contact Information................ 1,000 1 5/60 83
57.106 Patient Safety Monthly Reporting Plan.... 7,821 12 15/60 23,463
57.108 Primary Bloodstream Infection (BSI)...... 5,775 5 38/60 18,288
57.111 Pneumonia (PNEU)......................... 1,800 2 30/60 18,288
57.112 Ventilator-Associated Event.............. 5,463 8 28/60 20,395
57.113 Pediatric Ventilator-Associated Event 334 1 30/60 167
(PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............ 6,000 5 20/60 10,000
57.115 Custom Event............................. 600 91 35/60 31,850
57.116 Denominators for Neonatal Intensive Care 1,100 12 4/60 880
Unit (NICU)....................................
57.117 Denominators for Specialty Care Area 500 12 5/60 503
(SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit 5,500 60 5/60 27,665
(ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............ 6,000 9 35/60 31,500
57.121 Denominator for Procedure................ 6,000 602 10/60 602,000
57.122 HAI Progress Report State Health 55 1 28/60 26
Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)- 2,500 12 5/60 1,500
Microbiology Data Electronic Upload
Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)- 2,000 12 5/60 2,000
Pharmacy Data Electronic Upload Specification
Tables.........................................
57.125 Central Line Insertion Practices 500 213 25/60 44,375
Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form............... 720 12 30/60 3,960
57.127 MDRO and CDI Prevention Process and 5,500 29 15/60 39,875
Outcome Measures Monthly Monitoring............
57.128 Laboratory-identified MDRO or CDI Event.. 4,800 79 20/60 126,400
57.129 Adult Sepsis............................. 50 250 25/60 5,208
57.135 Late Onset Sepsis/Meningitis Denominator 300 12 5/60 300
Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form: 300 4 5/60 100
Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual 3,079 1 1/60 51
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 1,998 24 12/60 9,590
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 1,998 12 12/60 4,795
Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF... 339 12 12/60 814
57.141 Monthly Reporting Plan for LTCF.......... 2,011 12 12/60 4,826
57.142 Denominators for LTCF Locations.......... 339 12 250/60 814
57.143 Prevention Process Measures Monthly 130 12 12/60 312
Monitoring for LTCF............................
57.150 LTAC Annual Survey....................... 620 1 10/60 10
57.151 Rehab Annual Survey...................... 1,340 1 10/60 625
57.200 Healthcare Personnel Safety Component 50 1 480/60 400
Annual Facility Survey.........................
57.203 Healthcare Personnel Safety Monthly .............. 1 5/60 ..............
Reporting Plan.................................
57.204 Healthcare Worker Demographic Data....... 50 200 20/60 3,333
57.205 Exposure to Blood/Body Fluids............ 50 50 60/60 2,500
57.206 Healthcare Worker Prophylaxis/Treatment.. 50 30 15/60 375
57.207 Follow-Up Laboratory Testing............. 50 50 15/60 625
57.210 Healthcare Worker Prophylaxis/Treatment-- 50 50 10/60 417
Influenza......................................
57.300 Hemovigilance Module Annual Survey....... 500 1 85/60 708
57.301 Hemovigilance Module Monthly Reporting 500 12 1/60 100
Plan...........................................
57.303 Hemovigilance Module Monthly Reporting 500 12 70/60 7,000
Denominators...................................
57.305 Hemovigilance Incident................... 500 10 10/60 833
57.306 Hemovigilance Module Annual Survey--Non- 500 1 35/60 292
acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute 500 4 20/60 667
Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic 500 4 20/60 667
Transfusion Reaction...........................
57.309 Hemovigilance Adverse Reaction--Delayed 500 1 20/60 167
Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed 500 2 20/60 333
Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile 500 4 20/60 667
Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection 500 1 20/60 167
[[Page 73716]]
57.314 Hemovigilance Adverse Reaction--Post 500 1 20/60 167
Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Transfusion Associated Graft vs. Host Disease..
57.317 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction-- 500 2 20/60 333
Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown 500 1 20/60 167
Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other 500 1 20/60 167
Transfusion Reaction...........................
57.400 Outpatient Procedure Component--Annual 700 1 10/60 117
Facility Survey................................
57.401 Outpatient Procedure Component--Monthly 700 12 15/60 2,100
Reporting Plan.................................
57.402 Outpatient Procedure Component--Same Day 200 1 40/60 133
Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly 200 400 40/60 53,333
Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI 700 100 40/60 46,667
Denominator....................................
57.405 Outpatient Procedure Component--Surgical 700 5 40/60 2,333
Site (SSI) Event...............................
57.500 Outpatient Dialysis Center Practices 7,200 1 127/60 15,240
Survey.........................................
57.501 Dialysis Monthly Reporting Plan.......... 7,200 12 5/60 7,200
57.502 Dialysis Event........................... 7,200 30 25/60 90,000
57.503 Denominator for Outpatient Dialysis...... 7,200 30 10/60 14,400
57.504 Prevention Process Measures Monthly 1,730 12 75/60 25,950
Monitoring for Dialysis........................
57.505 Dialysis Patient Influenza Vaccination... 615 50 10/60 5,125
57.506 Dialysis Patient Influenza Vaccination 615 5 10/60 513
Denominator....................................
57.507 Home Dialysis Center Practices Survey.... 430 1 30/60 215
----------------------------------------------------------------------------------------------------------------
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
