Notice2025-23450
CAUTI Events Among Patients With Spinal Cord Injury-Associated Neurogenic Bladder (SCI-NB); Request for Information: Reopening of Comment Period
Primary source
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Published
December 19, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), is reopening the public comment period for a request for information (RFI) that was initially published on September 8, 2025, regarding Catheter-associated Urinary Tract Infections (CAUTIs) among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI- NB). We want to understand better the burden of CAUTIs among this patient population and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This docket provides an opportunity for professionals who work with this patient population, as well as those who conduct NHSN UTI surveillance, to offer feedback related to our approach.
Full Text
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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Pages 59522-59524]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23450]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2025-0453]
CAUTI Events Among Patients With Spinal Cord Injury-Associated
Neurogenic Bladder (SCI-NB); Request for Information: Reopening of
Comment Period
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Request for information (RFI).
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SUMMARY: The Centers for Disease Control and Prevention (CDC), in the
Department of Health and Human Services (HHS), is reopening the public
comment period for a request for
[[Page 59523]]
information (RFI) that was initially published on September 8, 2025,
regarding Catheter-associated Urinary Tract Infections (CAUTIs) among
patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI-
NB). We want to understand better the burden of CAUTIs among this
patient population and any implications related to reporting within the
CDC National Healthcare Safety Network (NHSN) device-associated urinary
tract infection (UTI) event module. This docket provides an opportunity
for professionals who work with this patient population, as well as
those who conduct NHSN UTI surveillance, to offer feedback related to
our approach.
DATES: Comments must be received by February 2, 2026. Comments received
after this date will not be considered.
ADDRESSES: Submit comments by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: Comments may also be sent by mail to the attention
of Henrietta Smith, Division of Healthcare Quality Promotion, National
Center for Emerging and Zoonotic Infectious Diseases, CDC, 1600 Clifton
Rd. NE, Mail Stop H16-3, Atlanta 30333
Instructions: All written submissions received in response to this
document must include the agency name and docket number (CDC-2025-0453)
for this activity. Please note that comments received, including
attachments and other supporting materials, are part of the public
record and are subject to public disclosure. Comments will be posted on
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Therefore, do not include any information
in your comment or supporting materials that you consider confidential
or inappropriate for public disclosure. CDC will review all submissions
and may choose to redact, or withhold, submissions containing private
or proprietary information such as Social Security numbers, medical
information, inappropriate language, or duplicate submissions. Do not
submit comments by email.
FOR FURTHER INFORMATION CONTACT: Henrietta Smith, RN, MSN, CIC, Lead-
NHSN Protocol and Training Team, Surveillance Branch, Division of
Healthcare Quality Promotion, by email at <a href="/cdn-cgi/l/email-protection#1a747269745a797e79347d756c"><span class="__cf_email__" data-cfemail="a8c6c0dbc6e8cbcccb86cfc7de">[email protected]</span></a>. Please include
the docket number (CDC-2025-0453) and ``CAUTI events among patients
with Spinal Cord Injury-associated Neurogenic Bladder (SCI-NB)'' in the
subject line.
SUPPLEMENTARY INFORMATION: On September 8, 2025, CDC published a
request for information in the Federal Register (90 FR 43187). The
initial comment period closed on December 8, 2025. To allow interested
parties additional time to submit comments, CDC is reopening the
comment period for 45 days. CDC is committed to protecting patients and
healthcare workers from adverse healthcare events and promoting safety,
quality, and value in healthcare delivery. Preventing healthcare-
associated infections (HAIs) is a priority for CDC and its partners in
public health and healthcare. As part of this work, CDC supports
surveillance of Catheter-associated Urinary Tract Infections (CAUTIs)
and Non-Catheter-associated Urinary Tract Infections (UTIs) and other
Urinary System Infections (USIs).
UTIs are the fifth most common type of HAI, with an estimated
62,700 UTIs in acute care hospitals in 2015. UTIs account for more than
9.5% of infections reported by acute care hospitals.\1\ Virtually all
healthcare-associated UTIs are associated with instrumentation of the
urinary tract.
Approximately 12-16% of adult hospital inpatients will have an
indwelling urinary catheter (IUC) at some time during their
hospitalization, and each day the IUC remains, a patient has a 3-7%
increased risk of acquiring a CAUTI.<SUP>2 3</SUP> The outcomes of
CAUTIs include discomfort to the patient, prolonged hospital stays, and
other serious health complications, including death.\4\ It has been
estimated that each year, more than 13,000 deaths are associated with
UTIs.\5\
Historically, the National Healthcare Safety Network has not
collected data that specifically identify which patients with CAUTI
events have Spinal Cord Injury-associated Neurogenic Bladder (SCI-NB).
To enhance CDC's understanding of the burden of CAUTIs in this patient
population, a ``Neurogenic Bladder'' risk factor variable has been
added within the NHSN application. This variable allows NHSN users to
indicate whether a CAUTI event occurred in patients with SCI-NB by
using specific ICD-10-CM diagnosis codes. This new variable is
currently optional.
NHSN's current definition of SCI-NB is in Chapter 7-UTI Events of
the Patient Safety Component (PSC) manual (<a href="https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf">https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf</a>). The SCI-NB ICD-10-CM diagnosis
codes are available on the NHSN UTI Events web page (<a href="https://www.cdc.gov/nhsn/xls/SCI-NB_ICD-10-CM.xlsx">https://www.cdc.gov/nhsn/xls/SCI-NB_ICD-10-CM.xlsx</a>). Additionally, the
``Neurogenic Bladder'' variable is accessible within the NHSN
application (<a href="https://sams.cdc.gov/">https://sams.cdc.gov/</a>).
Note: The ``Neurogenic Bladder'' variable will be required
starting January 2026. NHSN's definition of SCI-NB will be expanded
to include both traumatic and non-traumatic etiologies of spinal
cord injuries also starting January 2026.
This docket provides an opportunity for professionals who work with
the SCI-NB patient population, as well as those who conduct NHSN UTI
surveillance, to share their perspectives and concerns, which will help
inform our decisions on the ``Neurogenic Bladder'' variable in the
future. The CDC is also seeking additional insights into the unintended
consequences of including the SCI-NB patient population in UTI
surveillance, and public comments will help guide our approach moving
forward. Specifically, CDC is interested in receiving information
related to the following:
1. What challenges or barriers might the required reporting of
spinal cord injury-associated neurogenic bladder ICD-10-CM diagnosis
codes within the NHSN application pose for your facility? How could
these challenges or barriers be minimized?
2. Would your facility be able to report the necessary procedure
code data within 4.5 months of the end of the quarter in which the
procedure occurred? If not, why not, and what is the shortest amount of
time following the end of the quarter that the complete data would be
available?
3. At your facility, of the patients with spinal cord injury, what
injury type or condition (ICD-10-CM diagnosis codes can be provided) is
most strongly associated with CAUTIs?
4. At your facility, have patients with spinal cord injury-
associated neurogenic bladder experienced harms, complications, or any
other unintended consequences from efforts to monitor and prevent
CAUTIs?
References
1. Magill S., O'Leary S. Janelle D., et al. Changes in Prevalence of
Health Care Associated Infection in the U.S. Hospitals. New England
Journal of Medicine. 2018;379: 1732-1744.
2. McGuckin M. The patient survival guide: 8 simple solutions to
prevent hospital and healthcare-associated infections. New York, NY:
Demos Medical Publishing; 2012.
3. Lo E, Nicolle LE, Coffin SE, Gould C, Maragakis LL, Madding's J,
et al. Strategies to prevent catheter-associated urinary tract
infections in acute care hospitals: 2014 update. Infection Control
and Hospital Epidemiology 2014; 35:464-79.
4. Scott R. The Direct Medical Costs of Healthcare-Associated
Infections in U.S. Hospitals and the Benefits of Prevention, 2009.
Division of Healthcare Quality
[[Page 59524]]
Promotion, National Center for Preparedness, Detection, and Control
of Infectious Diseases, Coordinating Center for Infectious Diseases,
Centers for Disease Control and Prevention, February 2009.
5. Kelvins, R., Edward, J., et al. Estimating Healthcare-associated
Infections and Deaths in U.S. Hospitals. Public Health Reports.
2007;122: 160-166.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2025-23450 Filed 12-18-25; 8:45 am]
BILLING CODE 4163-18-P
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