The National Healthcare Safety Network (NHSN)

Forms and Documents

Document Name	Status
Form CDC 57.106 57.106 Patient Safety Monthly Reporting Plan Form and Instruction	Modified
Form 57.507 57.507_HomeDialysisSurv_BLA Form	New
Form 57.320 57.320_HV AR-Other_BLANK Form	New
Form 57.319 57.319_HV AR-UNK_BLANK Form	New
Form 57.318 57.318_HV AR-TACO_BLANK Form	New
Form 57.317 57.317_HV AR-TRALI_BLAN Form	New
Form 57.316 57.316_HV AR-TAGVHD_BLAN Form	New
Form 57.315 57.315_HV AR-TAD_BLAN Form	New
Form 57.314 57.314_HV AR-PTP_BLAN Form	New
Form 57.313 57.313_HV AR-Infection_BLAN Form	New
Form 57.312 57.312_HV AR-HTR_BLANK Form	New
Form 57.311 57.311_HV AR-FNHTR_BLANK Form	New
Form 57.310 57.310_HV AR-DSTR_BLANK Form	New
Form 57.309 57.309_HV AR-DHTR_BLANK Form	New
Form 57.308 57.308_HV AR-Allergic_BLANK Form	New
Form 57.307 57.307_HV AR-AHTR_BLANK Form	New
Form 57.306 57.306_HV Annual Facility Sur Form	New
Form 57.129 57.129_Adult Sepsis_BLANK Form	New
Form 57.115 57.115_CUS_BLANK Form	New
Form 57.113 57.113 Pediatric Ventilator-Associated Event (PedVAE) Form	New
Form CDC 57.506 57.506 Dialysis Patient Influenza Vaccination Denominator Form	Modified
Form CDC 57.505 57.505 Dialysis Patient Influenza Vaccination Form	Modified
Form CDC 57.504 57.504 Prevention Process Measures Monthly Monitoring for Dialysis Form	Modified
Form CDC 57.501 57.501 Dialysis Monthly Reporting Plan Form	Modified
Form CDC 57.403 57.403 Outpatient Procedure - Monthly Denominators and Summary Form	Modified
Form CDC 57.402 57.402 Outpatient Procedure - Event Form	Modified
Form CDC 57.401 57.401 Outpatient Procedure - Monthly Reporting Plan Form	Modified
Form CDC 57.400 57.400 Outpatient Procedure - Annual Facility Survey Form	Modified
Form CDC 57.151 57.151 Patient Safety Component -- Annual Facility Survey for IRF Form	Modified
Form CDC 57.150 57.150 Patient Safety Component -- Annual Facility Survey for LTAC Form	Modified
Form CDC 57.143 57.143 Prevention Process Measures Monthly Monitoring for LTCF Form	Modified
Form CDC 57.142 57.142 Denominators for LTCF Locations Form	Modified
Form CDC 57.141 57.141 Monthly Reporting Plan for LTCF Form	Modified
Form CDC 57.112 57.112 Ventilator-Associated Event (VAE) Form	Modified
Form CDC 57.139 57.139 MDRO and CDI LabID Event Reporting Monthly Summary Data for LTCF Form	Modified
Form CDC 57.138 57.138 Laboratory-Identified MDRO or CDI Event for LTCF Form	Modified
Form CDC 57.137 57.137 Long Term care Facility Component--Annual Facility Survey Form	Modified
Form CDC 57.304 57.304 Hemovigilance Module Adverse Reaction Form	Removed
Form CDC 57.305 57.305 Hemovigilance Incident Form	Modified
Form CDC 57.303 57.303 Hemovigilance Module Monthly Reporting Denominators Form	Modified
Form CDC 57.301 57.301 Hemovigilance Module Monthly Reporting Plan Form	Modified
Form CDC 57.300 57.300 Hemovigilance Module Annual Survey -- Acute Care Facility Form	Modified
Form CDC 57.200 57.200 Healthcare Personnel Safety Component Facility Survey Form	Modified
Form CDC 57.204 57.204 Healthcare Worker Demographic Data Form	Modified
Form CDC 57.206 57.206 Healthcare Worker Prophylaxis/Treatment Form	Modified
Form CDC 57.205 57.205 Exposure to Blood and Body Fluids Form	Modified
Form CDC 57.105 57.105 Group Contact Information Form	Modified
Form CDC 57.140 57.140 Urinary Tract Infection (UTI) for LTCF Form	Modified
Form CDC 57.103 57.103 Patient Safety Component - Annual Hospital Survey Form	Modified
Form CDC 57.101 57.101 Facility Contact Information Form	Modified
Form CDC 57.124 57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data Form	Modified
Form CDC 57.123 57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables Form	Modified
Form CDC 57.100 57.100 NHSN Registration Form Form	Modified
Form CDC 57.121 57.121 Denominators for Procedure Form	Modified
Form CDC 57.128 57.128 Laboratory Identified or CDI MDRO Event Form	Modified
Form CDC 57.120 57.120 Surgical Site Infection (SSI) Form	Modified
Form CDC 57.126 57.126 MDRO or CDI Infection Event Form	Modified
Form CDC 57.503 57.503 Denominators for Outpatient Dialysis Form	Modified
Form CDC 57.127 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Form	Modified
Form CDC 57.118 57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA) Form	Modified
Form CDC 57.207 57.207 Follow-up Laboratory Testing Form	Modified
Form CDC 57.117 57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC) Form	Modified
Form CDC 57.125 57.125 Central Line Insertion Practices Adherence Monitoring Form Form	Modified
Form CDC 57.116 57.116 Denominators for Neonatal Intensive Care Unit (NICU) Form	Modified
Form CDC 57.114 57.114 Urinary Tract Infection (UTI) Form	Modified
Form CDC 57.210 57.210 Healthcare Worker Prophylaxis/Treatment - Influenza Form	Modified
Form CDC 57.111 57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) Form	Modified
Form CDC 57.502 57.502 Dialysis Event Form	Modified
Form CDC 57.108 57.108 Primary Bloodstream Infection (BSI) Form	Modified
Form CDC 57.500 57.500 Outpatient Dialysis Center Practices Survey Form and Instruction	Modified
Form CDC 57.203 57.203 Healthcare Personnel Safety Reporting Plan Form	Modified
Att H3_NHSN 308d Request for Extension and Amendment.docx Supplementary Document	2015-09-09
H2. NHSN 308d Request for Extension and Ammendment.docx Supplementary Document	2016-08-09
Att H1_NHSN 308d Approval 2010.pdf Supplementary Document	2015-09-09
Att F2_NHSN - Report of End of Human Research Review 0.1253.docx Supplementary Document	2015-09-08
Att F1_Closure of Protocol.msg Supplementary Document	2015-09-08
E6. Inpatient Psychiatric Facilities- FLU_FRN.pdf Supplementary Document	2016-08-09
E5. Ambulatory Surgery Centers & Outpatient ACF Departments_FRN.pdf Supplementary Document	2016-08-09
E4. Dialysis Facilities - Dialysis Event, FLU_FRN.pdf Supplementary Document	2016-08-09
E3. Inpatient Rehabilitation Facility_FRN.pdf Supplementary Document	2016-08-09
E2. Acute Care Facilitie, Long-Term Acute Care Facilities, oOncology Hospitals_FRN.pdf Supplementary Document	2016-08-09
E1. NHSN Forms used for CMS QRPs & State Mandated Reporting.docx Supplementary Document	2016-08-08
D4. Revision of Estimated Annual Cost Burden_rev1.docx Supplementary Document	2016-08-12
D3. Revision of Estimated Annual Burden Hours_rev1.docx Supplementary Document	2016-08-12
D2. Itemized IC Revisions and Justifications.docx Supplementary Document	2016-08-08
D1. Explanations and justifications for proposed revisions to OMB 0920-0666.docx Supplementary Document	2016-08-08
B. 60 Day Federal Register Notice.pdf Supplementary Document	2016-08-08
SupSta Part B_ Rev.0516_0920-0666.docx Supporting Statement B	2016-08-08
3. 42 USC 242m.pdf Supplementary Document	2013-08-21
2. 42 USC 242k.pdf Supplementary Document	2013-08-21
1. 42 USC 242b.pdf Supplementary Document	2013-08-21
0920-0666_ Sup Sta A_rev3_0816 OMB comments2_DHQPv2.docx Supporting Statement A	2016-11-22

IC Document Collections

IC ID	Document Title	Status
7134	57.106 Patient Safety Monthly Reporting Plan Form and Instruction	Modified
222908	57.507_HomeDialysisSurv_BLA Form	New
222907	57.320_HV AR-Other_BLANK Form	New
222906	57.319_HV AR-UNK_BLANK Form	New
222905	57.318_HV AR-TACO_BLANK Form	New
222904	57.317_HV AR-TRALI_BLAN Form	New
222903	57.316_HV AR-TAGVHD_BLAN Form	New
222902	57.315_HV AR-TAD_BLAN Form	New
222901	57.314_HV AR-PTP_BLAN Form	New
222900	57.313_HV AR-Infection_BLAN Form	New
222899	57.312_HV AR-HTR_BLANK Form	New
222898	57.311_HV AR-FNHTR_BLANK Form	New
222897	57.310_HV AR-DSTR_BLANK Form	New
222896	57.309_HV AR-DHTR_BLANK Form	New
222895	57.308_HV AR-Allergic_BLANK Form	New
222894	57.307_HV AR-AHTR_BLANK Form	New
222893	57.306_HV Annual Facility Sur Form	New
222892	57.129_Adult Sepsis_BLANK Form	New
222891	57.115_CUS_BLANK Form	New
222890	57.113 Pediatric Ventilator-Associated Event (PedVAE) Form	New
208411	57.506 Dialysis Patient Influenza Vaccination Denominator Form	Modified
208410	57.505 Dialysis Patient Influenza Vaccination Form	Modified
208409	57.504 Prevention Process Measures Monthly Monitoring for Dialysis Form	Modified
208408	57.501 Dialysis Monthly Reporting Plan Form	Modified
208407	57.403 Outpatient Procedure - Monthly Denominators and Summary Form	Modified
208406	57.402 Outpatient Procedure - Event Form	Modified
208405	57.401 Outpatient Procedure - Monthly Reporting Plan Form	Modified
208404	57.400 Outpatient Procedure - Annual Facility Survey Form	Modified
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 LabID Event Reporting Monthly Summary Data 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	Removed
190364	57.305 Hemovigilance Incident Form	Modified
190363	57.303 Hemovigilance Module Monthly Reporting Denominators Form	Modified
190361	57.301 Hemovigilance Module Monthly Reporting Plan Form	Modified
190360	57.300 Hemovigilance Module Annual Survey -- Acute Care Facility 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
183570	57.101 Facility Contact Information Form	Modified
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data 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 and Instruction	Modified
183543	57.203 Healthcare Personnel Safety Reporting Plan Form	Modified

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 201607-0920-013
Status: Historical Active	Previous ICR Reference No: 201603-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0666
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 with change	Conclusion Date: 11/22/2016
	Date Received in OIRA: 08/17/2016
Terms of Clearance: CDC is approved to proceed with this collection and will coordinate future amendments to the collection instruments with CMS and other agencies/groups that require mandatory reporting of NHSN-collected data.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved	12/31/2018
Responses	9,440,900	0	9,007,950
Time Burden (Hours)	5,110,966	0	4,622,542
Cost Burden (Dollars)	146,700,713	0	146,685,095

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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.

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

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:
	81 FR 34337	05/31/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 52434	08/08/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 70

IC Title	Form No.	Form Name
57.106 Patient Safety Monthly Reporting Plan	CDC 57.106	Patient Safety Monthly Reporting Plan
57.203 Healthcare Personnel Safety Reporting Plan	CDC 57.203	Healthcare Personnel Safety Monthly Reporting Plan
57.500 Outpatient Dialysis Center Practices Survey	CDC 57.500	Outpatient Dialysis Center Practices Survey
57.108 Primary Bloodstream Infection (BSI)	CDC 57.108	Primary Bloodstreat Infection (BSI)
57.502 Dialysis Event	CDC 57.502	Dialysis Event
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	CDC 57.111	Pneumonia (PNEU)
57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	CDC 57.210	HCW Prophylaxis/Treatment-Influenza
57.307_HV AR-AHTR_BLANK	57.307	Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction
57.313_HV AR-Infection_BLAN	57.313	Hemovigilance Adverse Reaction - Infection
57.318_HV AR-TACO_BLANK	57.318	Hemoviligance Adverse Reaction - Transfusion Associated Circulatory Overload
57.319_HV AR-UNK_BLANK	57.319	Hemovigilance Adverse Reaction - Unknown Transfusion Reaction
57.507_HomeDialysisSurv_BLA	57.507	Home Dialysis Center Practices Survey
57.129_Adult Sepsis_BLANK	57.129	Adult Sepsis_
57.114 Urinary Tract Infection (UTI)	CDC 57.114	Urinary Tract infection (UTI)
57.116 Denominators for Neonatal Intensive Care Unit (NICU)	CDC 57.116	Denominators for Neonatal intensive Care Unit (NICU)
57.125 Central Line Insertion Practices Adherence Monitoring Form	CDC 57.125	Central Line Insertion Practices Adherence Monitoring
57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)	CDC 57.117	Denominators for Specialty Care Area (SCA) Oncology (ONC)
57.207 Follow-up Laboratory Testing	CDC 57.207	Follow-up Laboratory Testing
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)
57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	CDC 57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Reporting
57.503 Denominators for Outpatient Dialysis	CDC 57.503	Demominators for Dialysis Event Surveillance
57.126 MDRO or CDI Infection Event	CDC 57.126	MDRO or CDI Infection Event
57.120 Surgical Site Infection (SSI)	CDC 57.120	Surgical Site Infection (SSI)
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
57.121 Denominators for Procedure	CDC 57.121	Denominatoir for Procedure
57.100 NHSN Registration Form	CDC 57.100	NHSN Registration Form
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	CDC 57.124	Antimicrobial Use and Resistance (AUR): Pharmacy Date Monthly Electronice Upload Specification Tables
57.101 Facility Contact Information	CDC 57.101	Facility Contact Information
57.103 Patient Safety Component - Annual Hospital Survey	CDC 57.103	Patient Safety Component-Annual Hospital Survey
57.140 Urinary Tract Infection (UTI) for LTCF	CDC 57.140	Urinary Tract Infection (UTI) for LTCF
57.105 Group Contact Information	CDC 57.105	Group Contact Information
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
57.204 Healthcare Worker Demographic Data	CDC 57.204	Healthcare Worker Demographic Data
57.200 Healthcare Personnel Safety Component Facility Survey	CDC 57.200	Healthcare Personnel Safety - Annual Facility Survey
57.300 Hemovigilance Module Annual Survey -- Acute Care Facility	CDC 57.300	Hemovigilance Module - Annual Facility Survey -- Acute Care Facility
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
57.320_HV AR-Other_BLANK	57.320	Hemovigilance Adverse Reaction - Other Transfusion Reaction
57.305 Hemovigilance Incident	CDC 57.305	Hemovigilance Module Incident
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 LabID Event Reporting Monthly Summary Data for LTCF	CDC 57.139	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
57.112 Ventilator-Associated Event (VAE)	CDC 57.112	Ventilator-Associated Event (VAE)
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 Faciity Survey for LTAC
57.151 Patient Safety Component -- Annual Facility Survey for IRF	CDC 57.151	Rehab Annual Survey
57.400 Outpatient Procedure - Annual Facility Survey	CDC 57.400	Patient Safety Component---Annual Facility Survey for Ambulatory Surgery Center (ASC)
57.402 Outpatient Procedure - Event	CDC 57.402	Outpatient Procedure - Event
57.403 Outpatient Procedure - Monthly Denominators and Summary	CDC 57.403	Outpatient Procedure - Monthly Denominators and Summary
57.401 Outpatient Procedure - Monthly Reporting Plan	CDC 57.401	Outpatient Procedure Component Monthly Reporting Plan
57.501 Dialysis Monthly Reporting Plan	CDC 57.501	NHSN Registration Form
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
57.113 Pediatric Ventilator-Associated Event (PedVAE)	57.113	Pediatric Ventilator-Associated Event (PedVAE)
57.115_CUS_BLANK	57.115	Custom Event
57.310_HV AR-DSTR_BLANK	57.310	Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction
57.312_HV AR-HTR_BLANK	57.312	Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction
57.314_HV AR-PTP_BLAN	57.314	Hwemovilgilance Adverse Reaction - Post Transfusion Purpura
57.316_HV AR-TAGVHD_BLAN	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
57.304 Hemovigilance Module Adverse Reaction	CDC 57.304	Hemovigilance Module Adverse Reaction
57.306_HV Annual Facility Sur	57.306	Hemovigilance Module Annual Survey - Non-acute Care Facility
57.309_HV AR-DHTR_BLANK	57.309	Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction
57.311_HV AR-FNHTR_BLANK	57.311	Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction
57.308_HV AR-Allergic_BLANK	57.308	Hemovigilance Adverse Reaction - Allergic Transfusion Reaction
57.315_HV AR-TAD_BLAN	57.315	Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea

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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	9,440,900	9,007,950	0	432,950	0	0
Annual Time Burden (Hours)	5,110,966	4,622,542	0	488,424	0	0
Annual Cost Burden (Dollars)	146,700,713	146,685,095	0	15,618	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: Changing Forms

Short Statement: Twenty-two previously approved forms were updated based on user feedback and clarifications in surveillance definitions. Nineteen new forms were added and one form was removed.

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Annual Cost to Federal Government: $13,786,099

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: 08/17/2016

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