Proposed Data Collection Submitted for Public Comment and Recommendations, 30367-30370 [2024-08597]
Download as PDF
<![CDATA[
30367
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
work in health departments, community
health centers, clinics, or communitybased organizations.
The purpose of this data collection is
to: (a) assess the awareness and use of
the HIV self-testing and HIV testing
guidelines by healthcare providers
working in different health settings; (b)
understand the barriers and facilitators
to uptake of guidelines; and (c) inform
CDC efforts to support guideline
implementation through training,
promotion, or technical assistance. The
new HIV self-testing guideline and
updated HIV testing guideline are yet to
be published. This project is the first
attempt to evaluate these guidelines and
interview or survey. These data may
inform prevention program
development and monitoring, resource
allocation, and technical assistance
needs at both the local and national
levels. CDC estimates that this data
collection will involve, 1100 surveys
and 120 interviews in specific settings
(community health centers, health
departments, private clinics, public
clinics, hospitals, and community-based
organizations) over the course of three
years. CDC requests OMB approval for
an estimated 610 annual burden hours.
Participation of respondents is
voluntary and there is no cost to the
respondents other than their time.
as such, no other Federal agency
systematically collects this type of
information from healthcare providers
that supply HIV testing services. This
data collection will allow DHP to
understand how guidelines are being
implemented in the early days of release
and inform efforts including resource
allocation for guideline development,
translation, and implementation efforts.
CDC requests approval for a three-year
information collection. Data are
collected through surveys and virtual or
phone interviews conducted with
healthcare providers. There is no
monetary compensation or incentives
provided for participation in the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Eligible Providers ..............................
Eligible Providers ..............................
Survey ..............................................
Interview Questionnaire ...................
1,100
120
1
1
30/60
30/60
550
60
Total ...........................................
..........................................................
........................
........................
........................
610
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–08594 Filed 4–22–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–0666; Docket No. CDC–2024–
0030]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled National Healthcare Safety
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
Network (NHSN). 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.
DATES: CDC must receive written
comments on or before June 24, 2024.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0030 by either 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;
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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
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;
E:\FR\FM\23APN1.SGM
23APN1
30368
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
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.
ddrumheller on DSK120RN23PROD with NOTICES1
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB Control No. 0920–0666,
Exp. 12/31/2026)—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 eight components: Patient
Safety (PS), Healthcare Personnel Safety
(HPS), Biovigilance (BV), Long-Term
Care Facility (LTCF), Outpatient
Procedure (OPC), Dialysis, Neonatal,
and Medication Safety 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
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
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
Form (RTI)—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 because of their
prematurity. This component currently
has one module, which includes Late
Onset-Sepsis and Meningitis. The
Medication Safety Component tracks
medication safety and adverse drug
events that are among the most common
causes of iatrogenic harm in U.S.
hospitals.
NHSN has increasingly served as the
operating system for HAI reporting
compliance through legislation
established by the States. As of July
2023, 37 States, the District of Columbia
and the City of Philadelphia,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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
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
E:\FR\FM\23APN1.SGM
23APN1
30369
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
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
March 2024 for 2,433,165 burden hours.
The proposed changes in this new ICR
include revisions to 80 existing data
collection forms and three new forms. In
this Revision, CDC requests OMB
approval for an estimated annual
burden 3,635,534 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
ddrumheller on DSK120RN23PROD with NOTICES1
57.100 NHSN Registration Form ..................................................................
57.101 Facility Contact Information ..............................................................
57.103 Patient Safety Component—Annual Hospital Survey .......................
57.104 NHSN 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 (VAE) ...................................................
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 ......................................................................................
57.132 Patient Safety Component Digital Measure Reporting Plan (HOB,
HT–CDI, VTE, Adult Sepsis, RPS, NVAP)—IT Initial Set up ......................
57.132 Patient Safety Component Digital Measure Reporting Plan (HOB,
HT–CDI, VTE, Adult Sepsis, RPS, NVAP)—IT Yearly Maintenance ..........
57.132 Patient Safety Component Digital Measure Reporting Plan (HOB,
HT–CDI, VTE, Adult Sepsis, RPS, NVAP)—Infection Preventionist ...........
57.132 Patient Safety Digital Reporting Plan (RPS CSV) ............................
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 ...........
57.144 Resident Respiratory Pathogens Even Form ...................................
57.145 Long Term Care Antimicrobial Use (LTC–AU) Module CDA ...........
57.150 LTAC Annual Survey ........................................................................
57.151 Rehab Annual Survey .......................................................................
57.204 Healthcare Worker Demographic Data .............................................
57.211 Weekly Healthcare Personnel Influenza Vaccination Cumulative
Summary for Non-Long-Term Care Facilities ..............................................
57.214 Annual Healthcare Personnel Influenza Vaccination Summary .......
57.215 Seasonal Survey on Influenza Vaccination Programs for
Healthcare Personnel ...................................................................................
57.300 Hemovigilance Module Annual Survey .............................................
57.301 Hemovigilance Module Monthly Reporting Plan ...............................
57.302 Hemovigilance Module Monthly Incident Summary ..........................
57.303 Hemovigilance Module Monthly Reporting Denominators ................
57.305 Hemovigilance Incident .....................................................................
57.306 Hemovigilance Module Annual Survey—Non-acute care facility ......
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion
Reaction .......................................................................................................
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction ..
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
PO 00000
Number of
responses per
respondent
Avg. burden
per response
(min./hour 60)
2,000
2,000
5,400
800
1,000
7,821
6,000
1,800
5,463
334
6,000
600
1,100
500
1
1
1
1
1
12
12
2
8
1
12
91
12
12
5/60
10/60
137/60
5/60
5/60
15/60
30/60
29/60
28/60
31/60
20/60
35/60
240/60
300/60
167
333
12,330
67
83
23,463
36,000
1,740
20,395
173
24,000
31,850
52,800
30,000
5,500
3,800
3,800
55
60
12
12
1
300/60
11/60
11/60
50/60
1,650,000
8,360
8,360
46
5,500
12
5/60
5,500
5,500
500
720
12
213
12
5/60
26/60
30/60
5,500
46,150
4,320
5,500
4,800
50
29
12
12
15/60
20/60
25/60
39,875
19,200
250
5,500
1
1,620/60
148,500
5,500
1
1,200/60
110,000
5,500
5,500
6,270
286
4
365
1
24
10/60
2/60
128/60
20/60
3,667
66,917
13,376
2,288
738
373
546
724
434
16,500
16,500
395
395
50
12
24
12
12
12
24
12
1
1
200
10/60
35/60
5/60
35/60
5/60
25/60
5/60
102/60
102/60
20/60
1,476
5,222
546
5,068
434
165,000
16,500
672
672
3,333
8,000
22,000
8
1
60/60
120/60
64,000
44,000
15,426
63
108
9
102
13
20
1
1
12
12
12
77
1
45/60
85/60
1/60
30/60
70/60
10/60
35/60
11,570
89
22
54
1,428
167
12
8
50
2
11
20/60
20/60
5
183
Number of
respondents
Form number & name
Frm 00050
Fmt 4703
Sfmt 4703
E:\FR\FM\23APN1.SGM
23APN1
Total burden
(hours)
30370
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Avg. burden
per response
(min./hour 60)
9
2
20/60
6
19
5
20/60
32
85
13
20/60
368
23
2
1
3
2
1
20/60
20/60
20/60
23
1
0.33
18
3
20/60
18
1
1
20/60
0.33
1
1
20/60
0.33
40
15
39
4
3
3
21/60
20/60
20/60
56
15
39
350
350
50
1
12
1
10/60
10/60
40/60
58
700
33
50
300
300
2,500
6,900
7,400
7,400
7,400
1,730
550
400
100
36
12
1
12
30
12
12
1
20/60
20/60
40/60
300/60
150/60
5/60
50/60
10/60
60/60
65/60
6,667
10,000
7,200
150,000
17,250
7,400
185,000
14,800
20,760
596
5,500
1
1620/60
148,500
5,500
1
1,200/60
110,000
5,500
6
6/60
3,300
5,500
12
2/60
2,200
300
6
5/60
150
300
6
6/60
180
5,500
1
1,620/60
148,500
5,500
1
1,200/60
110,000
5,500
10
5,500
4
1
4
10/60
120/60
5/60
3,667
20
1,833
........................
........................
........................
3,635,534
Number of
respondents
Form number & name
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 Ambulatory Surgery
Center Survey ..............................................................................................
57.401 Outpatient Procedure Component—Monthly Reporting Plan ...........
57.402 Outpatient Procedure Component Same Day Outcome Measures
57.403 Outpatient Procedure Component—Denominators for Same Day
Outcome Measures ......................................................................................
57.404 Outpatient Procedure Component—SSI Denominator .....................
57.405 Outpatient Procedure Component—Surgical Site (SSI) Event .........
57.408 Monthly Survey Patient Days & Nurse Staffing ................................
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 .......
57.507 Home Dialysis Center Practices Survey ...........................................
57.600 Neonatal Component FHIR Measure—Late Onset Sepsis Meningitis (LOSMEN) Module—IT Initial Set up ...................................................
57.600 Neonatal Component FHIR Measure—Late Onset Sepsis Meningitis (LOSMEN) Module—IT Yearly Maintenance .......................................
57.600 Neonatal Component FHIR Measure—Late Onset Sepsis Meningitis (LOSMEN) Module—Infection Preventionist ........................................
57.600 Neonatal Component Late Onset Sepsis Meningitis (LOSMEN)
Module CDA Data Collection—Infection Preventionist ................................
57.601 Late Onset Sepsis/Meningitis Denominator Form: Late Onset Sepsis/Meningitis Denominator Form: Data Table for monthly electronic
upload ...........................................................................................................
57.602 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly
Electronic Upload .........................................................................................
57.700 Medication Safety—Digital Measure Reporting Plan (HYPO, HAKI,
ORAE)—IT Initial Set up ..............................................................................
57.700 Medication Safety—Digital Measure Reporting Plan (HYPO, HAKI,
ORAE)—IT Yearly Maintenance ..................................................................
57.700 Medication Safety—Digital Measure Reporting Plan (HYPO, HAKI,
ORAE)—Infection Preventionist ...................................................................
57.701 Glycemic Control Module—HYPO Annual Survey ...........................
Billing Code Data: 837I Upload .......................................................................
ddrumheller on DSK120RN23PROD with NOTICES1
Total ..........................................................................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–08597 Filed 4–22–24; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
PO 00000
Frm 00051
Fmt 4703
Sfmt 9990
E:\FR\FM\23APN1.SGM
23APN1
Total burden
(hours)
]]>Agencies
[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30367-30370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08597]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-0666; Docket No. CDC-2024-0030]
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 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.
DATES: CDC must receive written comments on or before June 24, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0030 by either 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 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;
[[Page 30368]]
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. 12/31/2026)--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 eight components:
Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance
(BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC),
Dialysis, Neonatal, and Medication Safety 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 Form (RTI)--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 because of their prematurity. This component currently has one
module, which includes Late Onset-Sepsis and Meningitis. The Medication
Safety Component tracks medication safety and adverse drug events that
are among the most common causes of iatrogenic harm in U.S. hospitals.
NHSN has increasingly served as the operating system for HAI
reporting compliance through legislation established by the States. As
of July 2023, 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 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
[[Page 30369]]
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 March 2024 for 2,433,165 burden
hours. The proposed changes in this new ICR include revisions to 80
existing data collection forms and three new forms. In this Revision,
CDC requests OMB approval for an estimated annual burden 3,635,534
hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Form number & name Number of responses per per response Total burden
respondents respondent (min./hour 60) (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 5,400 1 137/60 12,330
Survey.........................................
57.104 NHSN Facility Administrator Change 800 1 5/60 67
Request 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)...... 6,000 12 30/60 36,000
57.111 Pneumonia (PNEU)......................... 1,800 2 29/60 1,740
57.112 Ventilator-Associated Event (VAE)........ 5,463 8 28/60 20,395
57.113 Pediatric Ventilator-Associated Event 334 1 31/60 173
(PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............ 6,000 12 20/60 24,000
57.115 Custom Event............................. 600 91 35/60 31,850
57.116 Denominators for Neonatal Intensive Care 1,100 12 240/60 52,800
Unit (NICU)....................................
57.117 Denominators for Specialty Care Area 500 12 300/60 30,000
(SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit 5,500 60 300/60 1,650,000
(ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............ 3,800 12 11/60 8,360
57.121 Denominator for Procedure................ 3,800 12 11/60 8,360
57.122 HAI Progress Report State Health 55 1 50/60 46
Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)-- 5,500 12 5/60 5,500
Microbiology Data Electronic Upload
Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)-- 5,500 12 5/60 5,500
Pharmacy Data Electronic Upload Specification
Tables.........................................
57.125 Central Line Insertion Practices 500 213 26/60 46,150
Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form............... 720 12 30/60 4,320
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 12 20/60 19,200
57.129 Adult Sepsis............................. 50 12 25/60 250
57.132 Patient Safety Component Digital Measure 5,500 1 1,620/60 148,500
Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
RPS, NVAP)--IT Initial Set up..................
57.132 Patient Safety Component Digital Measure 5,500 1 1,200/60 110,000
Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
RPS, NVAP)--IT Yearly Maintenance..............
57.132 Patient Safety Component Digital Measure 5,500 4 10/60 3,667
Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
RPS, NVAP)--Infection Preventionist............
57.132 Patient Safety Digital Reporting Plan 5,500 365 2/60 66,917
(RPS CSV)......................................
57.137 Long-Term Care Facility Component--Annual 6,270 1 128/60 13,376
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 286 24 20/60 2,288
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 738 12 10/60 1,476
Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF... 373 24 35/60 5,222
57.141 Monthly Reporting Plan for LTCF.......... 546 12 5/60 546
57.142 Denominators for LTCF Locations.......... 724 12 35/60 5,068
57.143 Prevention Process Measures Monthly 434 12 5/60 434
Monitoring for LTCF............................
57.144 Resident Respiratory Pathogens Even Form. 16,500 24 25/60 165,000
57.145 Long Term Care Antimicrobial Use (LTC-AU) 16,500 12 5/60 16,500
Module CDA.....................................
57.150 LTAC Annual Survey....................... 395 1 102/60 672
57.151 Rehab Annual Survey...................... 395 1 102/60 672
57.204 Healthcare Worker Demographic Data....... 50 200 20/60 3,333
57.211 Weekly Healthcare Personnel Influenza 8,000 8 60/60 64,000
Vaccination Cumulative Summary for Non-Long-
Term Care Facilities...........................
57.214 Annual Healthcare Personnel Influenza 22,000 1 120/60 44,000
Vaccination Summary............................
57.215 Seasonal Survey on Influenza Vaccination 15,426 1 45/60 11,570
Programs for Healthcare Personnel..............
57.300 Hemovigilance Module Annual Survey....... 63 1 85/60 89
57.301 Hemovigilance Module Monthly Reporting 108 12 1/60 22
Plan...........................................
57.302 Hemovigilance Module Monthly Incident 9 12 30/60 54
Summary........................................
57.303 Hemovigilance Module Monthly Reporting 102 12 70/60 1,428
Denominators...................................
57.305 Hemovigilance Incident................... 13 77 10/60 167
57.306 Hemovigilance Module Annual Survey--Non- 20 1 35/60 12
acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute 8 2 20/60 5
Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic 50 11 20/60 183
Transfusion Reaction...........................
[[Page 30370]]
57.309 Hemovigilance Adverse Reaction--Delayed 9 2 20/60 6
Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed 19 5 20/60 32
Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile 85 13 20/60 368
Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction-- 23 3 20/60 23
Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection 2 2 20/60 1
57.314 Hemovigilance Adverse Reaction--Post 1 1 20/60 0.33
Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction-- 18 3 20/60 18
Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction-- 1 1 20/60 0.33
Transfusion Associated Graft vs. Host Disease..
57.317 Hemovigilance Adverse Reaction-- 1 1 20/60 0.33
Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction-- 40 4 21/60 56
Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown 15 3 20/60 15
Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other 39 3 20/60 39
Transfusion Reaction...........................
57.400 Outpatient Procedure Component -- Annual 350 1 10/60 58
Ambulatory Surgery Center Survey...............
57.401 Outpatient Procedure Component--Monthly 350 12 10/60 700
Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day 50 1 40/60 33
Outcome Measures...............................
57.403 Outpatient Procedure Component-- 50 400 20/60 6,667
Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI 300 100 20/60 10,000
Denominator....................................
57.405 Outpatient Procedure Component--Surgical 300 36 40/60 7,200
Site (SSI) Event...............................
57.408 Monthly Survey Patient Days & Nurse 2,500 12 300/60 150,000
Staffing.......................................
57.500 Outpatient Dialysis Center Practices 6,900 1 150/60 17,250
Survey.........................................
57.501 Dialysis Monthly Reporting Plan.......... 7,400 12 5/60 7,400
57.502 Dialysis Event........................... 7,400 30 50/60 185,000
57.503 Denominator for Outpatient Dialysis...... 7,400 12 10/60 14,800
57.504 Prevention Process Measures Monthly 1,730 12 60/60 20,760
Monitoring for Dialysis........................
57.507 Home Dialysis Center Practices Survey.... 550 1 65/60 596
57.600 Neonatal Component FHIR Measure--Late 5,500 1 1620/60 148,500
Onset Sepsis Meningitis (LOSMEN) Module--IT
Initial Set up.................................
57.600 Neonatal Component FHIR Measure--Late 5,500 1 1,200/60 110,000
Onset Sepsis Meningitis (LOSMEN) Module--IT
Yearly Maintenance.............................
57.600 Neonatal Component FHIR Measure--Late 5,500 6 6/60 3,300
Onset Sepsis Meningitis (LOSMEN) Module--
Infection Preventionist........................
57.600 Neonatal Component Late Onset Sepsis 5,500 12 2/60 2,200
Meningitis (LOSMEN) Module CDA Data Collection--
Infection Preventionist........................
57.601 Late Onset Sepsis/Meningitis Denominator 300 6 5/60 150
Form: Late Onset Sepsis/Meningitis Denominator
Form: Data Table for monthly electronic upload.
57.602 Late Onset Sepsis/Meningitis Event Form: 300 6 6/60 180
Data Table for Monthly Electronic Upload.......
57.700 Medication Safety--Digital Measure 5,500 1 1,620/60 148,500
Reporting Plan (HYPO, HAKI, ORAE)--IT Initial
Set up.........................................
57.700 Medication Safety--Digital Measure 5,500 1 1,200/60 110,000
Reporting Plan (HYPO, HAKI, ORAE)--IT Yearly
Maintenance....................................
57.700 Medication Safety--Digital Measure 5,500 4 10/60 3,667
Reporting Plan (HYPO, HAKI, ORAE)--Infection
Preventionist..................................
57.701 Glycemic Control Module--HYPO Annual 10 1 120/60 20
Survey.........................................
Billing Code Data: 837I Upload.................. 5,500 4 5/60 1,833
---------------------------------------------------------------
Total....................................... .............. .............. .............. 3,635,534
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-08597 Filed 4-22-24; 8:45 am]
BILLING CODE 4163-18-P
