[NCEZID] The National Healthcare Safety Network (NHSN)

Forms and Documents

Document Name	Status
Form 57.106 57.106 Patient Safety Monthly Reporting Plan Form and Instruction	Unchanged
Form 57.803 All Hazards Form and Instruction	Unchanged
Form 57.802 Bed Capacity-IT Initial Set Up Form and Instruction	Unchanged
Form 57.801 External Validation Summary Report Form and Instruction	Unchanged
Form 57.215 Seasonal Survey on Influenza Vaccination Programs for Healthcare Personnel Form and Instruction	Unchanged
Form 57.214 Annual Healthcare Personnel Influenza Vaccination Summary (CSV) Form	Unchanged
Form 57.211 Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities (CSV) Form	Unchanged
Form 57.133 Patient Safety Attestation Form and Instruction	Unchanged
Form 57.130 Pathogens of High Consequence Form and Instruction	Modified
Form 57.124 AUR Pharmacy Data Electronic Upload Specification Tables (Yearly Maintenance) Form	Unchanged
Form 57.124 AUR Pharmacy Data Electronic Upload Specification Tables (Initial Set-up) Form	Unchanged
Form 57.123 AUR Microbiolgy Data Electronic Upload Specification Tables (Yearly Maintenance) Form	Unchanged
Form 57.123 AUR Microbiology Data Electronic Upload Specification Tables (Initial Set-up) Form	Unchanged
Form 57.102 NHSN Help Desk Customer Satisfaction Survey Form and Instruction	Unchanged
Form CDC 57.302 Hemovigilance Module Monthly Incident Summary Form and Instruction	Unchanged
Form 57.800 Billing Code Data: 837I Upload Form	Unchanged
Form 57.701 57.701 - Glycemic Control Module-HYPO Annual Survey Form and Instruction	Unchanged
Form 57.700 57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-Infection Preventionist Form and Instruction	Unchanged
Form 57.700 57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Yearly Maintenance Form and Instruction	Unchanged
Form 57.700 57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Initial Set up Form and Instruction	Unchanged
Form 57.600 57.600 - Neonatal Component Late Onset Sepsis Meningitis (LOSMEN) Module CDA Data Collection-Infection Preventionist Form and Instruction	Unchanged
Form 57.600 57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-Infection Preventionist Form and Instruction	Unchanged
Form 57.600 57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Yearly Maintenance Form and Instruction	Unchanged
Form 57.600 57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Initial Set up Form and Instruction	Unchanged
Form 57.145 57.145 - Long Term Care Antimicrobial Use (LTC-AU) Module CDA Form and Instruction	Unchanged
Form 57.132 57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-Infection Preventionist Form and Instruction	Unchanged
Form 57.132 57.132 - Patient Safety Digital Reporting Plan (RPS CSV) Form and Instruction	Unchanged
Form 57.408 Monthly Survey Patient Days & Nurse Staffing Form and Instruction	Unchanged
Form CDC 57.214 Annual Healthcare Personnel Influenza Vaccination Summary (manual) Form and Instruction	Unchanged
Form CDC 57.211 Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities Form and Instruction	Unchanged
Form 57.601 Late Onset Sepsis/Meningitis Denominator Form: Data Table (Monthly) Form and Instruction	Unchanged
Form 57.602 Long Term Care Facility Component - Respiratory Tract Infection Form and Instruction	Unchanged
57.104 NHSN Administrator Change Request Form Form and Instruction	Unchanged
Form CDC 55.122 57.122 HAI Progress Report State Health Department Survey Form	Unchanged
Form CDC 57.405 57.405 Outpatient Procedure Component - Surgical Site Infection (SSI) Event Form	Unchanged
Form 57.404 57.404 Outpatient Procedure Component - SSI Denominators Form	Unchanged
Form 57.507 57.507 Home Dialysis Center Practices Survey Form	Unchanged
Form 57.320 57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction Form	Unchanged
Form CDC 57.319 57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction Form	Unchanged
Form CDC 57.318 57.318 Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload Form	Unchanged
Form 57.317 57.317 Hemovigilance Adverse Reaction - Transfusion Associated Acute Lung Injury Form	Unchanged
Form CDC 57.316 57.316 Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease Form	Unchanged
Form CDC 57.315 57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea Form	Unchanged
Form 57.314 57.314 Hemovigilance Adverse Reaction - Post Transfusion Purpura Form	Unchanged
Form 57.313 57.313 Hemovigilance Adverse Reaction - Infection Form	Unchanged
Form 57.312 57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction Form	Unchanged
Form CDC 57.311 57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction Form	Unchanged
Form 57.310 57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction Form	Unchanged
Form CDC 57.309 57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction Form	Unchanged
Form 57.308 57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction Form	Unchanged
Form 57.307 57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction Form	Unchanged
Form 57.306 57.306 Hemovigilance Module Annual Facility Survey - Non-acute Care Facility Form	Unchanged
Form 57.129 57.129_Adult Sepsis Form	Unchanged
Form CDC 57.115 57.115 Custom Event Form	Unchanged
Form 57.113 57.113 Pediatric Ventilator-Associated Event (PedVAE) Form and Instruction	Unchanged
Form CDC 57.504 57.504 Prevention Process Measures Monthly Monitoring for Dialysis Form	Unchanged
Form CDC 57.501 57.501 Dialysis Monthly Reporting Plan Form	Unchanged
Form CDC 57.403 57.403 Outpatient Procedure Component - Monthly Denominators and Summary Form	Unchanged
Form CDC 57.402 57.402 Outpatient Procedure Component Event Form	Unchanged
Form CDC 57.401 57.401 Outpatient Procedure - Monthly Reporting Plan Form	Unchanged
Form CDC 57.400 57.400 Outpatient Procedure - Annual Facility Survey Form	Unchanged
Form 57.151 57.151 Patient Safety Component -- Annual Facility Survey for IRF Form and Instruction	Unchanged
Form 57.150 57.150 Patient Safety Component -- Annual Facility Survey for LTAC Form and Instruction	Unchanged
Form CDC 57.143 57.143 Prevention Process Measures Monthly Monitoring for LTCF Form	Unchanged
Form CDC 57.142 57.142 Denominators for LTCF Locations Form	Unchanged
Form CDC 57.141 57.141 Monthly Reporting Plan for LTCF Form	Unchanged
Form 57.112 57.112 Ventilator-Associated Event (VAE) Form and Instruction	Unchanged
Form CDC 57.139 57.139 MDRO and CDI Prevention Process Measures Monthly for LTCF Form	Unchanged
Form CDC 57.138 57.138 Laboratory-Identified MDRO or CDI Event for LTCF Form	Unchanged
Form CDC 57.137 57.137 Long Term care Facility Component--Annual Facility Survey Form	Unchanged
Form CDC 57.305 57.305 Hemovigilance Incident Form	Unchanged
Form CDC 57.303 57.303 Hemovigilance Module Monthly Reporting Denominators Form and Instruction	Unchanged
Form 57.301 57.301 Hemovigilance Module Monthly Reporting Plan Form and Instruction	Unchanged
Form CDC 57.300 57.300 Hemovigilance Module Annual Survey -- Acute Care Facility Form	Unchanged
Form CDC 57.105 57.105 Group Contact Information Form	Unchanged
Form 57.140 57.140 Urinary Tract Infection (UTI) for LTCF Form and Instruction	Unchanged
Form 57.103 57.103 Patient Safety Component - Annual Hospital Survey Form and Instruction	Unchanged
Form CDC 57.101 57.101 Facility Contact Information Form	Unchanged
Form 57.124 57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data Form and Instruction	Unchanged
Form 57.123 57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables Form and Instruction	Unchanged
Form CDC 57.100 57.100 NHSN Registration Form Form	Unchanged
Form 57.121 57.121 Denominators for Procedure Form and Instruction	Unchanged
Form 57.128 57.128 Laboratory Identified or CDI MDRO Event Form	Unchanged
Form CDC 57.120 57.120 Surgical Site Infection (SSI) Form	Unchanged
Form CDC 57.126 57.126 MDRO or CDI Infection Event Form	Unchanged
Form CDC 57.503 57.503 Denominators for Outpatient Dialysis Form	Unchanged
Form CDC 57.127 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Form	Unchanged
Form CDC 57.118 57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA) Form	Unchanged
Form CDC 57.117 57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC) Form	Unchanged
Form CDC 57.125 57.125 Central Line Insertion Practices Adherence Monitoring Form Form	Unchanged
Form CDC 57.116 57.116 Denominators for Neonatal Intensive Care Unit (NICU) Form	Unchanged
Form 57.114 57.114 Urinary Tract Infection (UTI) Form and Instruction	Unchanged
Form 57.111 57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) Form and Instruction	Unchanged
Form CDC 57.502 57.502 Dialysis Event Form and Instruction	Unchanged
Form 57.108 57.108 Primary Bloodstream Infection (BSI) Form and Instruction	Unchanged
Form 57.500 57.500 Outpatient Dialysis Center Practices Survey Form and Instruction	Unchanged
Emergency Request Memo_NHSN_OIRA 12.20.24 dbj.docx Supplementary Document	2024-12-20
G3. Privacy Impact Assessment_NHSN_PIA_Signed_2023-01-19.pdf Supplementary Document	2024-12-20
Human Subject Determination-IRB approval.pdf Supplementary Document	2024-12-20
2025 OMB FHIR RPS Data Dictionary_Updated_8_23_2024.xlsx Supplementary Document	2024-10-31
2025 OMB FHIR ACH Monthly Measures Data Dictionary_8_23_2024.xlsx Supplementary Document	2024-10-31
G3. Privacy Impact Assessment_NHSN_PIA_Signed_2023-01-19.pdf Supplementary Document	2024-10-31
G2. Privacy Impact Assessment_ NHSN2-Cloud_PIA_Signed_2023-12-05_eRAP.pdf Supplementary Document	2024-10-31
G1. Privacy Impact Assessment.pdf Supplementary Document	2024-10-31
F2. NHSN 308d Request for Extension and Ammendment.docx Supplementary Document	2024-10-31
F1. NHSN 308d Approval 2015.pdf Supplementary Document	2024-10-31
E3. Human Subjects Determination_2.pdf Supplementary Document	2024-10-31
E2. Report of End of Human Research Review 0.1253.docx Supplementary Document	2024-10-31
E1. Closure CDC Protocol # 4062.docx Supplementary Document	2024-10-31
D2. Explanation for Program Changes or Adjustments 2024-0920-0666.docx Supplementary Document	2024-10-31
D1. Explanation for Program Changes or Adjustments 2024-0920-0666_v2.docx Supplementary Document	2024-10-31
B. 60-Day Published Federal Register Notice.pdf Supplementary Document	2024-10-30
A3. 42 USC 242m.pdf Supplementary Document	2024-10-30
A2. 42 USC 242k.pdf Supplementary Document	2024-10-30
A1. 42 USC 242b.pdf Supplementary Document	2024-10-30
Supporting Statement B.docx Supporting Statement B	2024-12-20
Supporting Statement A.docx Supporting Statement A	2024-12-20

IC Document Collections

IC ID	Document Title	Status
7134	57.106 Patient Safety Monthly Reporting Plan Form and Instruction	Unchanged
272124	All Hazards Form and Instruction	Unchanged
272123	Bed Capacity-IT Initial Set Up Form and Instruction	Unchanged
272122	External Validation Summary Report Form and Instruction	Unchanged
272108	Seasonal Survey on Influenza Vaccination Programs for Healthcare Personnel Form and Instruction	Unchanged
272105	Annual Healthcare Personnel Influenza Vaccination Summary (CSV) Form	Unchanged
272101	Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities (CSV) Form	Unchanged
272031	Patient Safety Attestation Form and Instruction	Unchanged
272029	Pathogens of High Consequence Form and Instruction	Modified
272027	AUR Pharmacy Data Electronic Upload Specification Tables (Yearly Maintenance) Form	Unchanged
272026	AUR Pharmacy Data Electronic Upload Specification Tables (Initial Set-up) Form	Unchanged
272025	AUR Microbiolgy Data Electronic Upload Specification Tables (Yearly Maintenance) Form	Unchanged
272024	AUR Microbiology Data Electronic Upload Specification Tables (Initial Set-up) Form	Unchanged
272017	NHSN Help Desk Customer Satisfaction Survey Form and Instruction	Unchanged
265665	Hemovigilance Module Monthly Incident Summary Form and Instruction	Unchanged
263469	Billing Code Data: 837I Upload Form	Unchanged
263468	57.701 - Glycemic Control Module-HYPO Annual Survey Form and Instruction	Unchanged
263467	57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-Infection Preventionist Form and Instruction	Unchanged
263466	57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Yearly Maintenance Form and Instruction	Unchanged
263465	57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Initial Set up Form and Instruction	Unchanged
263464	57.600 - Neonatal Component Late Onset Sepsis Meningitis (LOSMEN) Module CDA Data Collection-Infection Preventionist Form and Instruction	Unchanged
263463	57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-Infection Preventionist Form and Instruction	Unchanged
263462	57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Yearly Maintenance Form and Instruction	Unchanged
263461	57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Initial Set up Form and Instruction	Unchanged
263460	57.145 - Long Term Care Antimicrobial Use (LTC-AU) Module CDA Form and Instruction	Unchanged
263453	57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-Infection Preventionist Form and Instruction	Unchanged
263452	57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-IT Yearly Maintenance Other-OMB Header and Burden Statement	Unchanged
263450	57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-IT Initial Set up Other-OMB Header and Burden Statement	Unchanged
263449	57.132 - Patient Safety Digital Reporting Plan (RPS CSV) Form and Instruction	Unchanged
257463	Monthly Survey Patient Days & Nurse Staffing Form and Instruction	Unchanged
246758	Annual Healthcare Personnel Influenza Vaccination Summary (manual) Form and Instruction	Unchanged
246755	Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities Form and Instruction	Unchanged
244476	Late Onset Sepsis/Meningitis Denominator Form: Data Table (Monthly) Form and Instruction	Unchanged
238093	Long Term Care Facility Component - Respiratory Tract Infection Form and Instruction	Unchanged
237430	57.104 NHSN Administrator Change Request Form Form and Instruction	Unchanged
233214	57.122 HAI Progress Report State Health Department Survey Form	Unchanged
228154	57.405 Outpatient Procedure Component - Surgical Site Infection (SSI) Event Form	Unchanged
228153	57.404 Outpatient Procedure Component - SSI Denominators Form	Unchanged
222908	57.507 Home Dialysis Center Practices Survey Form	Unchanged
222907	57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction Form	Unchanged
222906	57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction Form	Unchanged
222905	57.318 Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload Form	Unchanged
222904	57.317 Hemovigilance Adverse Reaction - Transfusion Associated Acute Lung Injury Form	Unchanged
222903	57.316 Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease Form	Unchanged
222902	57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea Form	Unchanged
222901	57.314 Hemovigilance Adverse Reaction - Post Transfusion Purpura Form	Unchanged
222900	57.313 Hemovigilance Adverse Reaction - Infection Form	Unchanged
222899	57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction Form	Unchanged
222898	57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction Form	Unchanged
222897	57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction Form	Unchanged
222896	57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction Form	Unchanged
222895	57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction Form	Unchanged
222894	57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction Form	Unchanged
222893	57.306 Hemovigilance Module Annual Facility Survey - Non-acute Care Facility Form	Unchanged
222892	57.129_Adult Sepsis Form	Unchanged
222891	57.115 Custom Event Form	Unchanged
222890	57.113 Pediatric Ventilator-Associated Event (PedVAE) Form and Instruction	Unchanged
208409	57.504 Prevention Process Measures Monthly Monitoring for Dialysis Form	Unchanged
208408	57.501 Dialysis Monthly Reporting Plan Form	Unchanged
208407	57.403 Outpatient Procedure Component - Monthly Denominators and Summary Form	Unchanged
208406	57.402 Outpatient Procedure Component Event Form	Unchanged
208405	57.401 Outpatient Procedure - Monthly Reporting Plan Form	Unchanged
208404	57.400 Outpatient Procedure - Annual Facility Survey Form	Unchanged
200382	57.151 Patient Safety Component -- Annual Facility Survey for IRF Form and Instruction	Unchanged
200381	57.150 Patient Safety Component -- Annual Facility Survey for LTAC Form and Instruction	Unchanged
200380	57.143 Prevention Process Measures Monthly Monitoring for LTCF Form	Unchanged
200379	57.142 Denominators for LTCF Locations Form	Unchanged
200378	57.141 Monthly Reporting Plan for LTCF Form	Unchanged
200377	57.112 Ventilator-Associated Event (VAE) Form and Instruction	Unchanged
197543	57.139 MDRO and CDI Prevention Process Measures Monthly for LTCF Form	Unchanged
197542	57.138 Laboratory-Identified MDRO or CDI Event for LTCF Form	Unchanged
197541	57.137 Long Term care Facility Component--Annual Facility Survey Form	Unchanged
190364	57.305 Hemovigilance Incident Form	Unchanged
190363	57.303 Hemovigilance Module Monthly Reporting Denominators Form and Instruction	Unchanged
190361	57.301 Hemovigilance Module Monthly Reporting Plan Form and Instruction	Unchanged
190360	57.300 Hemovigilance Module Annual Survey -- Acute Care Facility Form	Unchanged
183576	57.105 Group Contact Information Form	Unchanged
183573	57.140 Urinary Tract Infection (UTI) for LTCF Form and Instruction	Unchanged
183572	57.103 Patient Safety Component - Annual Hospital Survey Form and Instruction	Unchanged
183570	57.101 Facility Contact Information Form	Unchanged
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data Form and Instruction	Unchanged
183566	57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables Form and Instruction	Unchanged
183565	57.100 NHSN Registration Form Form	Unchanged
183564	57.121 Denominators for Procedure Form and Instruction	Unchanged
183563	57.128 Laboratory Identified or CDI MDRO Event Form	Unchanged
183562	57.120 Surgical Site Infection (SSI) Form	Unchanged
183561	57.126 MDRO or CDI Infection Event Form	Unchanged
183560	57.503 Denominators for Outpatient Dialysis Form	Unchanged
183559	57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Form	Unchanged
183558	57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA) Form	Unchanged
183556	57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC) Form	Unchanged
183555	57.125 Central Line Insertion Practices Adherence Monitoring Form Form	Unchanged
183554	57.116 Denominators for Neonatal Intensive Care Unit (NICU) Form	Unchanged
183551	57.114 Urinary Tract Infection (UTI) Form and Instruction	Unchanged
183549	57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) Form and Instruction	Unchanged
183547	57.502 Dialysis Event Form and Instruction	Unchanged
183545	57.108 Primary Bloodstream Infection (BSI) Form and Instruction	Unchanged
183544	57.500 Outpatient Dialysis Center Practices Survey Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 202412-0920-018
Status: Received in OIRA	Previous ICR Reference No: 202410-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0666
Title: [NCEZID] The National Healthcare Safety Network (NHSN)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 12/31/2024
Date Submitted to OIRA: 12/20/2024

	Requested	Previously Approved
Expiration Date	6 Months From Approved	12/31/2027
Responses	5,896,361	5,896,361
Time Burden (Hours)	4,508,255	4,397,234
Cost Burden (Dollars)	0	0

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Abstract: The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. This Emergency Revision Request is submitted to add three (3) additional diseases to the data collection, Influenza A (H5), Marburg, and Oropouche. Data will be collected following modification of the previously approved Form 57.130 - Pathogens of High Consequence. An additional 111,021 burden hours will be added to the collection.

Emergency Justfication: Emergency Processing is requested to add four (4) additional pathogens of concern to the NHSN (OMB Control No. 0910-0666) data collection: Influenza A (H5), Marburg, and Oropouche. This requested update in disease surveillance will illustrate which patient populations are being affected by these pathogens and the potential need for additional healthcare infection prevention and control. Since this form is collecting data on hospitalized patients, the update will also help inform on the severity of illness a high consequence pathogen is causing as well as what region(s) of the country are affected. Data collection is vital to ensure that local and state authorities are supported to prepare for and respond to emerging outbreaks.

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Authorizing Statute(s): US Code: 42 USC 242k Name of Law: Public Health Service Act
   US Code: 42 USC 242m(d) Name of Law: Public Health Service Act
   US Code: 42 USC 242b Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 98

IC Title	Form No.	Form Name
57.100 NHSN Registration Form	CDC 57.100	NHSN Registration Form
57.101 Facility Contact Information	CDC 57.101	Facility Contact Information
57.103 Patient Safety Component - Annual Hospital Survey	57.103	Patient Safety Component-Annual Hospital Survey
57.104 NHSN Administrator Change Request Form	none	Facility Administrator Change Request
57.105 Group Contact Information	CDC 57.105	Group Contact Information
57.106 Patient Safety Monthly Reporting Plan	57.106	Patient Safety Monthly Reporting Plan
57.108 Primary Bloodstream Infection (BSI)	57.108	Primary Bloodstream Infection (BSI)
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	57.111	Pneumonia (PNEU)
57.112 Ventilator-Associated Event (VAE)	57.112	Ventilator Associated Event (VAE)
57.113 Pediatric Ventilator-Associated Event (PedVAE)	57.113	Pediatric Ventilator-Associated Event (PedVAE)
57.114 Urinary Tract Infection (UTI)	57.114	Urinary Tract infection (UTI)
57.115 Custom Event	CDC 57.115	Custom Event
57.116 Denominators for Neonatal Intensive Care Unit (NICU)	CDC 57.116	PedVAE Optional Denominators Neonatal Intensive Care Unit (NICU)
57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)	CDC 57.117	Denominators for Specialty Care Area (SCA)/Oncology (ONC)
57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA)	CDC 57.118	Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)
57.120 Surgical Site Infection (SSI)	CDC 57.120	Surgical Site Infection
57.121 Denominators for Procedure	57.121	Denominator for Procedure
57.122 HAI Progress Report State Health Department Survey	CDC 55.122	State Health Department HAI Mandate and Validatyion Survey
57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables	57.123	Antimicrobial Use and Resistance (AUR): Microbiology Laboratory Data Monthly Electronic Upload Specification Tables
57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	57.124	Antimicrobial Use and Resistance (AUR): Pharmacy Data Monthly Electronic Upload Specification Tables
57.125 Central Line Insertion Practices Adherence Monitoring Form	CDC 57.125	Central Line Insertion Practices Adherence Monitoring
57.126 MDRO or CDI Infection Event	CDC 57.126	MDRO or CDI Infection Event
57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	CDC 57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Reporting
57.128 Laboratory Identified or CDI MDRO Event	57.128	Laboratory-identified MDRO or CDI Event
57.129_Adult Sepsis	57.129	Adult Sepsis_
57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-IT Initial Set up
57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-IT Yearly Maintenance
57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-Infection Preventionist	57.132	Reporting Plan HOB and HTCDI
57.132 - Patient Safety Digital Reporting Plan (RPS CSV)	57.132	Patient Safety Digital Reporting Plan (RPS CSV)
57.137 Long Term care Facility Component--Annual Facility Survey	CDC 57.137	Long-Term Care Facility Component -- Annual Facility Survey
57.138 Laboratory-Identified MDRO or CDI Event for LTCF	CDC 57.138	Laboratory-identified MDRO or CDI Event for LTCF
57.139 MDRO and CDI Prevention Process Measures Monthly for LTCF	CDC 57.139	MDRO and CDI LabID Event Reporting Monthly Summary Data for LTCF
57.140 Urinary Tract Infection (UTI) for LTCF	57.140	Urinary Tract Infection (UTI) for LTCF
57.141 Monthly Reporting Plan for LTCF	CDC 57.141	Monthly Reporting Plan for LTCF
57.142 Denominators for LTCF Locations	CDC 57.142	Denominators for LTCF
57.143 Prevention Process Measures Monthly Monitoring for LTCF	CDC 57.143	Prevention Process Measures Monthly Monitoring
57.145 - Long Term Care Antimicrobial Use (LTC-AU) Module CDA	57.145	LTC-AU Module
57.150 Patient Safety Component -- Annual Facility Survey for LTAC	57.150	Urinary Tract Infection (UTI) for LTCF
57.151 Patient Safety Component -- Annual Facility Survey for IRF	57.151	Patient Safety Component—Annual Facility Survey for IRF
57.300 Hemovigilance Module Annual Survey -- Acute Care Facility	CDC 57.300	Hemovigilance Module - Annual Survey
57.301 Hemovigilance Module Monthly Reporting Plan	57.301	Hemovigilance Module Monthly Reporting Plan
57.303 Hemovigilance Module Monthly Reporting Denominators	CDC 57.303	Hemovigilance Module Monthly Reporting Denominators
57.305 Hemovigilance Incident	CDC 57.305	Hemovigilance Module Incident
57.306 Hemovigilance Module Annual Facility Survey - Non-acute Care Facility	57.306	Hemovigilance Module Annual Survey - Non-acute Care Facility
57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction	57.307	Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction
57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction	57.308	Hemovigilance Adverse Reaction - Allergic Transfusion Reaction
57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction	CDC 57.309	Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction
57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction	57.310	Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction
57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction	CDC 57.311	Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction
57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction	57.312	Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction
57.313 Hemovigilance Adverse Reaction - Infection	57.313	Hemovigilance Adverse Reaction - Infection
57.314 Hemovigilance Adverse Reaction - Post Transfusion Purpura	57.314	Hwemovilgilance Adverse Reaction - Post Transfusion Purpura
57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea	CDC 57.315	Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea
57.316 Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease	CDC 57.316	Hemovigilance Adverse Reaction - Transfusin Associated Graft vs. Host Disease
57.317 Hemovigilance Adverse Reaction - Transfusion Associated Acute Lung Injury	57.317	Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury
57.318 Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload	CDC 57.318	Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload
57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction	CDC 57.319	Hemovigilance Adverse Reaction - Unknown Transfusion Reaction
57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction	57.320	Hemovigilance Adverse Reaction - Other Transfusion Reaction
57.400 Outpatient Procedure - Annual Facility Survey	CDC 57.400	Outpatient Procedure Component - Annual Facility Survey
57.401 Outpatient Procedure - Monthly Reporting Plan	CDC 57.401	Outpatient Procedure Component - Monthly Reporting Plan
57.402 Outpatient Procedure Component Event	CDC 57.402	Outpatient Procedure - Component Event
57.403 Outpatient Procedure Component - Monthly Denominators and Summary	CDC 57.403	Outpatient Procedure - Monthly Denominators and Summary
57.404 Outpatient Procedure Component - SSI Denominators	57.404	Outpatient Procedure Component - SSI Denominators
57.405 Outpatient Procedure Component - Surgical Site Infection (SSI) Event	CDC 57.405	Outpatient Procedure Component - SSI Denominators
57.500 Outpatient Dialysis Center Practices Survey	57.500	Home Dialysis Center Practices Survey
57.501 Dialysis Monthly Reporting Plan	CDC 57.501	NHSN Registration Form
57.502 Dialysis Event	CDC 57.502	Dialysis Event
57.503 Denominators for Outpatient Dialysis	CDC 57.503	Demominators for Dialysis Event Surveillance
57.504 Prevention Process Measures Monthly Monitoring for Dialysis	CDC 57.504	Prevention Process Measures Monthly Monitoring for Dialysis
57.507 Home Dialysis Center Practices Survey	57.507	Home Dialysis Center Practices Survey
57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Initial Set up	57.600	Reporting Plan LOSMEN Initial Set-up
57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Yearly Maintenance	57.600	Reporting Plan LOSMEN Yearly Maintenance
57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-Infection Preventionist	57.600	Reporting Plan LOSMEN
57.600 - Neonatal Component Late Onset Sepsis Meningitis (LOSMEN) Module CDA Data Collection-Infection Preventionist	57.600	Reporting Plan LOSMEN
57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Initial Set up	57.700	Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE) -IT Initial Set up
57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Yearly Maintenance	57.700	Medication Safety-Digital Measure Reporting Plan (HYPO, HAKI, ORAE) -IT Yearly Maintenance
57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-Infection Preventionist	57.700	Reporting Plan Glycemic Control Module Hypoglycemia
57.701 - Glycemic Control Module-HYPO Annual Survey	57.701	Glycemic Control Module-HYPO Annual Survey
AUR Microbiolgy Data Electronic Upload Specification Tables (Yearly Maintenance)	57.123	Yearly Maintenance (form not used)
AUR Microbiology Data Electronic Upload Specification Tables (Initial Set-up)	57.123	Initial Set-up (form not used)
AUR Pharmacy Data Electronic Upload Specification Tables (Initial Set-up)	57.124	Initial Set-up (form not used)
AUR Pharmacy Data Electronic Upload Specification Tables (Yearly Maintenance)	57.124	Yearly Maintenance (form not used)
All Hazards	57.803	All Hazards
Annual Healthcare Personnel Influenza Vaccination Summary (CSV)	57.214	CSV Submission
Annual Healthcare Personnel Influenza Vaccination Summary (manual)	CDC 57.214	Annual Healthcare Personnel Influenza Vaccination Summary
Bed Capacity-IT Initial Set Up	57.802	Bed Capacity-IT Initial Set Up
Billing Code Data: 837I Upload	57.800	Billing Code Data
External Validation Summary Report	57.801	External Validation Summary Report
Hemovigilance Module Monthly Incident Summary	CDC 57.302	Hemovigilance Module Monthly Incident Summary
Late Onset Sepsis/Meningitis Denominator Form: Data Table (Monthly)	57.601	Late Onset Sepsis/ Meningitis Denominator Form: Data Table for monthly electronic upload
Long Term Care Facility Component - Respiratory Tract Infection	57.602	Long-Term Care Facility Component – Respiratory Tract Infection
Monthly Survey Patient Days & Nurse Staffing	57.408	Monthly Survey Patient Days & Nurse Staffing
NHSN Help Desk Customer Satisfaction Survey	57.102	NHSN Help Desk Customer Satisfaction Survey
Pathogens of High Consequence	57.130, 0920-0666	Pathogens of High Consequence ,   Form 57.130 Pathogens of High Consequence_20DEC2024
Patient Safety Attestation	57.133	Patient Safety Attestation
Seasonal Survey on Influenza Vaccination Programs for Healthcare Personnel	57.215	Seasonal Survey on Influenza Vaccination Programs for Healthcare Personnel
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities	CDC 57.211	Weekly HCP Influenza Vaccination Cumulative Summary Non-Long-Term Care Facilities
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities (CSV)	57.211	CSV Submission

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	5,896,361	5,896,361	0	0	0	0
Annual Time Burden (Hours)	4,508,255	4,397,234	0	111,021	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This Emergency Revision Request is submitted to add three (3) additional diseases to the data collection, Influenza A (H5), Marburg, and Oropouche. Data will be collected following modification of the previously approved Form 57.130 - Pathogens of High Consequence. An additional 111,021 burden hours will be added to the collection.

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Annual Cost to Federal Government: $49,994,530

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/20/2024

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