Proposed Data Collection Submitted for Public Comment and Recommendations, 56827-56830 [2023-17924]
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56827
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
benchmarking to national data); private
research and action organizations
focused on men’s and women’s health,
child well-being, and marriage and the
family; academic researchers in the
social and public health sciences;
journalists, and many others.
This submission requests approval for
a revision to NSFG data collection for
three years. The revision request
includes the increase of the main survey
incentive from $40 to $60, a small set
of questionnaire revisions beginning in
Year 3 (2024) data collection and to
conduct several methodological studies
designed to improve the efficiency and
validity of NSFG data collection for the
purposes described above. The total
estimated annualized time burden to
respondents is 6,584 hours. There is no
cost to respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN HOURS
Respondents
Household
Household
Household
Household
Household
member .........................................
Female 15–49 years of age .........
Male 15–49 years of age .............
member .........................................
Individual 15–49 years of age ......
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. 2023–17920 Filed 8–18–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–0666; Docket No. CDC–2023–
0068]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice with comment period.
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
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).
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.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
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Number of
responses
Form
Jkt 259001
Screener Interview .........................................
Female Interview ............................................
Male Interview ................................................
Screener Verification ......................................
Main Verification .............................................
CDC must receive written
comments on or before October 20,
2023.
DATES:
You may submit comments,
identified by Docket No. CDC–2023–
0068 by either of the following methods:
• Federal eRulemaking Portal:
ww.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: 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
ADDRESSES:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Average
burden/
response
(in hours)
Responses
per
respondent
15,000
2,750
2,250
230
150
1
1
1
1
1
5/60
75/60
50/60
2/60
5/60
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. 6/30/2026)—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
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Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC) collects
data from healthcare facilities in the
National Healthcare Safety Network
(NHSN) (OMB Control No. 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 seven 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 PS
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 HPS 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 BV 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 LTCF Component, data is
captured from skilled nursing facilities.
Reporting methods under the LTCF
component have been created by using
forms from the PS Component as a
model with modifications to specifically
address the specific characteristics of
LTCF residents and the unique data
needs of these facilities reporting into
NHSN. The Respiratory Tract Infection
Form (RTI)—will not to be used by
NHSN users, but as part of an EIP
project with four EIP sites. The Form is
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18:17 Aug 18, 2023
Jkt 259001
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 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
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Sfmt 4703
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
National Nursing Home Quality
Collaborative, which focuses on
recruiting nursing homes to report HAI
data to NHSN and to retain their
continued participation.
The NHSN data collection was
previously approved in June of 2023 for
6,209,922 responses and 1,693,215
annual burden hours. The proposed
changes in this Revision include
modifications to 15 existing data
collection forms and one new form. CDC
requests OMB approval for an estimated
annual burden 1,524,039 hours. There is
no cost to respondents other than their
time to participate.
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Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
ddrumheller on DSK120RN23PROD 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 ............................................................................................................
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 ................................................................................................
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Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(min./hour)
Total burden
(hours)
2,000
2,000
5,311
800
1,000
6,387
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
135/60
5/60
5/60
15/60
38/60
30/60
28/60
30/60
20/60
35/60
4/60
5/60
167
333
11,950
67
83
19,161
18,288
1800
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
5,500
12
5/60
5,500
5,500
500
720
12
213
11
5/60
25/60
30/60
5,500
44,375
3,960
5,500
4,800
50
29
79
250
15/60
20/60
25/60
39,875
126,400
5,208
300
6
5/60
150
300
17,700
1,086
6
1
24
5/60
122/60
20/60
150
35,990
8,688
1,019
339
1,099
714
357
392
1,160
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
15/60
35/60
5/60
89/60
89/60
480/60
20/60
60/60
15/60
15/60
10/60
85/60
60/60
70/60
10/60
35/60
4,076
7,119
3,297
4,998
357
581
1,721
400
3,333
2,500
375
625
417
708
6,000
7,000
833
292
500
500
4
4
20/60
20/60
667
667
500
1
20/60
167
500
2
20/60
333
500
4
20/60
667
500
500
500
500
1
1
1
1
20/60
20/60
20/60
20/60
167
167
167
167
500
1
20/60
167
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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form number & name
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 ......................
Healthcare-facility onset, antibiotic-treated Clostridioides difficile (C. difficile)
Infection (HT–CDI) Event Module Annual Reporting Plan ..........................
Total Estimated Annual Burden Hours .....................................................
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. 2023–17924 Filed 8–18–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to the Board of Scientific
Counselors, National Center for Health
Statistics
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), is seeking nominations
for membership on the Board of
Scientific Counselors, National Center
for Health Statistics (BSC, NCHS). The
SUMMARY:
VerDate Sep<11>2014
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Jkt 259001
Frm 00039
Fmt 4703
Average
burden per
response
(min./hour)
Total burden
(hours)
500
1
20/60
167
500
500
500
350
350
50
2
1
1
1
12
1
20/60
20/60
20/60
10/60
15/60
40/60
333
167
167
117
1,050
33
50
300
300
7,400
7,400
7,400
7,400
1,730
615
615
450
400
100
36
1
12
30
24
12
50
5
1
40/60
10/60
35/60
125/60
5/60
27/60
10/60
75/60
10/60
10/60
36/60
13,333
5,000
6,300
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
7,821
1
10/60
1,304
........................
........................
........................
1,524,039
BSC, NCHS consists of up to 15 experts
including the Chair in fields associated
with the scientific and technical
program objectives of the Center.
DATES: Nominations for membership on
the BSC, NCHS will be accepted on a
rolling basis. To be considered for the
upcoming nomination slate,
submissions should be received no later
than September 22, 2023. Submissions
received after this time will not be
considered for the current membership
cycle.
ADDRESSES: All nominations should be
emailed to NCHS-BSCmail@cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Rebecca Hines, M.H.S., Designated
Federal Officer, Board of Scientific
Counselors, National Center for Health
Statistics, Centers for Disease Control
and Prevention, 3311 Toledo Road,
Mailstop P–08, Hyattsville, Maryland
20782. Telephone: (301) 458–4715;
Email: RSHines@cdc.gov.
SUPPLEMENTARY INFORMATION:
Nominations are sought for individuals
who have the expertise and
qualifications necessary to contribute to
the accomplishment of the objective of
the Board of Scientific Counselors,
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responses per
respondent
Sfmt 4703
National Center for Health Statistics
(BSC, NCHS) to provide advice and
guidance on statistical and
epidemiological research, data
collection, and activities that support
NCHS, such as: determinants of health;
extent and nature of illness and
disability, including life expectancy;
incidence of various acute and chronic
illnesses/impairments and accidental
injuries; prevalence of chronic diseases
and impairments; infant and maternal
morbidity and mortality; nutrition
status; environmental, social, and other
hazards affecting health status; health
resources associated with physician and
dental visits, hospitalizations, nursing,
extended care facilities, home health
agencies, and other health institutions;
utilization of health care in a broad
array of settings; trends in prices/costs
and sources of payments; federal, state,
and local government expenditures for
health care services; the relationship
between demographic and
socioeconomic characteristics and
health characteristics; family formation,
growth, and dissolution; new or
improved methods for obtaining current
data on the aforementioned factors; data
security and confidentiality and
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]]>Agencies
[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56827-56830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-0666; Docket No. CDC-2023-0068]
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). 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 October 20, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0068 by either of the following methods:
Federal eRulemaking Portal: ww.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;
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. 6/30/2026)--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
[[Page 56828]]
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)
collects data from healthcare facilities in the National Healthcare
Safety Network (NHSN) (OMB Control No. 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
seven 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 PS 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 HPS 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 BV
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 LTCF Component,
data is captured from skilled nursing facilities. Reporting methods
under the LTCF component have been created by using forms from the PS
Component as a model with modifications to specifically address the
specific characteristics of LTCF residents and the unique data needs of
these facilities reporting into NHSN. The Respiratory Tract Infection
Form (RTI)--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 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 National Nursing Home Quality Collaborative, which
focuses on recruiting nursing homes to report HAI data to NHSN and to
retain their continued participation.
The NHSN data collection was previously approved in June of 2023
for 6,209,922 responses and 1,693,215 annual burden hours. The proposed
changes in this Revision include modifications to 15 existing data
collection forms and one new form. CDC requests OMB approval for an
estimated annual burden 1,524,039 hours. There is no cost to
respondents other than their time to participate.
[[Page 56829]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form number & name Number of responses per per response Total burden
respondents respondent (min./hour) (hours)
----------------------------------------------------------------------------------------------------------------
57.100 NHSN Registration Form................... 2,000 1 5/60 167
57.101 Facility Contact Information............. 2,000 1 10/60 333
57.103 Patient Safety Component--Annual Hospital 5,311 1 135/60 11,950
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.... 6,387 12 15/60 19,161
57.108 Primary Bloodstream Infection (BSI)...... 5,775 5 38/60 18,288
57.111 Pneumonia (PNEU)......................... 1,800 2 30/60 1800
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)- 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 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 1 122/60 35,990
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 1,086 24 20/60 8,688
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 1,019 12 20/60 4,076
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.......... 1,099 12 15/60 3,297
57.142 Denominators for LTCF Locations.......... 714 12 35/60 4,998
57.143 Prevention Process Measures Monthly 357 12 5/60 357
Monitoring for LTCF............................
57.150 LTAC Annual Survey....................... 392 1 89/60 581
57.151 Rehab Annual Survey...................... 1,160 1 89/60 1,721
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.................
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..
[[Page 56830]]
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 350 1 10/60 117
Facility Survey................................
57.401 Outpatient Procedure Component--Monthly 350 12 15/60 1,050
Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day 50 1 40/60 33
Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly 50 400 40/60 13,333
Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI 300 100 10/60 5,000
Denominator....................................
57.405 Outpatient Procedure Component--Surgical 300 36 35/60 6,300
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............................
Healthcare-facility onset, antibiotic-treated 7,821 1 10/60 1,304
Clostridioides difficile (C. difficile)
Infection (HT-CDI) Event Module Annual
Reporting Plan.................................
---------------------------------------------------------------
Total Estimated Annual Burden Hours......... .............. .............. .............. 1,524,039
----------------------------------------------------------------------------------------------------------------
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. 2023-17924 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P
