90 FR 136 pgs. 33952-33957 - Proposed Data Collection Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 90Number: 136Pages: 33952 - 33957
Pages: 33952, 33953, 33954, 33955, 33957Docket number: [60Day-25-0666; Docket No. CDC-2025-0091]
FR document: [FR Doc. 2025-13512 Filed 7-17-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0666; Docket No. CDC-2025-0091]
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 September 16, 2025.
ADDRESSES:
You may submit comments, identified by Docket No. CDC-2025-0091 by either of the following methods:
• Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking portal ( www.regulations.gov ) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT:
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-0666, Exp. 12/31/2027)-Revision-National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)
Background and Brief Description
[top] The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control 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 eight components: Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), Dialysis, Neonatal, and Medication Safety Component.
Data reported under the Patient Safety Component are used to determine the magnitude of the healthcare-associated adverse events and trends in the rates of the events, in the distribution of pathogens, and in the adherence to prevention practices. Data will help detect changes in the epidemiology of adverse events resulting from new medical therapies and changing patient risks. Additionally, reported data is being used to describe the epidemiology of antimicrobial use and resistance and to better understand the relationship of antimicrobial therapy to this rising problem.
Under the Healthcare Personnel Safety Component, protocols and data on events-both positive and adverse-are used to determine: (1) the magnitude of adverse events in healthcare personnel; and (2) compliance with immunization and sharps injuries safety guidelines.
Under the Biovigilance Component, data on adverse reactions and incidents associated with blood transfusions are reported and analyzed to provide national estimates of adverse reactions and incidents.
Under the Long-Term Care Facility Component, data is captured from skilled nursing facilities. Reporting methods under the LTCF component have been created by using forms from the PS Component as a model with modifications to specifically address the specific characteristics of LTCF residents and the unique data needs of these facilities reporting into NHSN. The Respiratory Tract Infection Form (RTI)-will not to be used by NHSN users, but as part of an EIP project with 4 EIP sites. The Form is titled Denominators for Healthcare Associated Infections (HAIs): Respiratory Tract Infections. The purpose of this form is to allow testing prior to introducing a new module and forms to NHSN users. The CDC's Epidemiology Research & Innovations Branch (ERIB) team will use the form to perform field testing of variables to explore the utilization, applicability, and data collection burden associated with these variables. This process will inform areas of improvement prior to incorporating the new module, including protocol, forms, and instructions into NHSN.
The Dialysis Component offers a simplified user interface for dialysis users to streamline their data entry and analysis processes as well as provide options for expanding in the future to include dialysis surveillance in settings other than outpatient facilities.
The Outpatient Procedure Component (OPC) gathers data on the impact of infections and outcomes related to operative procedures performed in Ambulatory Surgery Centers (ASCs). The OPC is used to monitor two event types: Same Day Outcome Measures and Surgical Site Infections (SSIs).
The Neonatal Component focuses on premature neonates and the healthcare associated events that occur because of their prematurity. This component currently has one module, which includes Late Onset-Sepsis and Meningitis.
The Medication Safety Component tracks medication safety and adverse drug events that are among the most common causes of iatrogenic harm in U.S. hospitals.
NHSN has increasingly served as the operating system for HAI reporting compliance through legislation established by the states. As of July 2023, 37 states, the District of Columbia and the City of Philadelphia, Pennsylvania have opted to use NHSN as their primary system for mandated reporting. Reporting compliance is completed by healthcare facilities in their respective jurisdictions, with emphasis on those states and municipalities acquiring varying consequences for failure to use NHSN. Additionally, healthcare facilities in five U.S. territories (Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and the Northern Mariana Islands) are voluntarily reporting to NHSN. Additional territories are projected to follow with similar use of NHSN for reporting purposes.
NHSN's data is used to aid in the tracking of HAIs and guide infection prevention activities/practices that protect patients. The Centers for Medicare and Medicaid Services (CMS) and other payers use these data to determine incentives for performance at healthcare facilities across the US 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.
[top] The ICR was previously approved in April 2025 for 4,508,255 burden hours. The proposed changes in this Revision include modifications to 67 existing data collection forms and the addition of three new forms. CDC requests OMB approval for an estimated 4,453,792 annual burden hours.
[top]
| Type of respondents | Form No. & name | Number of respondents | Number of responses per respondent | Average burden per response (hours) | Total burden (hours) |
|---|---|---|---|---|---|
| Infection Preventionist/Microbiologist | 57.100 NHSN Registration Form | 2,000 | 1 | 5/60 | 167 |
| Infection Preventionist/Microbiologist | 57.101 Facility Contact Information | 2,000 | 1 | 10/60 | 333 |
| Infection Preventionist/Microbiologist | 57.102 NHSN Help Desk Customer Satisfaction Survey | 26,400 | 1 | 2/60 | 880 |
| Infection Preventionist/Microbiologist | 57.103 Patient Safety Component-Annual Hospital Survey | 5,400 | 1 | 138/60 | 12420 |
| Infection Preventionist/Microbiologist | 57.104 NHSN Facility Administrator Change Request Form | 800 | 1 | 5/60 | 67 |
| Epidemiologists | 57.105 Group Contact Information | 1,000 | 1 | 5/60 | 83 |
| Infection Preventionist/Microbiologist | 57.106 Patient Safety Monthly Reporting Plan | 7,821 | 12 | 15/60 | 23463 |
| Infection Preventionist/Microbiologist | 57.108 Primary Bloodstream Infection (BSI) | 6,000 | 12 | 43/60 | 51600 |
| Infection Preventionist/Microbiologist | 57.111 Pneumonia (PNEU) | 1,800 | 2 | 33/60 | 1980 |
| Infection Preventionist/Microbiologist | 57.112 Ventilator-Associated Event (VAE) | 5,463 | 8 | 31/60 | 22580 |
| Infection Preventionist/Microbiologist | 57.113 Pediatric Ventilator-Associated Event (PedVAE) | 334 | 1 | 33/60 | 184 |
| Infection Preventionist/Microbiologist | 57.114 Urinary Tract Infection (UTI) | 6,000 | 12 | 25/60 | 30000 |
| Infection Preventionist/Microbiologist | 57.115 Custom Event | 600 | 91 | 38/60 | 34580 |
| Infection Preventionist/Microbiologist | 57.116 Denominators for Neonatal Intensive Care Unit (NICU) | 1,100 | 12 | 240/60 | 52800 |
| Infection Preventionist/Microbiologist | 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) | 500 | 12 | 300/60 | 30000 |
| Infection Preventionist/Microbiologist | 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) | 5,500 | 60 | 300/60 | 1650000 |
| Infection Preventionist/Microbiologist | 57.120 Surgical Site Infection (SSI) | 3,800 | 12 | 13/60 | 9880 |
| Infection Preventionist/Microbiologist | 57.121 Denominator for Procedure | 3,800 | 12 | 13/60 | 9880 |
| Epidemiologists | 57.122 HAI Progress Report State Health Department Survey | 55 | 1 | 50/60 | 46 |
| Pharmacist | 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables-Initial Set-up | 2,200 | 1 | 4800/60 | 176000 |
| Pharmacist | 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables-Yearly Maintenance | 3,300 | 2 | 120/60 | 13200 |
| Pharmacist | 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables-Monthly | 5,500 | 12 | 5/60 | 5500 |
| Pharmacist | 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables-Initial Set-up | 1,500 | 1 | 2400/60 | 60000 |
| Pharmacist | 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables-Yearly Maintenance | 4,000 | 1 | 120/60 | 8000 |
| Pharmacist | 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables-Monthly | 5,500 | 12 | 5/60 | 5500 |
| Infection Preventionist/Microbiologist | 57.126 MDRO or CDI Infection Form | 720 | 12 | 33/60 | 4752 |
| Infection Preventionist/Microbiologist | 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring | 5,500 | 29 | 15/60 | 39875 |
| Infection Preventionist/Microbiologist | 57.128 Laboratory-identified MDRO or CDI Event | 4,800 | 12 | 23/60 | 22080 |
| Infection Preventionist/Microbiologist | 57.129 Adult Sepsis | 50 | 12 | 28/60 | 280 |
| Infection Preventionist/Microbiologist | 57.130 Infectious Diseases of Public Health Concern | 3,650 | 365 | 35/60 | 777146 |
| Information Technology | 57.132 Patient Safety Component Digital Measure Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis, RPS, NVAP)-IT Initial Set up | 5,500 | 1 | 1620/60 | 148500 |
| Information Technology | 57.132 Patient Safety Component Digital Measure Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis, RPS, NVAP)-IT Yearly Maintenance | 5,500 | 1 | 1200/60 | 110000 |
| Infection Preventionist/Microbiologist | 57.132 Patient Safety Component Digital Measure Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis, RPS, NVAP)-Infection Preventionist | 5,500 | 4 | 10/60 | 3667 |
| Infection Preventionist/Microbiologist | 57.132 Patient Safety Digital Reporting Plan (RPS CSV) | 5,500 | 365 | 2/60 | 66917 |
| Infection Preventionist/Microbiologist | 57.133 Patient Safety Attestation | 3,500 | 1 | 10/60 | 583 |
| Infection Preventionist/Microbiologist | 57.137 Long-Term Care Facility Component-Annual Facility Survey | 6,270 | 1 | 135/60 | 14108 |
| Infection Preventionist/Microbiologist | 57.138 Laboratory-identified MDRO or CDI Event for LTCF | 286 | 24 | 22/60 | 2517 |
| Infection Preventionist/Microbiologist | 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF | 738 | 12 | 10/60 | 1476 |
| Infection Preventionist/Microbiologist | 57.140 Urinary Tract Infection (UTI) for LTCF | 373 | 24 | 37/60 | 5520 |
| Infection Preventionist/Microbiologist | 57.141 Monthly Reporting Plan for LTCF | 546 | 12 | 5/60 | 546 |
| Infection Preventionist/Microbiologist | 57.142 Denominators for LTCF Locations | 724 | 12 | 35/60 | 5068 |
| Infection Preventionist/Microbiologist | 57.143 Prevention Process Measures Monthly Monitoring for LTCF | 434 | 12 | 5/60 | 434 |
| Infection Preventionist/Microbiologist | 57.145 Long Term Care Antimicrobial Use (LTC-AU) Module-Digital Upload Specification Tables | 16,500 | 12 | 5/60 | 16500 |
| Infection Preventionist/Microbiologist | 57.150 LTAC Annual Survey | 395 | 1 | 100/60 | 658 |
| Infection Preventionist/Microbiologist | 57.151 Rehab Annual Survey | 395 | 1 | 84/60 | 553 |
| Occupational Health RN/Specialist | 57.211 Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities-Manual | 117 | 12 | 25/60 | 585 |
| Occupational Health RN/Specialist | 57.211 Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities-.CSV | 3,080 | 12 | 20/60 | 12320 |
| Occupational Health RN/Specialist | 57.214 Annual Healthcare Personnel Influenza Vaccination Summary-Manual | 22,440 | 1 | 120/60 | 44880 |
| Occupational Health RN/Specialist | 57.214 Annual Healthcare Personnel Influenza Vaccination Summary-.CSV | 1,920 | 1 | 55/60 | 1760 |
| Occupational Health RN/Specialist | 57.215 Seasonal Survey on Influenza Vaccination Programs for Healthcare Personnel | 15,426 | 1 | 45/60 | 11570 |
| Medical/Clinical Laboratory Technologist | 57.300 Hemovigilance Module Annual Survey | 57 | 1 | 30/60 | 29 |
| Medical/Clinical Laboratory Technologist | 57.301 Adverse Reaction Investigaton Form | 47 | 5 | 20/60 | 78 |
| Medical/Clinical Laboratory Technologist | 57.302 Transfusion Transmitted Infections (TTI) Rapid Alert Form | 3 | 1 | 5/60 | 1 |
| Medical/Clinical Laboratory Technologist | 57.303 Transfusion Transmitted Infections (TTI) Investigation Form | 3 | 1 | 60/60 | 3 |
| Infection Preventionist/Microbiologist | 57.400 Outpatient Procedure Component-Annual Ambulatory Surgery Center Survey | 350 | 1 | 10/60 | 58 |
| Infection Preventionist/Microbiologist | 57.401 Outpatient Procedure Component-Monthly Reporting Plan | 350 | 12 | 10/60 | 700 |
| Infection Preventionist/Microbiologist | 57.402 Outpatient Procedure Component Same Day Outcome Measures | 50 | 1 | 42/60 | 35 |
| Infection Preventionist/Microbiologist | 57.403 Outpatient Procedure Component-Denominators for Same Day Outcome Measures | 50 | 400 | 20/60 | 6667 |
| Infection Preventionist/Microbiologist | 57.404 Outpatient Procedure Component-SSI Denominator | 300 | 100 | 22/60 | 11000 |
| Infection Preventionist/Microbiologist | 57.405 Outpatient Procedure Component-Surgical Site (SSI) Event | 300 | 36 | 39/60 | 7020 |
| Infection Preventionist/Microbiologist | 57.408 Monthly Survey Patient Days & Nurse Staffing | 2,500 | 12 | 300/60 | 150000 |
| Infection Preventionist/Microbiologist | 57.500 Outpatient Dialysis Center Practices Survey | 6,900 | 1 | 149/60 | 17135 |
| Infection Preventionist/Microbiologist | 57.501 Dialysis Monthly Reporting Plan | 7,400 | 12 | 5/60 | 7400 |
| Infection Preventionist/Microbiologist | 57.502 Dialysis Event | 7,400 | 30 | 49/60 | 181300 |
| Infection Preventionist/Microbiologist | 57.503 Denominator for Outpatient Dialysis | 7,400 | 12 | 10/60 | 14800 |
| Infection Preventionist/Microbiologist | 57.504 Prevention Process Measures Monthly Monitoring for Dialysis | 1,730 | 12 | 60/60 | 20760 |
| Infection Preventionist/Microbiologist | 57.507 Home Dialysis Center Practices Survey | 550 | 1 | 65/60 | 596 |
| Information Technology | 57.600 Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Initial Set up | 5,500 | 1 | 1620/60 | 148500 |
| Information Technology | 57.600 Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Yearly Maintenance | 5,500 | 1 | 1200/60 | 110000 |
| Infection Preventionist/Microbiologist | 57.600 Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-Infection Preventionist | 5,500 | 6 | 6/60 | 3300 |
| Infection Preventionist/Microbiologist | 57.600 Neonatal Component Late Onset Sepsis Meningitis (LOSMEN) Module CDA Data Collection-Infection Preventionist | 5,500 | 12 | 2/60 | 2200 |
| Infection Preventionist/Microbiologist | 57.601 Late Onset Sepsis/Meningitis Denominator Form: Late Onset Sepsis/Meningitis Denominator Form: Data Table for monthly electronic upload | 300 | 6 | 5/60 | 150 |
| Infection Preventionist/Microbiologist | 57.602 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly Electronic Upload | 300 | 6 | 5/60 | 150 |
| Information Technology | 57.700 Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE)-IT Initial Set up | 5,500 | 1 | 1620/60 | 148500 |
| Information Technology | 57.700 Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE)-IT Yearly Maintenance | 5,500 | 1 | 1200/60 | 110000 |
| Infection Preventionist/Microbiologist | 57.700 Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE)-Infection Preventionist | 5,500 | 4 | 10/60 | 3667 |
| Infection Preventionist/Microbiologist | 57.701 Medication Safety Component-Annual Hospital Survey | 10 | 1 | 180/60 | 30 |
| Registered Nurse | 57.800 Billing Code Data: 837I Upload | 5,500 | 4 | 5/60 | 1833 |
| Epidemiologist | 57.801 External Validation Summary Report | 20 | 2 | 15/60 | 10 |
| Information Technology | 57.802 Bed Capacity-IT Initial Set Up | 25 | 1 | 20/60 | 8 |
| Information Technology | 57.803 All Hazards | 540 | 365 | 5/60 | 16425 |
[top]
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2025-13512 Filed 7-17-25; 8:45 am]
BILLING CODE 4163-18-P