The National Healthcare Safety Network (NHSN)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CDC 57.106 Patient Safety Monthly Reporting Plan	Form and Instruction	Unchanged	Available
Form 57.136 Long-Term Care Facility Component – Respiratory Tract Infection	Form and Instruction	Unchanged	Available
Form 57.104 FAChangeRequest_BLANK	Form and Instruction	Unchanged	Repair queued
Form CDC 55.122 State Health Department HAI Mandate and Validatyion Survey	Form	Unchanged	Available
Form 57.404 Outpatient Procedure Component - SSI Denominators	Form	Unchanged	Available
Form 57.404 Outpatient Procedure Component - SSI Denominators	Form	Unchanged	Available
Form 57.507 Home Dialysis Center Practices Survey	Form	Unchanged	Available
Form 57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction	Form	Unchanged	Available
Form CDC 57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction	Form	Unchanged	Available
Form 57.318 Hemoviligance Adverse Reaction - Transfusion Associated Circulatory Overload	Form	Unchanged	Available
Form 57.317 Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury	Form	Unchanged	Available
Form CDC 57.316 Hemovigilance Adverse Reaction - Transfusin Associated Graft vs. Host Disease	Form	Unchanged	Available
Form CDC 57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea	Form	Unchanged	Available
Form 57.314 Hwemovilgilance Adverse Reaction - Post Transfusion Purpura	Form	Unchanged	Available
Form 57.313 Hemovigilance Adverse Reaction - Infection	Form	Unchanged	Repair queued
Form 57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction	Form	Unchanged	Available
Form CDC 57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction	Form	Unchanged	Available
Form 57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction	Form	Unchanged	Available
Form CDC 57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction	Form	Unchanged	Available
Form 57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction	Form	Unchanged	Available
Form 57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction	Form	Unchanged	Available
Form 57.306 Hemovigilance Module Annual Survey - Non-acute Care Facility	Form	Unchanged	Available
Form 57.129 Adult Sepsis_	Form	Unchanged	Repair queued
Form CDC 57.115 Custom Event	Form	Modified	Available
Form CDC 57.113 Pediatric Ventilator-associated Event	Form	Modified	Available
Form CDC 57.506 Dialysis Patient Influenza Vaccination Denominator	Form	Unchanged	Available
Form CDC 57.505 Dialysis Patient Influenza Vaccination	Form	Unchanged	Available
Form CDC 57.504 Prevention Process Measures Monthly Monitoring for Dialysis	Form	Unchanged	Available
Form CDC 57.501 NHSN Registration Form	Form	Unchanged	Available
Form CDC 57.403 Outpatient Procedure - Monthly Denominators and Summary	Form	Unchanged	Available
Form CDC 57.402 Outpatient Procedure - Event	Form	Unchanged	Available
Form CDC 57.401 Outpatient Procedure Component - Monthly Reporting Plan	Form	Unchanged	Available
Form CDC 57.400 Outpatient Procedure Component - Annual Facility Survey	Form	Unchanged	Available
Form CDC 57.151 Patient Safety Component - Annual Facility Survey for IRF	Form	Unchanged	Available
Form CDC 57.150 Patient Safety Component - Annual Facility Survey for LTAC	Form	Unchanged	Available
Form CDC 57.143 Prevention Process Measures Monthly Monitoring	Form	Unchanged	Available
Form CDC 57.142 Denominators for LTCF	Form	Unchanged	Available
Form CDC 57.141 Monthly Reporting Plan for LTCF	Form	Unchanged	Available
Form CDC 57.112 Ventilator-associated event	Form	Modified	Available
Form CDC 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	Form	Unchanged	Available
Form CDC 57.138 Laboratory-identified MDRO or CDI Event for LTCF	Form	Unchanged	Available
Form CDC 57.137 Long-Term Care Facility Component -- Annual Facility Survey	Form	Unchanged	Available
Form CDC 57.305 Hemovigilance Module Incident	Form	Unchanged	Available
Form CDC 57.303 Hemovigilance Module Monthly Reporting Denominators	Form	Unchanged	Available
Form CDC 57.301 Hemovigilance Module Monthly Reporting Plan	Form	Unchanged	Available
Form CDC 57.300 Hemovigilance Module - Annual Survey	Form	Unchanged	Available
Form CDC 57.200 Healthcare Personnel Safety - Annual Facility Survey	Form	Unchanged	Available
Form CDC 57.204 Healthcare Worker Demographic Data	Form	Unchanged	Available
Form CDC 57.206 Healthcare Worker Prophylaxis/Treatment	Form	Unchanged	Available
Form CDC 57.205 Exposure to Blood/Body Fluids	Form	Unchanged	Available
Form CDC 57.105 Group Contact Information	Form	Unchanged	Available
Form CDC 57.140 Urinary Tract Infection (UTI) for LTCF	Form	Unchanged	Available
Form CDC 57.103 Annual Hospital Survey - Patient Safety Component	Form	Unchanged	Available
Form CDC 57.101 Facility Contact Information	Form	Unchanged	Available
Form CDC 57.124 Antimicrobial Use and Resistance (AUR): Pharmacy Date Monthly Electronice Upload Specification Tables	Form	Modified	Available
Form 0920-0666 CDC 57.1 AUR - Pharmacy Electronic Upload - Remdesivir	Form	Modified	Available
Form CDC 57.123 Antimicrobial Use and Resistance (AUR): Microbiology Laboratory Data Monthly Electronic Upload Specification Tables	Form	Unchanged	Available
Form CDC 57.100 NHSN Registration Form	Form	Unchanged	Available
Form CDC 57.121 Denominatoir for Procedure	Form	Unchanged	Available
Form CDC 57.128 Rev 7, Lab ID Event	Form and Instruction	Unchanged	Available
Form CDC 57.128 Laboratory-identified MDRO or CDI Event	Form	Unchanged	Available
Form CDC 57.120 Surgical site infection	Form	Modified	Available
Form CDC 57.126 MDRO or CDI Infection Event	Form	Unchanged	Available
Form CDC 57.503 Demominators for Dialysis Event Surveillance	Form	Unchanged	Available
Form CDC 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Reporting	Form	Unchanged	Available
Form CDC 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)	Form	Unchanged	Available
Form CDC 57.207 Follow-up Laboratory Testing	Form	Unchanged	Available
Form CDC 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)	Form	Unchanged	Available
Form CDC 57.125 Central Line Insertion Practices Adherence Monitoring	Form	Unchanged	Available
Form CDC 57.116 PedVAE Optional Denominators Neonatal Intensive Care Unit (NICU)	Form	Unchanged	Available
Form CDC 57.114 Urinary tract infection	Form	Modified	Available
Form CDC 57.210 HCW Prophylaxis/Treatment-Influenza	Form	Unchanged	Available
Form CDC 57.111 Pneumonia	Form	Modified	Available
Form CDC 57.502 Dialysis Event	Form	Unchanged	Available
Form CDC 57.108 Primary blood stream infection	Form	Modified	Available
Form CDC 57.500 Outpatient Dialysis Center Practices Survey	Form	Unchanged	Available
Form CDC 57.203 Healthcare Personnel Safety Monthly Reporting Plan	Form	Unchanged	Available
Change Memo for COVID HAI 060320_AW.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-06-08	Available
Change Memo for COVID HAI 060320.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-06-04	Available
CMS Cross walk 11.16.18.docx	Supplementary Document	Uploaded 2018-11-29	Available
I. PIA.pdf	Supplementary Document	Uploaded 2018-10-09	Available
2. NHSN 308d Request for Extension and Ammendment.docx	Supplementary Document	Uploaded 2017-09-25	Available
1. NHSN 308d Approval 2015.pdf	Supplementary Document	Uploaded 2017-09-25	Available
1. NHSN 308d Approval 2015.pdf	Supplementary Document	Uploaded 2018-10-09	Available
2. NHSN - Report of End of Human Research Review 0.1253.docx	Supplementary Document	Uploaded 2018-10-09	Available
Closure CDC Protocol # 4062.docx	Supplementary Document	Uploaded 2018-10-09	Available
6. Inpatient Psychiatric Facilities - FLU.pdf	Supplementary Document	Uploaded 2018-10-09	Available
5. Ambulatory Surgery Centers & Outpatient Acute Care Facility Departments - Flu.pdf	Supplementary Document	Uploaded 2018-10-09	Available
4. Dialysis Facilities - Dialysis Event, FLU.pdf	Supplementary Document	Uploaded 2018-10-09	Available
3. Inpatient Rehabiliation Facilities - CAUTI, MRSA LabID, CDI LabID, Flu.pdf	Supplementary Document	Uploaded 2018-10-09	Available
2. Antimicrobial Use and Resistance.pdf	Supplementary Document	Uploaded 2018-10-03	Available
1. NHSN Forms used for CMS QRPs State Mandated Reporting FINAL V3.docx	Supplementary Document	Uploaded 2018-10-03	Available
4. Revision of Estimated Annual Cost Burden.docx	Supplementary Document	Uploaded 2019-10-10	Available
3. Revision of Estimated Annual Burden Hours.docx	Supplementary Document	Uploaded 2019-10-10	Available
2. Itemized IC Revisions and Justifications LW clean.docx	Supplementary Document	Uploaded 2019-12-02	Available
1. Explanations and justifications.docx	Supplementary Document	Uploaded 2019-10-10	Available
Published 60dy FRN.pdf	Supplementary Document	Uploaded 2019-10-10	Available
0920-0666 Sup Sta B.docx	Supporting Statement B	Uploaded 2019-10-10	Available
3. 42 USC 242m.PDF	Supplementary Document	Uploaded 2018-10-09	Available
2. 42 USC 242k.PDF	Supplementary Document	Uploaded 2018-10-09	Available
1. 42 USC 242b.PDF	Supplementary Document	Uploaded 2018-10-09	Available
0920-0666_ Sup Sta A ICRO REVIEW 2 9.17.19.docx	Supporting Statement A	Uploaded 2019-10-10	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
7134	57.106 Patient Safety Monthly Reporting Plan	Form and Instruction	Unchanged	Patient Safety Monthly Reporting Plan
238093	57.136 Long Term Care Facility Component - Respiratory Tract Infection	Form and Instruction	Unchanged	Long-Term Care Facility Component – Respiratory Tract Infection
237430	57.104 NHSN Administrator Change Request Form	Form and Instruction	Unchanged	FAChangeRequest_BLANK
233214	57.122 HAI Progress Report State Health Department Survey	Form	Unchanged	State Health Department HAI Mandate and Validatyion Survey
228154	57.405 Outpatient Procedure Component - Surgical Site Infection (SSI) Event	Form	Unchanged	Outpatient Procedure Component - SSI Denominators
228153	57.404 Outpatient Procedure Component - SSI Denominators	Form	Unchanged	Outpatient Procedure Component - SSI Denominators
222908	57.507_HomeDialysisSurv_BLA	Form	Unchanged	Home Dialysis Center Practices Survey
222907	57.320_HV AR-Other_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Other Transfusion Reaction
222906	57.319_HV AR-UNK_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Unknown Transfusion Reaction
222905	57.318_HV AR-TACO_BLANK	Form	Unchanged	Hemoviligance Adverse Reaction - Transfusion Associated Circulatory Overload
222904	57.317_HV AR-TRALI_BLAN	Form	Unchanged	Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury
222903	57.316_HV AR-TAGVHD_BLAN	Form	Unchanged	Hemovigilance Adverse Reaction - Transfusin Associated Graft vs. Host Disease
222902	57.315_HV AR-TAD_BLAN	Form	Unchanged	Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea
222901	57.314_HV AR-PTP_BLAN	Form	Unchanged	Hwemovilgilance Adverse Reaction - Post Transfusion Purpura
222900	57.313_HV AR-Infection_BLAN	Form	Unchanged	Hemovigilance Adverse Reaction - Infection
222899	57.312_HV AR-HTR_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction
222898	57.311_HV AR-FNHTR_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction
222897	57.310_HV AR-DSTR_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction
222896	57.309_HV AR-DHTR_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction
222895	57.308_HV AR-Allergic_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Allergic Transfusion Reaction
222894	57.307_HV AR-AHTR_BLANK	Form	Unchanged	Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction
222893	57.306_HV Annual Facility Sur	Form	Unchanged	Hemovigilance Module Annual Survey - Non-acute Care Facility
222892	57.129_Adult Sepsis_BLANK	Form	Unchanged	Adult Sepsis_
222891	57.115_CUS_BLANK	Form	Modified	Custom Event
222890	57.113 Pediatric Ventilator-Associated Event (PedVAE)	Form	Modified	Pediatric Ventilator-associated Event
208411	57.506 Dialysis Patient Influenza Vaccination Denominator	Form	Unchanged	Dialysis Patient Influenza Vaccination Denominator
208410	57.505 Dialysis Patient Influenza Vaccination	Form	Unchanged	Dialysis Patient Influenza Vaccination
208409	57.504 Prevention Process Measures Monthly Monitoring for Dialysis	Form	Unchanged	Prevention Process Measures Monthly Monitoring for Dialysis
208408	57.501 Dialysis Monthly Reporting Plan	Form	Unchanged	NHSN Registration Form
208407	57.403 Outpatient Procedure Component - Monthly Denominators and Summary	Form	Unchanged	Outpatient Procedure - Monthly Denominators and Summary
208406	57.402 Outpatient Procedure Component Event	Form	Unchanged	Outpatient Procedure - Event
208405	57.401 Outpatient Procedure - Monthly Reporting Plan	Form	Unchanged	Outpatient Procedure Component - Monthly Reporting Plan
208404	57.400 Outpatient Procedure - Annual Facility Survey	Form	Unchanged	Outpatient Procedure Component - Annual Facility Survey
200382	57.151 Patient Safety Component -- Annual Facility Survey for IRF	Form	Unchanged	Patient Safety Component - Annual Facility Survey for IRF
200381	57.150 Patient Safety Component -- Annual Facility Survey for LTAC	Form	Unchanged	Patient Safety Component - Annual Facility Survey for LTAC
200380	57.143 Prevention Process Measures Monthly Monitoring for LTCF	Form	Unchanged	Prevention Process Measures Monthly Monitoring
200379	57.142 Denominators for LTCF Locations	Form	Unchanged	Denominators for LTCF
200378	57.141 Monthly Reporting Plan for LTCF	Form	Unchanged	Monthly Reporting Plan for LTCF
200377	57.112 Ventilator-Associated Event (VAE)	Form	Modified	Ventilator-associated event
197543	57.139 MDRO and CDI Prevention Process Measures Monthly for LTCF	Form	Unchanged	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
197542	57.138 Laboratory-Identified MDRO or CDI Event for LTCF	Form	Unchanged	Laboratory-identified MDRO or CDI Event for LTCF
197541	57.137 Long Term care Facility Component--Annual Facility Survey	Form	Unchanged	Long-Term Care Facility Component -- Annual Facility Survey
190364	57.305 Hemovigilance Incident	Form	Unchanged	Hemovigilance Module Incident
190363	57.303 Hemovigilance Module Monthly Reporting Denominators	Form	Unchanged	Hemovigilance Module Monthly Reporting Denominators
190361	57.301 Hemovigilance Module Monthly Reporting Plan	Form	Unchanged	Hemovigilance Module Monthly Reporting Plan
190360	57.300 Hemovigilance Module Annual Survey -- Acute Care Facility	Form	Unchanged	Hemovigilance Module - Annual Survey
183582	57.200 Healthcare Personnel Safety Component Facility Survey	Form	Unchanged	Healthcare Personnel Safety - Annual Facility Survey
183579	57.204 Healthcare Worker Demographic Data	Form	Unchanged	Healthcare Worker Demographic Data
183578	57.206 Healthcare Worker Prophylaxis/Treatment	Form	Unchanged	Healthcare Worker Prophylaxis/Treatment
183577	57.205 Exposure to Blood and Body Fluids	Form	Unchanged	Exposure to Blood/Body Fluids
183576	57.105 Group Contact Information	Form	Unchanged	Group Contact Information
183573	57.140 Urinary Tract Infection (UTI) for LTCF	Form	Unchanged	Urinary Tract Infection (UTI) for LTCF
183572	57.103 Patient Safety Component - Annual Hospital Survey	Form	Unchanged	Annual Hospital Survey - Patient Safety Component
183570	57.101 Facility Contact Information	Form	Unchanged	Facility Contact Information
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	Form	Modified	Antimicrobial Use and Resistance (AUR): Pharmacy Date Monthly Electronice Upload Specification Tables
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	Form	Modified	AUR - Pharmacy Electronic Upload - Remdesivir
183566	57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables	Form	Unchanged	Antimicrobial Use and Resistance (AUR): Microbiology Laboratory Data Monthly Electronic Upload Specification Tables
183565	57.100 NHSN Registration Form	Form	Unchanged	NHSN Registration Form
183564	57.121 Denominators for Procedure	Form	Unchanged	Denominatoir for Procedure
183563	57.128 Laboratory Identified or CDI MDRO Event	Form and Instruction	Unchanged	Lab ID Event
183563	57.128 Laboratory Identified or CDI MDRO Event	Form	Unchanged	Laboratory-identified MDRO or CDI Event
183562	57.120 Surgical Site Infection (SSI)	Form	Modified	Surgical site infection
183561	57.126 MDRO or CDI Infection Event	Form	Unchanged	MDRO or CDI Infection Event
183560	57.503 Denominators for Outpatient Dialysis	Form	Unchanged	Demominators for Dialysis Event Surveillance
183559	57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	Form	Unchanged	MDRO and CDI Prevention Process and Outcome Measures Monthly Reporting
183558	57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA)	Form	Unchanged	Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)
183557	57.207 Follow-up Laboratory Testing	Form	Unchanged	Follow-up Laboratory Testing
183556	57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)	Form	Unchanged	Denominators for Specialty Care Area (SCA)/Oncology (ONC)
183555	57.125 Central Line Insertion Practices Adherence Monitoring Form	Form	Unchanged	Central Line Insertion Practices Adherence Monitoring
183554	57.116 Denominators for Neonatal Intensive Care Unit (NICU)	Form	Unchanged	PedVAE Optional Denominators Neonatal Intensive Care Unit (NICU)
183551	57.114 Urinary Tract Infection (UTI)	Form	Modified	Urinary tract infection
183550	57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	Form	Unchanged	HCW Prophylaxis/Treatment-Influenza
183549	57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	Form	Modified	Pneumonia
183547	57.502 Dialysis Event	Form	Unchanged	Dialysis Event
183545	57.108 Primary Bloodstream Infection (BSI)	Form	Modified	Primary blood stream infection
183544	57.500 Outpatient Dialysis Center Practices Survey	Form	Unchanged	Outpatient Dialysis Center Practices Survey
183543	57.203 Healthcare Personnel Safety Reporting Plan	Form	Unchanged	Healthcare Personnel Safety Monthly Reporting Plan

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 202006-0920-003
Status: Historical Active	Previous ICR Reference No: 201908-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0666-20PC
Title: The National Healthcare Safety Network (NHSN)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/11/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/04/2020
Terms of Clearance: Previous terms continue: Approved consistent with the understanding that CDC will continue to add language to its website and reports that clearly caveats the interpretation of longitudinal trends due to changes in the number and characteristics of participating hospitals, particularly changes driven by Medicare and State-level reporting.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	12/31/2022	12/31/2022
Responses	5,351,785	0	5,352,360
Time Burden (Hours)	3,118,332	0	3,113,631
Cost Burden (Dollars)	100,998,460	0	101,009,102

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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. Since 2005, the (NHSN) provides healthcare facilities, states, regions, and the nation with the data desired to identify healthcare-associated infection (HAI) problem areas, measure the progress of prevention efforts, and ultimately eliminate HAIs in conjunction with driving the achievement of the overall mission of the Department of Health and Human Services (DHHS). Enrollment in NHSN has continuously increased, with over 25,000 enrolled healthcare facilities and 21,700 actively reporting healthcare facilities across the U.S. Of these, there are over 5,000 acute care facilities; 7,800 dialysis facilities; 600 long-term acute care facilities; 1,100 inpatient rehabilitation facilities; 800 inpatient psychiatric facilities; 3,100 long-term care facilities; and 6,000 ambulatory surgery facilities. The proposed revisions included in this ICR are designed to (1) increase the overall attainment of CDC’s NHSN HAI surveillance goals and event reporting coverage for all facility types that are active and reporting data to NHSN; (2) to enhance NHSN surveillance and data quality practices exercised by NHSN users and facilities alike; (3) to introduce the new; Neonatal Component, NHSN Facility Administrator Change Request Form, and Long-term Care Facility Form. (4) To update and revise existing survey questions within NHSN’s components by implementing elements of user feedback that has been further analyzed for NHSN and its partnering organizations, intended to advance NHSN data reporting quality for HAI events, dialysis events, and hemovigilance adverse reaction protocols. Lastly, the proposed revisions will further improve the overall quality of existing data collection forms, which are intended to ensure complete data reporting into CDC’s NHSN by all participating facilities. This request for change is to add COVID-19 related data elements.

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Authorizing Statute(s): US Code: 42 USC 242b Name of Law: Public Health Service Act
   US Code: 42 USC 242m(d) Name of Law: Public Health Service Act
   US Code: 42 USC 242k 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
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 26113	06/05/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 53441	10/07/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 75

table that charts list of burden

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	CDC 57.103	Annual Hospital Survey - Patient Safety Component
57.104 NHSN Administrator Change Request Form	57.104	FAChangeRequest_BLANK
57.105 Group Contact Information	CDC 57.105	Group Contact Information
57.106 Patient Safety Monthly Reporting Plan	CDC 57.106	Patient Safety Monthly Reporting Plan
57.108 Primary Bloodstream Infection (BSI)	CDC 57.108	Primary blood stream infection
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	CDC 57.111	Pneumonia
57.112 Ventilator-Associated Event (VAE)	CDC 57.112	Ventilator-associated event
57.113 Pediatric Ventilator-Associated Event (PedVAE)	CDC 57.113	Pediatric Ventilator-associated Event
57.114 Urinary Tract Infection (UTI)	CDC 57.114	Urinary tract infection
57.115_CUS_BLANK	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	CDC 57.121	Denominatoir 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	CDC 57.123	Antimicrobial Use and Resistance (AUR): Microbiology Laboratory Data Monthly Electronic Upload Specification Tables
57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	0920-0666 CDC 57.124, CDC 57.124	Antimicrobial Use and Resistance (AUR): Pharmacy Date Monthly Electronice Upload Specification Tables ,   AUR - Pharmacy Electronic Upload - Remdesivir
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	CDC 57.128, CDC 57.128 Rev 7, v8.5	Laboratory-identified MDRO or CDI Event ,   Lab ID Event
57.129_Adult Sepsis_BLANK	57.129	Adult Sepsis_
57.136 Long Term Care Facility Component - Respiratory Tract Infection	57.136	Long-Term Care Facility Component – Respiratory Tract Infection
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 Prevention Process Measures Monthly Monitoring for LTCF
57.140 Urinary Tract Infection (UTI) for LTCF	CDC 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
57.150 Patient Safety Component -- Annual Facility Survey for LTAC	CDC 57.150	Patient Safety Component - Annual Facility Survey for LTAC
57.151 Patient Safety Component -- Annual Facility Survey for IRF	CDC 57.151	Patient Safety Component - Annual Facility Survey for IRF
57.200 Healthcare Personnel Safety Component Facility Survey	CDC 57.200	Healthcare Personnel Safety - Annual Facility Survey
57.203 Healthcare Personnel Safety Reporting Plan	CDC 57.203	Healthcare Personnel Safety Monthly Reporting Plan
57.204 Healthcare Worker Demographic Data	CDC 57.204	Healthcare Worker Demographic Data
57.205 Exposure to Blood and Body Fluids	CDC 57.205	Exposure to Blood/Body Fluids
57.206 Healthcare Worker Prophylaxis/Treatment	CDC 57.206	Healthcare Worker Prophylaxis/Treatment
57.207 Follow-up Laboratory Testing	CDC 57.207	Follow-up Laboratory Testing
57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	CDC 57.210	HCW Prophylaxis/Treatment-Influenza
57.300 Hemovigilance Module Annual Survey -- Acute Care Facility	CDC 57.300	Hemovigilance Module - Annual Survey
57.301 Hemovigilance Module Monthly Reporting Plan	CDC 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_HV Annual Facility Sur	57.306	Hemovigilance Module Annual Survey - Non-acute Care Facility
57.307_HV AR-AHTR_BLANK	57.307	Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction
57.308_HV AR-Allergic_BLANK	57.308	Hemovigilance Adverse Reaction - Allergic Transfusion Reaction
57.309_HV AR-DHTR_BLANK	CDC 57.309	Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction
57.310_HV AR-DSTR_BLANK	57.310	Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction
57.311_HV AR-FNHTR_BLANK	CDC 57.311	Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction
57.312_HV AR-HTR_BLANK	57.312	Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction
57.313_HV AR-Infection_BLAN	57.313	Hemovigilance Adverse Reaction - Infection
57.314_HV AR-PTP_BLAN	57.314	Hwemovilgilance Adverse Reaction - Post Transfusion Purpura
57.315_HV AR-TAD_BLAN	CDC 57.315	Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea
57.316_HV AR-TAGVHD_BLAN	CDC 57.316	Hemovigilance Adverse Reaction - Transfusin Associated Graft vs. Host Disease
57.317_HV AR-TRALI_BLAN	57.317	Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury
57.318_HV AR-TACO_BLANK	57.318	Hemoviligance Adverse Reaction - Transfusion Associated Circulatory Overload
57.319_HV AR-UNK_BLANK	CDC 57.319	Hemovigilance Adverse Reaction - Unknown Transfusion Reaction
57.320_HV AR-Other_BLANK	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 - 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	57.404	Outpatient Procedure Component - SSI Denominators
57.500 Outpatient Dialysis Center Practices Survey	CDC 57.500	Outpatient 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
57.505 Dialysis Patient Influenza Vaccination	CDC 57.505	Dialysis Patient Influenza Vaccination
57.506 Dialysis Patient Influenza Vaccination Denominator	CDC 57.506	Dialysis Patient Influenza Vaccination Denominator
57.507_HomeDialysisSurv_BLA	57.507	Home Dialysis Center Practices Survey

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	5,351,785	5,352,360	0	-575	0	0
Annual Time Burden (Hours)	3,118,332	3,113,631	0	4,701	0	0
Annual Cost Burden (Dollars)	100,998,460	101,009,102	0	-10,642	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 change request includes edits to 7 forms to allow for COVID-19-related information collection. The burden was increased by 1 minute per response for each form totaling 4701 additional hours.

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Annual Cost to Federal Government: $18,045,604

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: 06/04/2020

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