Proposed Data Collection Submitted for Public Comment and Recommendations, 52572-52575 [2022-18442]
Download as PDF
<![CDATA[
52572
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
activities of daily living. Yet, adults
with special needs are often required to
have an intellectual disability in order
to qualify for services. This data will
allow investigators to describe the gap
between intellectual ability and daily
living skills in adolescents with ASD to
inform public policies on eligibility for
services. Additionally, because most
SEED 1 participants will reach young
adulthood (i.e., age 18 years) in years
2021–2026, data collected through this
study will provide an opportunity to
assess changes in service access and
utilization that may occur following
high school exit. This period is
particularly challenging for young
adults with ASD who can experience
poor outcomes across multiple domains
(i.e., employment, education, social
engagement, independent living, and
access to health and mental health care
service, in association with the loss of
well-integrated school-based services).
Hence, through surveying SEED 1
participants before and after their
anticipated exit from high school, data
collected through this study could
provide important information on the
loss of services and emerging issues that
can inform service delivery and
programs on the supports needed to
achieve greater independence.
Initial follow-up surveys of SEED
participants will be conducted with the
parents of the children who previously
participated in SEED because it is the
parents who provided consent for
follow-up studies. However, many
emerging issues surrounding the
transition to adulthood among
adolescents with ASD require self rather
than parental report (e.g., self-reported
symptoms of anxiety, depression,
quality of life, social camouflaging,
gender identity, sexuality, and
relationships). Therefore, children who
originally participated at age 2–5 years
who are now adolescents and young
adults, will be contacted through their
parents and asked if they wish to
provide informed consent for
participation in surveys.
CDC requests OMB approval for an
estimated 2,089 annual burden hours.
There are no costs to respondents other
than their time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Caregiver
Caregiver
Caregiver
Caregiver
Caregiver
Caregiver
.............
.............
.............
.............
.............
.............
Caregiver and
Adult Child.
Adult Child ...........
Children aged 8–
22 years and
their caregivers.
Review of enrollment call script and consent for first follow-up survey ....
First follow-up core survey of SEED 1–3 caregivers .................................
First follow-up survey supplement for caregivers of children ....................
First follow-up survey supplement for caregivers of adolescents .............
First follow-up survey supplement for caregivers of young adults ............
Review of enrollment call script and consent, and Second follow-up survey of SEED 1 caregivers.
Review of enrollment call script and consent by caregivers and young
adults.
Second follow-up survey of SEED 1 adult children ...................................
Review of enrollment and informed consent or assent, In-person assessment of intellectual abilities.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–18440 Filed 8–25–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–0666; Docket No. CDC–2022–
0101]
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.
lotter on DSK11XQN23PROD with NOTICES1
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
SUMMARY:
VerDate Sep<11>2014
Number of
respondents
Form name
16:59 Aug 25, 2022
Jkt 256001
government information, invites the
general public and other federal
agencies the opportunity to comment on
a 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).
This collection provides data necessary
to identify problem areas, measure the
progress of prevention efforts, and
ultimately eliminate healthcareassociated infections (HAIs) nationwide.
DATES: CDC must receive written
comments on or before October 25,
2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0101 by any of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
2,057
1,234
411
411
411
350
1
1
1
1
1
1
10/60
40/60
20/60
20/60
20/60
10/60
165
1
10/60
165
229
1
1
30/60
90/60
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
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
E:\FR\FM\26AUN1.SGM
26AUN1
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
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. 1/31/2025)—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
VerDate Sep<11>2014
16:59 Aug 25, 2022
Jkt 256001
currently has six components: Patient
Safety (PS), Healthcare Personnel Safety
(HPS), Biovigilance (BV), Long-Term
Care Facility (LTCF), Outpatient
Procedure (OPC), Dialysis, and Neonatal
Component.
Data reported under the Patient Safety
Component are used to determine the
magnitude of the healthcare-associated
adverse events and trends in the rates of
the events, in the distribution of
pathogens, and in the adherence to
prevention practices. Data will help
detect changes in the epidemiology of
adverse events resulting from new
medical therapies and changing patient
risks. Additionally, reported data is
being used to describe the epidemiology
of antimicrobial use and resistance and
to better understand the relationship of
antimicrobial therapy to this rising
problem. Under the Healthcare
Personnel Safety Component, protocols
and data on events—both positive and
adverse—are used to determine: (1) the
magnitude of adverse events in
healthcare personnel; and (2)
compliance with immunization and
sharps injuries safety guidelines. Under
the Biovigilance Component, data on
adverse reactions and incidents
associated with blood transfusions are
reported and analyzed to provide
national estimates of adverse reactions
and incidents. Under the Long-Term
Care Facility Component, data is
captured from skilled nursing facilities.
Reporting methods under the LTCF
component have been created by using
forms from the PS Component as a
model with modifications to specifically
address the specific characteristics of
LTCF residents and the unique data
needs of these facilities reporting into
NHSN. The Respiratory Tract Infection
(RTI)Form will not to be used by NHSN
users, but as part of an EIP project with
four EIP sites. The Form is titled
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
Dialysis Component offers a simplified
user interface for dialysis users to
streamline their data entry and analysis
processes as well as provide options for
expanding in the future to include
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
52573
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). The Neonatal
Component focuses on premature
neonates and the healthcare associated
events that occur as a result of their
prematurity. This component currently
has one module, which includes Late
Onset-Sepsis and Meningitis.
NHSN has increasingly served as the
operating system for HAI reporting
compliance through legislation
established by the states. As of August
2022, 37 states, the District of Columbia
and the City of Philadelphia,
Pennsylvania have opted to use NHSN
as their primary system for mandated
reporting. Reporting compliance is
completed by healthcare facilities in
their respective jurisdictions, with
emphasis on those states and
municipalities acquiring varying
consequences for failure to use NHSN.
Additionally, healthcare facilities in five
U.S. territories (Puerto Rico, American
Samoa, the U.S. Virgin Islands, Guam,
and the Northern Mariana Islands) are
voluntarily reporting to NHSN.
Additional territories are projected to
follow with similar use of NHSN for
reporting purposes. NHSN’s data is used
to aid in the tracking of HAIs and guide
infection prevention activities/practices
that protect patients.
The Centers for Medicare and
Medicaid Services (CMS) and other
payers use these data to determine
incentives for performance at healthcare
facilities across the U.S. and
surrounding territories, and members of
the public may use some protected data
to inform their selection among
available providers. Each of these
parties is dependent on the
completeness and accuracy of the data.
CDC and CMS work closely and are
fully committed to ensuring complete
and accurate reporting, which are
critical for protecting patients and
guiding national, state, and local
prevention priorities. CMS collects
some HAI data and healthcare personnel
influenza vaccination summary data,
which is done on a voluntary basis as
part of its Fee-for-Service Medicare
quality reporting programs, while others
may report data required by a federal
mandate. Facilities that fail to report
quality measure data are subject to
partial payment reduction in the
applicable Medicare Fee-for-Service
payment system. CMS links their
E:\FR\FM\26AUN1.SGM
26AUN1
52574
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
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.
The ICR was previously approved in
January of 2022 for 5,943,401 responses
and 1,321,991 burden hours. The
proposed changes in this new ICR
include revisions to nine existing data
collection forms. In this Revision, CDC
requests OMB approval for an estimated
1,614,345 annual burden hours.
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 .......................................................................
57.306 Hemovigilance Module Annual Survey—Non-acute care facility ........
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction ............................................................................................................
VerDate Sep<11>2014
16:59 Aug 25, 2022
Jkt 256001
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Avg. burden
per response
(in hours)
Total burden
(in 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
4,000
12
5/60
4,000
4,000
500
720
12
213
11
5/60
25/60
30/60
4,000
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
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
2,011
339
130
620
1,340
50
50
50
50
50
50
500
500
500
500
500
12
36
12
12
12
1
1
1
200
50
30
50
50
1
12
12
10
1
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
35/60
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
292
500
4
20/60
667
E:\FR\FM\26AUN1.SGM
26AUN1
52575
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form number & name
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. 2022–18442 Filed 8–25–22; 8:45 am]
BILLING CODE 4163–18–P
20/60
667
500
1
20/60
167
500
2
20/60
333
500
4
20/60
667
500
500
500
500
1
1
1
1
20/60
20/60
20/60
20/60
167
167
167
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
7,400
7,400
7,400
7,400
1,730
615
615
450
400
100
5
1
12
30
24
12
50
5
1
40/60
40/60
40/60
125/60
5/60
27/60
10/60
75/60
10/60
10/60
36/60
53,333
46,667
2,333
15,417
7,400
99,900
29,600
25,950
5,125
3075
270
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
........................
........................
........................
1,614,345
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–1166; Docket No. CDC–2022–
0100]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
lotter on DSK11XQN23PROD with NOTICES1
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
SUMMARY:
Jkt 256001
PO 00000
Frm 00076
Fmt 4703
Total burden
(in hours)
4
AGENCY:
16:59 Aug 25, 2022
Avg. burden
per response
(in hours)
500
Proposed Data Collection Submitted
for Public Comment and
Recommendations
VerDate Sep<11>2014
Number of
responses per
respondent
Sfmt 4703
government information, invites the
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Poison Center
Collaborations for Public Health
Emergencies. This proposed collection
will allow CDC to quickly characterize
potential exposures identified through
the National Poison Data System
(NPDS), help determine potential risk
factors, identify illnesses related to the
public health emergency, and improve
the public health response to the
incident.
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Pages 52572-52575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18442]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-0666; Docket No. CDC-2022-0101]
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 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). This collection
provides data necessary to identify problem areas, measure the progress
of prevention efforts, and ultimately eliminate healthcare-associated
infections (HAIs) nationwide.
DATES: CDC must receive written comments on or before October 25, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0101 by any of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS 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 www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.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, MS H21-8, Atlanta, Georgia 30329; Telephone: 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
[[Page 52573]]
60-day notice in the Federal Register concerning each proposed
collection of information, including each new proposed collection, each
proposed extension of existing collection of information, and each
reinstatement of previously approved information collection before
submitting the collection to the OMB for approval. To comply with this
requirement, we are publishing this notice of a proposed data
collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
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. 1/31/2025)--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),
Dialysis, and Neonatal Component.
Data reported under the Patient Safety Component are used to
determine the magnitude of the healthcare-associated adverse events and
trends in the rates of the events, in the distribution of pathogens,
and in the adherence to prevention practices. Data will help detect
changes in the epidemiology of adverse events resulting from new
medical therapies and changing patient risks. Additionally, reported
data is being used to describe the epidemiology of antimicrobial use
and resistance and to better understand the relationship of
antimicrobial therapy to this rising problem. Under the Healthcare
Personnel Safety Component, protocols and data on events--both positive
and adverse--are used to determine: (1) the magnitude of adverse events
in healthcare personnel; and (2) compliance with immunization and
sharps injuries safety guidelines. Under the Biovigilance Component,
data on adverse reactions and incidents associated with blood
transfusions are reported and analyzed to provide national estimates of
adverse reactions and incidents. Under the Long-Term Care Facility
Component, data is captured from skilled nursing facilities. Reporting
methods under the LTCF component have been created by using forms from
the PS Component as a model with modifications to specifically address
the specific characteristics of LTCF residents and the unique data
needs of these facilities reporting into NHSN. The Respiratory Tract
Infection (RTI)Form will not to be used by NHSN users, but as part of
an EIP project with four EIP sites. The Form is titled 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 Dialysis
Component offers a simplified user interface for dialysis users to
streamline their data entry and analysis 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). The Neonatal Component
focuses on premature neonates and the healthcare associated events that
occur as a result of their prematurity. This component currently has
one module, which includes Late Onset-Sepsis and Meningitis.
NHSN has increasingly served as the operating system for HAI
reporting compliance through legislation established by the states. As
of August 2022, 37 states, the District of Columbia and the City of
Philadelphia, Pennsylvania have opted to use NHSN as their primary
system for mandated reporting. Reporting compliance is completed by
healthcare facilities in their respective jurisdictions, with emphasis
on those states and municipalities acquiring varying consequences for
failure to use NHSN. Additionally, healthcare facilities in five U.S.
territories (Puerto Rico, American Samoa, the U.S. Virgin Islands,
Guam, and the Northern Mariana Islands) are voluntarily reporting to
NHSN. Additional territories are projected to follow with similar use
of NHSN for reporting purposes. NHSN's data is used to aid in the
tracking of HAIs and guide infection prevention activities/practices
that protect patients.
The Centers for Medicare and Medicaid Services (CMS) and other
payers use these data to determine incentives for performance at
healthcare facilities across the U.S. and surrounding territories, and
members of the public may use some protected data to inform their
selection among available providers. Each of these parties is dependent
on the completeness and accuracy of the data. CDC and CMS work closely
and are fully committed to ensuring complete and accurate reporting,
which are critical for protecting patients and guiding national, state,
and local prevention priorities. CMS collects some HAI data and
healthcare personnel influenza vaccination summary data, which is done
on a voluntary basis as part of its Fee-for-Service Medicare quality
reporting programs, while others may report data required by a federal
mandate. Facilities that fail to report quality measure data are
subject to partial payment reduction in the applicable Medicare Fee-
for-Service payment system. CMS links their
[[Page 52574]]
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.
The ICR was previously approved in January of 2022 for 5,943,401
responses and 1,321,991 burden hours. The proposed changes in this new
ICR include revisions to nine existing data collection forms. In this
Revision, CDC requests OMB approval for an estimated 1,614,345 annual
burden hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Form number & name Number of responses per per response Total burden
respondents respondent (in hours) (in 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)- 4,000 12 5/60 4,000
Microbiology Data Electronic Upload
Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)- 4,000 12 5/60 4,000
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 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.......... 2,011 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
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.................
[[Page 52575]]
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 7,400 1 125/60 15,417
Survey.........................................
57.501 Dialysis Monthly Reporting Plan.......... 7,400 12 5/60 7,400
57.502 Dialysis Event........................... 7,400 30 27/60 99,900
57.503 Denominator for Outpatient Dialysis...... 7,400 24 10/60 29,600
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 3075
Denominator....................................
57.507 Home Dialysis Center Practices Survey.... 450 1 36/60 270
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....................................... .............. .............. .............. 1,614,345
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-18442 Filed 8-25-22; 8:45 am]
BILLING CODE 4163-18-P
