Proposed Data Collection Submitted for Public Comment and Recommendations, 53309-53312 [2021-20846]
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53309
Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Cigarette smoking is the leading
preventable cause of premature death
and disability in our nation. Each year
more than 480,000 deaths occur as the
result of cigarette smoking-related
diseases. The CDC’s Office on Smoking
and Health (OSH) is the lead federal
agency for comprehensive tobacco
prevention and control. Since 1986, as
required by the Comprehensive
Smoking Education Act (CSEA) of 1984,
which amended the Federal Cigarette
Labeling and Advertising Act (FCLAA),
15 U.S.C. 1335a, CDC has collected
information about the ingredients used
in cigarette products. HHS has delegated
responsibility for implementing the
required information collection to CDC’s
OSH. Respondents are commercial
cigarette manufacturers, packagers, or
importers (or their representatives), who
Attention: FCLAA Program Manager,
Office on Smoking and Health, National
Center for Chronic Disease Prevention
and Health Promotion, Centers for
Disease Control and Prevention, 4770
Buford Highway NE, MS S107–7,
Atlanta, GA 30341–3717.
Upon receipt and verification of the
annual ingredient report, CDC issues a
Certificate of Compliance to the
respondent. As deemed appropriate by
the Secretary of HHS, HHS is authorized
to use the information to report to
Congress the health effects of
ingredients, research activities related to
the health effects of ingredients, and
other information that the Secretary
determines to be of public interest.
There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
358. OMB approval is requested for
three years.
are required by FCLAA to submit
ingredient reports to HHS on an annual
basis.
Respondents are not required to
submit specific forms; however, they are
required to submit a list of all
ingredients used in their products. CDC
requires the ingredient report to be
submitted by chemical name and
Chemical Abstract Service (CAS)
Registration Number, consistent with
accepted reporting practices for other
companies currently required to report
ingredients added to other consumer
products. The information collected is
subject to strict confidentiality
provisions.
Ingredient reports are due annually on
March 31. Information is submitted to
CDC by mailing or faxing a written
report on the respondent’s letterhead.
All faxed lists should be followed up
with a mailed original. Electronic mail
submissions are not accepted. Mail
Annual Ingredient Submissions to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Business Entities ...............................
N/A ...................................................
55
1
6.5
358
Total ...........................................
...........................................................
........................
........................
........................
358
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–20844 Filed 9–24–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–0666; Docket No. CDC–2021–
0100]
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.
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
SUMMARY:
VerDate Sep<11>2014
18:08 Sep 24, 2021
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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 the nation’s
most widely used healthcare-associated
infection tracking system, providing
facilities, states, regions, and the nation
with data needed to identify problem
areas, measure progress of prevention
efforts, and ultimately eliminate
healthcare-associated infections.
DATES: CDC must receive written
comments on or before November 26,
2021.
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,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop H21–8, Atlanta, Georgia 30329;
phone: 404–639–7570; Email: omb@
cdc.gov.
You may submit comments,
identified by Docket No. CDC–2020–
0100 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, Mailstop H21–8,
Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
SUPPLEMENTARY INFORMATION:
ADDRESSES:
AGENCY:
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Number of
respondents
Type of respondents
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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
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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
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;
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; and
5. Assess information collection costs.
lotter on DSK11XQN23PROD with NOTICES1
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB Control No. 0920–0666,
Exp. 12/31/2023)—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) (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 2021, and
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 OnsetSepsis (LOS) and Meningitis. LOS and
Meningitis are common complications
of extreme prematurity. These infections
result in a prolongation of hospital stay,
increased cost, and risk of morbidity
and mortality. The data for this module
will be electronically submitted,
allowing more hospital personnel to be
available to care for patients and
reducing 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
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 (HPS), 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.
The Biovigilance (BV) Component
collects data on adverse reactions and
incidents associated with blood
transfusions. Data is reported and
analyzed to provide national estimates
of adverse reactions and incidents.
Under the Long-Term Care Facility
(LTCF) 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 Respiratory Tract Infection Form
(RTI), titled ‘‘Denominators for
Healthcare Associated Infections (HAIs):
Respiratory Tract Infections,’’ will not to
be used by NHSN users, but rather as
part of an EIP project with 4 EIP sites.
The purpose of this form is to allow
testing prior to introducing a new
module and forms to NHSN users. The
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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 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 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,
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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.
NHSN was previously approved in
December 2020 for 1,321,991 burden
hours. The proposed changes in this
new ICR include revisions to 10 data
collection forms and no new forms for
a total of 86 proposed data collection
forms. In this Revision, CDC requests
OMB approval for an estimated
1,718,591 annual burden hours.
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
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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Form number & name
57.100 NHSN Registration Form ..................................................................
57.101 Facility Contact Information ..............................................................
57.103 Patient Safety Component—Annual Hospital Survey .......................
57.104 Facility Administrator Change Request Form ...................................
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 ...
57.204 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 .....................................................................
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Number of
responses per
respondent
Avg. burden
per response
(hours)
Total burden
(hours)
2,000
2,000
6,765
800
1,000
7,821
5,775
1,800
5,463
334
6,000
600
1,100
500
1
1
1
1
1
12
5
2
8
1
5
91
12
12
5/60
10/60
90/60
5/60
5/60
15/60
38/60
30/60
28/60
30/60
20/60
35/60
4/60
5/60
167
333
10,148
67
83
23,463
18,288
1,800
20,395
167
10,000
31,850
880
500
5,500
6,000
6,000
55
60
9
602
1
5/60
35/60
10/60
28/60
27,500
31,500
602,000
26
2,500
12
5/60
2,500
2,500
500
720
12
213
11
5/60
25/60
30/60
2,500
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
6
5/60
150
300
17,700
1,998
6
1
24
5/60
120/60
20/60
150
35,400
15,984
1,998
339
2011
339
130
620
1,340
50
50
50
50
50
50
500
500
500
500
12
36
12
12
12
1
1
1
200
50
30
50
50
1
12
12
10
20/60
35/60
5/60
35/60
5/60
82/60
82/60
480/60
20/60
60/60
15/60
15/60
10/60
85/60
60/60
70/60
10/60
7,992
7,119
2,011
2,373
130
847
1,831
400
3,333
2,500
375
625
417
708
6,000
7,000
833
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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form number & name
57.306 Hemovigilance Module Annual Survey—Non-acute care facility ......
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion
Reaction .......................................................................................................
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction ..
57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion
Reaction .......................................................................................................
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion
Reaction .......................................................................................................
57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction ............................................................................................
57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction ................................................................................................................
57.313 Hemovigilance Adverse Reaction—Infection ....................................
57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura ........
57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea ...............................................................................................................
57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft
vs. Host Disease ..........................................................................................
57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute
Lung Injury ...................................................................................................
57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload .........................................................................................
57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction .....
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 ...........................................
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary
for Non-Long-Term Care Facilities ...............................................................
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary
for Long-Term Care Facilities ......................................................................
Weekly Resident Influenza Vaccination Cumulative Summary for Long-Term
Care Facilities ..............................................................................................
Annual Healthcare Personnel Influenza Vaccination Summary ......................
Total ..........................................................................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–20846 Filed 9–24–21; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4163–18–P
35/60
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
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
7,200
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
12/60
5/60
25/60
10/60
75/60
10/60
10/60
30/60
53,333
46,667
2,333
1,440
7,200
90,000
36000
25,950
5,125
513
215
125
52
60/60
6,500
1,200
52
60/60
62,400
2,500
5,000
52
1
60/60
120/60
130,000
10,000
........................
........................
........................
1,718,591
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to the Clinical Laboratory
Improvement Advisory Committee
(CLIAC)
Notice.
The Centers for Disease
Control and Prevention (CDC) is seeking
nominations for membership on the
CLIAC. The CLIAC consists of 20
experts including the Chair, represents
18:08 Sep 24, 2021
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Total burden
(hours)
1
SUMMARY:
VerDate Sep<11>2014
Avg. burden
per response
(hours)
500
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Number of
responses per
respondent
Sfmt 4703
a diverse membership across laboratory
specialties, professional roles
(laboratory management, technical
specialists, physicians, nurses) and
practice settings (academic, clinical,
public health), and includes a consumer
representative.
DATES: Nominations for membership on
CLIAC must be received no later than
March 1, 2022. Packages received after
this time will not be considered for the
current membership cycle.
ADDRESSES: All nominations should be
mailed to Nancy Anderson, MMSc,
MT(ASCP), CLIAC Secretary, Senior
Advisor for Clinical Laboratories,
Division of Laboratory Systems, Center
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]]>Agencies
[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53309-53312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20846]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-21-0666; Docket No. CDC-2021-0100]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled National Healthcare Safety
Network (NHSN). NHSN is the nation's most widely used healthcare-
associated infection tracking system, providing facilities, states,
regions, and the nation with data needed to identify problem areas,
measure progress of prevention efforts, and ultimately eliminate
healthcare-associated infections.
DATES: CDC must receive written comments on or before November 26,
2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0100 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, Mailstop H21-8, 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, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, Mailstop H21-8, 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
[[Page 53310]]
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;
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; and
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666, Exp. 12/31/2023)--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) (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 Neonatal Component is expected to launch during the winter of
2021, and 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 (LOS) and Meningitis. LOS and Meningitis are common
complications of extreme prematurity. These infections result in a
prolongation of hospital stay, increased cost, and risk of morbidity
and mortality. The data for this module will be electronically
submitted, allowing more hospital personnel to be available to care for
patients and reducing 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 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 (HPS), 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.
The Biovigilance (BV) Component collects data on adverse reactions
and incidents associated with blood transfusions. Data is reported and
analyzed to provide national estimates of adverse reactions and
incidents.
Under the Long-Term Care Facility (LTCF) 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 Respiratory Tract Infection Form
(RTI), titled ``Denominators for Healthcare Associated Infections
(HAIs): Respiratory Tract Infections,'' will not to be used by NHSN
users, but rather as part of an EIP project with 4 EIP sites. 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 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 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,
[[Page 53311]]
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.
NHSN was previously approved in December 2020 for 1,321,991 burden
hours. The proposed changes in this new ICR include revisions to 10
data collection forms and no new forms for a total of 86 proposed data
collection forms. In this Revision, CDC requests OMB approval for an
estimated 1,718,591 annual burden hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Form number & name Number of responses per per response Total burden
respondents respondent (hours) (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 90/60 10,148
Survey.........................................
57.104 Facility Administrator Change Request 800 1 5/60 67
Form...........................................
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 1,800
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 5/60 500
(SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit 5,500 60 5/60 27,500
(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 2,500
Microbiology Data Electronic Upload
Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)-- 2,500 12 5/60 2,500
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 11 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 6 5/60 150
Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form: 300 6 5/60 150
Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual 17,700 1 120/60 35,400
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 1,998 24 20/60 15,984
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 1,998 12 20/60 7,992
Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF... 339 36 35/60 7,119
57.141 Monthly Reporting Plan for LTCF.......... 2011 12 5/60 2,011
57.142 Denominators for LTCF Locations.......... 339 12 35/60 2,373
57.143 Prevention Process Measures Monthly 130 12 5/60 130
Monitoring for LTCF............................
57.150 LTAC Annual Survey....................... 620 1 82/60 847
57.151 Rehab Annual Survey...................... 1,340 1 82/60 1,831
57.200 Healthcare Personnel Safety Component 50 1 480/60 400
Annual Facility Survey.........................
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 60/60 6,000
Plan...........................................
57.303 Hemovigilance Module Monthly Reporting 500 12 70/60 7,000
Denominators...................................
57.305 Hemovigilance Incident................... 500 10 10/60 833
[[Page 53312]]
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
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 12/60 1,440
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 36000
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
Weekly Healthcare Personnel Influenza 125 52 60/60 6,500
Vaccination Cumulative Summary for Non-Long-
Term Care Facilities...........................
Weekly Healthcare Personnel Influenza 1,200 52 60/60 62,400
Vaccination Cumulative Summary for Long-Term
Care Facilities................................
Weekly Resident Influenza Vaccination Cumulative 2,500 52 60/60 130,000
Summary for Long-Term Care Facilities..........
Annual Healthcare Personnel Influenza 5,000 1 120/60 10,000
Vaccination Summary............................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1,718,591
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-20846 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P
