CAUTI Events Among Patients With Spinal Cord Injury-Associated Neurogenic Bladder (SCI-NB); Request for Information: Reopening of Comment Period

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Disease Control and Prevention</SUBAGY> <DEPDOC>[Docket No. CDC-2025-0453]</DEPDOC> <SUBJECT>CAUTI Events Among Patients With Spinal Cord Injury-Associated Neurogenic Bladder (SCI-NB); Request for Information: Reopening of Comment Period</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Request for information (RFI). <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments must be received by February 2, 2026. Comments received after this date will not be considered. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Submit comments by either of the following methods: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov</E> . Follow the instructions for submitting comments. • <E T="03">Mail:</E> 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 <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov</E> . 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. <E T="03">Do not submit comments by email.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Henrietta Smith, RN, MSN, CIC, Lead-NHSN Protocol and Training Team, Surveillance Branch, Division of Healthcare Quality Promotion, by email at <E T="03">nhsn@cdc.gov</E> . 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> On September 8, 2025, CDC published a request for information in the <E T="04">Federal Register</E> (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. <SU>1</SU> 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. <E T="51">2 3</E> The outcomes of CAUTIs include discomfort to the patient, prolonged hospital stays, and other serious health complications, including death. <SU>4</SU> It has been estimated that each year, more than 13,000 deaths are associated with UTIs. <SU>5</SU> 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 ( <E T="03">https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf</E> ). The SCI-NB ICD-10-CM diagnosis codes are available on the NHSN UTI Events web page ( <E T="03">https://www.cdc.gov/nhsn/xls/SCI-NB_ICD-10-CM.xlsx</E> ). Additionally, the “Neurogenic Bladder” variable is accessible within the NHSN application ( <E T="03">https://sams.cdc.gov/</E> ). <NOTE> <HD SOURCE="HED">Note:</HD> 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. </NOTE> 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? <HD SOURCE="HD1">References</HD> <EXTRACT> <FP SOURCE="FP-2">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.</FP> <FP SOURCE="FP-2">2. McGuckin M. The patient survival guide: 8 simple solutions to prevent hospital and healthcare-associated infections. New York, NY: Demos Medical Publishing; 2012.</FP> <FP SOURCE="FP-2">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.</FP> <FP SOURCE="FP-2"> 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 Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, February 2009. </FP> <FP SOURCE="FP-2">5. Kelvins, R., Edward, J., et al. Estimating Healthcare-associated Infections and Deaths in U.S. Hospitals. Public Health Reports. 2007;122: 160-166.</FP> </EXTRACT> <SIG> <NAME>Noah Aleshire,</NAME> Chief Regulatory Officer, Centers for Disease Control and Prevention. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-23450 Filed 12-18-25; 8:45 am]</FRDOC> </NOTICE>