60-day Federal Register Notice

B. Published 60-Day Federal Register.pdf

[NCEZID] The National Healthcare Safety Network (NHSN)

60-day Federal Register Notice

OMB: 0920-0666

Document [pdf]
Download: pdf | pdf
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:

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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

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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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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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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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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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Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
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:

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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 [email protected].
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: [email protected].
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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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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