The National Healthcare Safety Network (NHSN)

Forms and Documents

Document	Type	Status	Availability
Form 57.106 57.106 Patient Safety Monthly Reporting Plan	Form	Modified	Repair queued
Form 57.600 57.600 State Health Department Validation Record	Form	New	Available
Form 57.506 57.506 Dialysis Patient Influenza Vaccination Denominator	Form	New	Repair queued
Form 57.505 57.505 Dialysis Patient Influenza Vaccination	Form	New	Repair queued
Form 57.504 57.504 Prevention Process Measures Monthly Monitoring for Dialysis	Form	New	Available
Form 57.501 57.501 Dialysis Monthly Reporting Plan	Form	New	Available
Form 57.403 57.403 Outpatient Procedure - Monthly Denominators and Summary	Form	New	Repair queued
Form 57.402 57.402 Outpatient Procedure - Event	Form	New	Repair queued
Form 57.401 57.401 Outpatient Procedure - Monthly Reporting Plan	Form	New	Repair queued
Form 57.400 57.400 Outpatient Procedure - Annual Facility Survey	Form	New	Available
Form 57.151 57.151 Patient Safety Component -- Annual Facility Survey for IRF	Form	Modified	Repair queued
Form 57.150 57.150 Patient Safety Component -- Annual Facility Survey for LTAC	Form	Modified	Available
Form 57.143 57.143 Prevention Process Measures Monthly Monitoring for LTCF	Form	Modified	Repair queued
Form 57.142 57.142 Denominators for LTCF Locations	Form	Modified	Available
Form 57.141 57.141 Monthly Reporting Plan for LTCF	Form	Modified	Repair queued
Form 57.112 57.112 Ventilator-Associated Event (VAE)	Form	Modified	Available
Form 57.139 57.139 MDRO and CDI Monthly Monitoring for LTCF	Form	Modified	Repair queued
Form 57.138 57.138 Laboratory-Identified MDRO or CDI Event for LTCF	Form	Modified	Available
Form 57.137 57.137 Long Term care Facility Component--Annual Facility Survey	Form	Modified	Available
Form 57.304 57.304 Hemovigilance Module Adverse Reaction	Form	Modified	Available
Form 57.305 57.305 Hemovigilance Incident	Form	Modified	Available
Form 57.303 57.303 Hemovigilance Module Monthly Reporting Denominators	Form	Modified	Repair queued
Form 57.301 57.301 Hemovigilance Module Monthly Reporting Plan	Form	Modified	Repair queued
Form 57.300 57.300 Hemovigilance Module Annual Facility Survey	Form	Modified	Repair queued
Form 57.200 57.200 Healthcare Personnel Safety Component Facility Survey	Form	Modified	Available
Form 57.204 57.204 Healthcare Worker Demographic Data	Form	Modified	Repair queued
Form 57.206 57.206 Healthcare Worker Prophylaxis/Treatment	Form	Modified	Repair queued
Form 57.205 57.205 Exposure to Blood and Body Fluids	Form	Modified	Available
Form 57.105 57.105 Group Contact Information	Form	Modified	Repair queued
Form 57.140 57.140 Urinary Tract Infection (UTI) for LTCF	Form	Modified	Repair queued
Form 57.103 57.103 Patient Safety Component - Annual Hospital Survey	Form	Modified	Repair queued
Form 57.131 57.131 Vaccination Monthly Monitoring Form - Patient-Level Method	Form	Modified	Available
Form 57.101 57.101 Facility Contact Information	Form	Modified	Repair queued
Form 57.133 57.133 Patient Vaccination	Form	Modified	Available
Form 57.124 57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	Form and Instruction	Modified	Repair queued
Form 57.130 57.130 Vaccination Monthly Monitoring Form - Summary Method	Form	Modified	Repair queued
Form 57.123 57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables	Form	Modified	Repair queued
Form 57.100 57.100 NHSN Registration Form	Form	Modified	Available
Form 57.121 57.121 Denominators for Procedure	Form	Modified	Repair queued
Form 57.128 57.128 Laboratory Identified or CDI MDRO Event	Form	Modified	Repair queued
Form 57.120 57.120 Surgical Site Infection (SSI)	Form	Modified	Repair queued
Form 57.126 57.126 MDRO or CDI Infection Event	Form	Modified	Available
Form 57.503 57.503 Denominators for Outpatient Dialysis	Form	Modified	Repair queued
Form 57.127 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	Form	Modified	Available
Form 57.118 57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA)	Form	Modified	Available
Form 57.207 57.207 Follow-up Laboratory Testing	Form	Modified	Available
Form 57.117 57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)	Form	Modified	Available
Form 57.125 57.125 Central Line Insertion Practices Adherence Monitoring Form	Form	Modified	Repair queued
Form 57.116 57.116 Denominators for Neonatal Intensive Care Unit (NICU)	Form	Modified	Available
Form 57.114 57.114 Urinary Tract Infection (UTI)	Form	Modified	Available
Form 57.210 57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	Form	Modified	Repair queued
Form 57.111 57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	Form	Modified	Available
Form 57.502 57.502 Dialysis Event	Form	Modified	Repair queued
Form 57.108 57.108 Primary Bloodstream Infection (BSI)	Form	Modified	Available
Form 57.500 57.500 Outpatient Dialysis Center Practices Survey	Form	Modified	Repair queued
Form 57.203 57.203 Healthcare Personnel Safety Reporting Plan	Form	Modified	Repair queued
4. Ambulatory Surgical Centers - FLU.PDF	Supplementary Document	Uploaded 2013-09-11	Available
1. Acute Care & Long-term Acute Care Hos.pdf	Supplementary Document	Uploaded 2013-09-11	Available
0920-0666 Revision June 2013 Supporting Statement Part B.DOCX	Supporting Statement B	Uploaded 2013-08-21	Repair queued
4062 Closure of Protocol.msg	Supplementary Document	Uploaded 2013-08-21	Repair queued
2. NHSN - Report of End of Human Research Review 0.1253.docx	Supplementary Document	Uploaded 2013-08-21	Repair queued
2. NHSN 308d Approval Memo 2010.pdf	Supplementary Document	Uploaded 2013-08-21	Available
1. NHSN 308d Approval 2010.pdf	Supplementary Document	Uploaded 2013-08-21	Repair queued
3. NHSN 308d Request for Extension and Amendment.docx	Supplementary Document	Uploaded 2013-08-21	Repair queued
3. Dialysis Facilities - Dialysis Event.pdf	Supplementary Document	Uploaded 2013-08-21	Available
2. Inpatient Rehabilitation Facilities - CAUTI.PDF	Supplementary Document	Uploaded 2013-08-21	Repair queued
4. Revision of Estimated Annual Cost Burden.docx	Supplementary Document	Uploaded 2013-08-21	Available
2. Itemized IC Revisions and Justifications.docx	Supplementary Document	Uploaded 2013-08-21	Repair queued
1. Explanations and justifications for proposed revisions to OMB 0920-0666.docx	Supplementary Document	Uploaded 2013-08-21	Repair queued
3. Revision of Estimated Annual Burden Hours.docx	Supplementary Document	Uploaded 2013-08-21	Repair queued
3. 42 USC 242m.pdf	Supplementary Document	Uploaded 2013-08-21	Available
2. 42 USC 242k.pdf	Supplementary Document	Uploaded 2013-08-21	Repair queued
1. 42 USC 242b.pdf	Supplementary Document	Uploaded 2013-08-21	Available
15. State Validation Record.pdf	Supplementary Document	Uploaded 2013-08-22	Available
7. Dialysis Patient Influenza Vaccination.pdf	Supplementary Document	Uploaded 2013-08-22	Repair queued
13. Outpatient Procedure Component.pdf	Supplementary Document	Uploaded 2013-08-22	Repair queued
13. Outpatient Procedure Component.pdf	Supplementary Document	Uploaded 2013-08-22	Repair queued
13. Outpatient Procedure Component.pdf	Supplementary Document	Uploaded 2013-08-22	Available
13. Outpatient Procedure Component.pdf	Supplementary Document	Uploaded 2013-08-22	Repair queued
18. Ventilator Associated Event.pdf	Supplementary Document	Uploaded 2013-08-21	Available
19. Ventilator Associated Pneumonia.pdf	Supplementary Document	Uploaded 2013-08-21	Available
9. LTCF MDRO CDI.pdf	Supplementary Document	Uploaded 2013-08-21	Repair queued
10. LTCF Prevention Process Measures.pdf	Supplementary Document	Uploaded 2013-08-21	Available
2. Bioviglance Component.pdf	Supplementary Document	Uploaded 2013-08-22	Available
1-10-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Available
1-10-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Available
Appendix-G-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
Appendix-F-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
Appendix-E-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
Appendix-D-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
Appendix-C-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Available
Appendix-B-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
Appendix-A-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Available
1-10-BV-Protocol.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
8. Healthcare Personnel Exposure.pdf	Supplementary Document	Uploaded 2013-08-21	Available
11. LTCF UTI.pdf	Supplementary Document	Uploaded 2013-08-21	Available
14. Patient Safety Monthly Reporting Plan.pdf	Supplementary Document	Uploaded 2013-08-21	Available
17. Vaccination (IC# 26, 28, 30).pdf	Supplementary Document	Uploaded 2013-08-21	Repair queued
1. Antimicrobial Use & Resistance.pdf	Supplementary Document	Uploaded 2013-08-21	Available
1. Antimicrobial Use & Resistance.pdf	Supplementary Document	Uploaded 2013-08-21	Repair queued
F1.17PSC_NosInfDef.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
F1.16PSC_KeyTerms.pdf	Supplementary Document	Uploaded 2011-12-05	Repair queued
F1.15PSC_LocationsDescriptions.pdf	Supplementary Document	Uploaded 2011-12-05	Available
F1.2PSC_IdentifyingHAIs_NHSN.pdf	Supplementary Document	Uploaded 2011-12-05	Available
F1.1PSC_Overview.pdf	Supplementary Document	Uploaded 2011-12-05	Available
16. Surgical Site Infection.pdf	Supplementary Document	Uploaded 2013-08-21	Available
12. MDRO & CDI.pdf	Supplementary Document	Uploaded 2013-08-21	Available
5. Central Line Insertion Practices Adherence.pdf	Supplementary Document	Uploaded 2013-08-21	Available
4. Central Line Associated Bloodstream Infection.pdf	Supplementary Document	Uploaded 2013-08-21	Available
3. Catheter Associated Urinary Tract Infection.pdf	Supplementary Document	Uploaded 2013-08-21	Available
13. Pneumonia (IC# 8).pdf	Supplementary Document	Uploaded 2012-10-15	Repair queued
6. Dialysis Event.pdf	Supplementary Document	Uploaded 2013-08-22	Available
4. Central Line-Associated Blood Stream Infection (IC# 5).pdf	Supplementary Document	Uploaded 2012-10-15	Available
14. Reporting Plan (IC# 1).pdf	Supplementary Document	Uploaded 2012-10-15	Available
0920-0666 Revision June 2013 Supporting Statement Part A.docx	Supporting Statement A	Uploaded 2013-08-28	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
7134	57.106 Patient Safety Monthly Reporting Plan	Form	Modified
208412	57.600 State Health Department Validation Record	Form	New
208411	57.506 Dialysis Patient Influenza Vaccination Denominator	Form	New
208410	57.505 Dialysis Patient Influenza Vaccination	Form	New
208409	57.504 Prevention Process Measures Monthly Monitoring for Dialysis	Form	New
208408	57.501 Dialysis Monthly Reporting Plan	Form	New
208407	57.403 Outpatient Procedure - Monthly Denominators and Summary	Form	New
208406	57.402 Outpatient Procedure - Event	Form	New
208405	57.401 Outpatient Procedure - Monthly Reporting Plan	Form	New
208404	57.400 Outpatient Procedure - Annual Facility Survey	Form	New
200382	57.151 Patient Safety Component -- Annual Facility Survey for IRF	Form	Modified
200381	57.150 Patient Safety Component -- Annual Facility Survey for LTAC	Form	Modified
200380	57.143 Prevention Process Measures Monthly Monitoring for LTCF	Form	Modified
200379	57.142 Denominators for LTCF Locations	Form	Modified
200378	57.141 Monthly Reporting Plan for LTCF	Form	Modified
200377	57.112 Ventilator-Associated Event (VAE)	Form	Modified
197543	57.139 MDRO and CDI Monthly Monitoring for LTCF	Form	Modified
197542	57.138 Laboratory-Identified MDRO or CDI Event for LTCF	Form	Modified
197541	57.137 Long Term care Facility Component--Annual Facility Survey	Form	Modified
190365	57.304 Hemovigilance Module Adverse Reaction	Form	Modified
190364	57.305 Hemovigilance Incident	Form	Modified
190363	57.303 Hemovigilance Module Monthly Reporting Denominators	Form	Modified
190362	57.302 Hemovigilance Module Monthly Incident Summary	Other-WORD	Removed
190361	57.301 Hemovigilance Module Monthly Reporting Plan	Form	Modified
190360	57.300 Hemovigilance Module Annual Facility Survey	Form	Modified
183582	57.200 Healthcare Personnel Safety Component Facility Survey	Form	Modified
183579	57.204 Healthcare Worker Demographic Data	Form	Modified
183578	57.206 Healthcare Worker Prophylaxis/Treatment	Form	Modified
183577	57.205 Exposure to Blood and Body Fluids	Form	Modified
183576	57.105 Group Contact Information	Form	Modified
183573	57.140 Urinary Tract Infection (UTI) for LTCF	Form	Modified
183572	57.103 Patient Safety Component - Annual Hospital Survey	Form	Modified
183571	57.131 Vaccination Monthly Monitoring Form - Patient-Level Method	Form	Modified
183570	57.101 Facility Contact Information	Form	Modified
183569	57.133 Patient Vaccination	Form	Modified
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	Form and Instruction	Modified
183567	57.130 Vaccination Monthly Monitoring Form - Summary Method	Form	Modified
183566	57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables	Form	Modified
183565	57.100 NHSN Registration Form	Form	Modified
183564	57.121 Denominators for Procedure	Form	Modified
183563	57.128 Laboratory Identified or CDI MDRO Event	Form	Modified
183562	57.120 Surgical Site Infection (SSI)	Form	Modified
183561	57.126 MDRO or CDI Infection Event	Form	Modified
183560	57.503 Denominators for Outpatient Dialysis	Form	Modified
183559	57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	Form	Modified
183558	57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA)	Form	Modified
183557	57.207 Follow-up Laboratory Testing	Form	Modified
183556	57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)	Form	Modified
183555	57.125 Central Line Insertion Practices Adherence Monitoring Form	Form	Modified
183554	57.116 Denominators for Neonatal Intensive Care Unit (NICU)	Form	Modified
183551	57.114 Urinary Tract Infection (UTI)	Form	Modified
183550	57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	Form	Modified
183549	57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	Form	Modified
183547	57.502 Dialysis Event	Form	Modified
183545	57.108 Primary Bloodstream Infection (BSI)	Form	Modified
183544	57.500 Outpatient Dialysis Center Practices Survey	Form	Modified
183543	57.203 Healthcare Personnel Safety Reporting Plan	Form	Modified

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 201308-0920-010
Status: Historical Active	Previous ICR Reference No: 201211-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 20352
Title: The National Healthcare Safety Network (NHSN)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/30/2013
	Date Received in OIRA: 08/28/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	36 Months From Approved	12/31/2015
Responses	8,810,700	0	4,905,350
Time Burden (Hours)	4,104,776	0	3,562,653
Cost Burden (Dollars)	138,604,613	0	20,165,365

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Abstract: 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. The data are 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,and to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. The NHSN has six components: Patient Safety, Healthcare Personnel Safety, Biovigilance,Long-Term Care Facility, Dialysis, and Outpatient Procedure.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 37224	06/20/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 52533	08/23/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 56

IC Title	Form No.	Form Name
57.112 Ventilator-Associated Event (VAE)	57.112	Ventilator-associated Event
57.141 Monthly Reporting Plan for LTCF	57.141	Monthly Reporting Plan for LTCF
57.142 Denominators for LTCF Locations	57.142	Denominators for LTCF Locations
57.143 Prevention Process Measures Monthly Monitoring for LTCF	57.143	Prevention Process Measures Monthly Monitoring
57.150 Patient Safety Component -- Annual Facility Survey for LTAC	57.150	LTAC Annual Survey
57.151 Patient Safety Component -- Annual Facility Survey for IRF	57.151	Rehab Annual Survey
57.400 Outpatient Procedure - Annual Facility Survey	57.400	Outpatient Procedure - Annual Facility Survey
57.401 Outpatient Procedure - Monthly Reporting Plan	57.401	Outpatient Procedure - Monthly Reporting Plan
57.402 Outpatient Procedure - Event	57.402	Outpatient Procedure - Event
57.403 Outpatient Procedure - Monthly Denominators and Summary	57.403	Outpatient Procedure - Monthly Denominators and Summary
57.501 Dialysis Monthly Reporting Plan	57.501	Dialysis Monthly Reporting Plan
57.504 Prevention Process Measures Monthly Monitoring for Dialysis	57.504	Prevention Process Measures Monthly Monitoring for Dialysis
57.505 Dialysis Patient Influenza Vaccination	57.505	Dialysis Patient Influenza Vaccination
57.506 Dialysis Patient Influenza Vaccination Denominator	57.506	Dialysis Patient Influenza Vaccination Denominator
57.600 State Health Department Validation Record	57.600	State Health Department Validation Record
57.302 Hemovigilance Module Monthly Incident Summary
57.106 Patient Safety Monthly Reporting Plan	57.106	Patient Safety Monthly Reporting Plan
57.203 Healthcare Personnel Safety Reporting Plan	57.203	Healthcare Personnel Safety Monthly Reporting Plan
57.500 Outpatient Dialysis Center Practices Survey	57.500	Outpatient Dialysis Center Practices Survey
57.108 Primary Bloodstream Infection (BSI)	57.108	Primary Bloodstream Infection
57.502 Dialysis Event	57.502	Dialysis Event
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	57.111	Pneumonia (PNEU)
57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	57.210	HCW Prophylaxis/Treatment-Influenza
57.114 Urinary Tract Infection (UTI)	57.114	Urinary Tract Infection
57.116 Denominators for Neonatal Intensive Care Unit (NICU)	57.116	Denominators for the Neonatal Intensive Care Unit
57.125 Central Line Insertion Practices Adherence Monitoring Form	57.125	Central Line Insertion Practices Adherence Monitoring
57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)	57.117	Denominators for Specialty Care Area
57.207 Follow-up Laboratory Testing	57.207	Follow-up Lab Testing
57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA)	57.118	Denominators for ICU
57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	57.127	MDRO and CDI Prevention Process and Outcome Measures Monitoring
57.503 Denominators for Outpatient Dialysis	57.503	Denominator for Outpatient Dialysis
57.126 MDRO or CDI Infection Event	57.126	MDRO or CDI Infection Event
57.120 Surgical Site Infection (SSI)	57.120	Surgical Site Infection
57.128 Laboratory Identified or CDI MDRO Event	57.128	Lab Identified MDRO or CDI Event
57.121 Denominators for Procedure	57.121	Denominator for Procedure
57.100 NHSN Registration Form	57.100	NHSN Registration
57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables	57.123	Antimicrobial Use and Resistance Micro Upload Tables
57.130 Vaccination Monthly Monitoring Form - Summary Method	57.130	Vaccination Monthly Monitoring - Summary Method
57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	57.124	Antimicrobial Use and Resistance - Pharm Data Upload Tables
57.133 Patient Vaccination	57.133	Patient Vaccination
57.101 Facility Contact Information	57.101	Facility Contact Information
57.131 Vaccination Monthly Monitoring Form - Patient-Level Method	57.131	Vaccination Monthly Monitoring - Patient level
57.103 Patient Safety Component - Annual Hospital Survey	57.103	Patient Safety - Annual Hospital Survey
57.140 Urinary Tract Infection (UTI) for LTCF	57.140	Urinary Tract Infection for LTCF
57.105 Group Contact Information	57.105	Group Contact Information
57.205 Exposure to Blood and Body Fluids	57.205	Exposure to Blood/Body Fluids
57.206 Healthcare Worker Prophylaxis/Treatment	57.206	Healthcare Worker Prophylaxis/Treatment
57.204 Healthcare Worker Demographic Data	57.204	Healthcare Worker Demographic Data
57.200 Healthcare Personnel Safety Component Facility Survey	57.200	Healthcare Personnel Safety - Annual Facility Survey
57.300 Hemovigilance Module Annual Facility Survey	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	57.303	Hemovigilance Module Monthly Reporting Denominators
57.305 Hemovigilance Incident	57.305	Hemovigilance Incident
57.304 Hemovigilance Module Adverse Reaction	57.304	Hemovigilance Adverse Reaction
57.137 Long Term care Facility Component--Annual Facility Survey	57.137	Long Term Care Facility - Annual Survey
57.138 Laboratory-Identified MDRO or CDI Event for LTCF	57.138	Lab-identified MDRO or CDI Event
57.139 MDRO and CDI Monthly Monitoring for LTCF	57.139	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF

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ICR Summary 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	8,810,700	4,905,350	0	3,905,350	0	0
Annual Time Burden (Hours)	4,104,776	3,562,653	0	542,123	0	0
Annual Cost Burden (Dollars)	138,604,613	20,165,365	0	118,439,248	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This ICR includes revision of 32 forms, the addition of 9 forms, and the removal of one form. It includes 2 new NHSN components - the Dialysis component changes 3 forms and adds 4 new ones. The Outpatient Procedure component add 4 forms. The breadth of organism susceptability data required on all healthcare-associated infection forms has been reduced. Changes were made to the Biovigilance component forms including removal of the monthly incident form. A new form will collect aggregate validation results by state health departments using the NHSN Validation Guidance and Toolkits.

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Annual Cost to Federal Government: $11,912,686

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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? Uncollected

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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: 08/28/2013

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