[NCEZID] National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) Surveillance in Healthcare Facilities

Forms and Documents

Document Name	Status
Form 57.510 57.510 COVID–19 Module Dialysis Outpatient Facility-CSV Form and Instruction	New
Form 57.509 57.509 Weekly Patient COVID-19 Vaccination Cumulative Summary for Dialysis Facilities-.CSV Form and Instruction	New
Form 57.221 57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_CSV Form and Instruction	New
Form 57.221 57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_Manual Form and Instruction	New
Form 57.221 57.221 Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component_CSV Form and Instruction	New
Form 57.221 57.221 Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component _Manual Form and Instruction	New
Form 57.220 57.220 Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_CSV Form and Instruction	New
Form 57.220 57.220 Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_Manual Form and Instruction	New
Form 57.155 57.155 Point of Care Testing Results - CSV Form and Instruction	New
Form 57.219 Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary (.csv) Form and Instruction	Unchanged
Form 57.218 Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities (.csv) Form and Instruction	Unchanged
Form 57.217 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (.csv) Form and Instruction	Modified
Form 57.217 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (manual) Form and Instruction	Modified
Form 57.216 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (.csv) Form and Instruction	Modified
Form 57.216 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (manual) Form and Instruction	Modified
Form 57.102 57.102 - Hospital Respiratory Data Fomr (Daily - API) Form and Instruction	Unchanged
Form 57.102 57.102 Hospital Respiratory Data Form (Daily - .csv import) Form and Instruction	Unchanged
Form 57.102 57.102 - Hospital Respiratory Data Form (Daily - user entry) Form and Instruction	Unchanged
Form 0920-1317 57.101 Hospital Respiratory Data Form (Weekly - API) Form and Instruction	Unchanged
Form 0920-1317 57.101 Hospital Respiratory Data Form (Weekly - .csv import) Form and Instruction	Unchanged
Form 0920-1317 57.101 Hospital Respiratory Data Form (Weekly - User Entry) Form and Instruction	Unchanged
Form 57.155 57.155 Point of Care Testing Results - Manual Form and Instruction	Modified
NHSN COVID-19 Hospital Module (Infusion Centers and Outpatient Clinics reporting Inventory & use of therapeutics (MABs) Form and Instruction	Removed
Form CDC Form 57.203 Healthcare Personnel Safety Monthly Reporting Plan - completed by Inpatient Psychiatric Facilities Form and Instruction	Removed
Form CDC Form 57.203 Healthcare Personnel Safety Monthly Reporting Plan - completed by Dialysis Facilities Form and Instruction	Removed
Form CDC Form 57.141 Monthly Reporting Plan form for Long-term Care Facilities Form and Instruction	Removed
Form 57.509 57.509 Weekly Patient COVID-19 Vaccination Cumulative Summary for Dialysis Facilities_Manual Form and Instruction	Modified
Form 57.218 Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities (manual) Form and Instruction	Unchanged
Form 57.219 Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary (manual) Form and Instruction	Unchanged
Form 0920-1317 VA - Staff and Personnel COVID-19 Event Form - LTCF Form and Instruction	Removed
Form 0920-1317 VA - Resident COVID-19 Event Form - LTCF Form and Instruction	Removed
Form 57.510 57.510 COVID–19 Module Dialysis Outpatient Facility_Manual Form and Instruction	Modified
Form CDC 57.145 Staff and Personnel Impact - State and Local Health Dept Occupations retrospective Form and Instruction	Removed
Form CDC 57.145 Staff and Personnel Impact - Business and Financial Operations Occupations retrospective Form and Instruction	Removed
Form CDC 57.145 Staff and Personnel Impact - LTCF Personnel retrospective Form and Instruction	Removed
Form CDC 57.145 Staff and Personnel Impact - State and Local Health Dept Occupations Form and Instruction	Removed
Form CDC 57.145 Staff and Personnel Impact - Business and Financial Operations Occupations Form and Instruction	Removed
Form CDC 57.145 Staff and Personnel Impact - LTCF Personnel Form and Instruction	Removed
Form CDC 57.144 Long Term Care Facility Resident Impact and Facility Capacity Pathway Form and Instruction	Removed
Form 0920-1317 57.140 NHSN and Secure Access Management Services (SAMS) enrollment Form and Instruction	Modified
D. Explanation for Program Changes or Adjustments.docx Supplementary Document	2024-10-29
G2. Privacy Impact Assessment.pdf Supplementary Document	2024-10-29
G1. Privacy Impact Assessment.pdf Supplementary Document	2024-10-29
G. Privacy Impact Assessment.pdf Supplementary Document	2024-10-29
E3. Human Subjects Determination.pdf Supplementary Document	2024-10-29
B. FRN-60 day.pdf Supplementary Document	2024-10-29
SSB 0920-1317 NHSN COVID-19_FINAL.docx Supporting Statement B	2024-10-29
SSA 0920-1317 NHSN COVID-19_FINAL.docx Supporting Statement A	2024-10-29
Change Memo 0920-1317 August 2024_FINAL_v2.docx Justification for No Material/Nonsubstantive Change	2024-08-22
Change Memo 0920-1317.docx Justification for No Material/Nonsubstantive Change	2024-08-06
Change Request Memo NHSN COVID-19 0920-1317_26APR2024 v2.docx Justification for No Material/Nonsubstantive Change	2024-04-26
Change Memo for CDC NHSN COVID-19 OMB Package 0920-1317.docx Justification for No Material/Nonsubstantive Change	2024-03-14
Resident Impact and Facility Capacity- csv temp..csv Supplementary Document	2023-09-07
TOI-Facility Importing COVID-19 and Respiratory Infections using a .csv file_RIFC.docx Supplementary Document	2023-09-07
Change Memo for NHSN September 2023_0920_1317.docx Justification for No Material/Nonsubstantive Change	2023-09-07
Crosswalk_57.218.docx Supplementary Document	2023-09-07
Crosswalk_57.144.docx Supplementary Document	2023-09-07
Crosswalk-COVID-19 Hospital Data.docx Supplementary Document	2023-09-07
Crosswalk 11.4 updated COVID JUNE_final.docx Supplementary Document	2023-05-18
Change Memo for NHSN May 2023_0920_1317_final.docx Justification for No Material/Nonsubstantive Change	2023-05-18
CDC Response to APIC Dec29 letter sk lw.docx Supplementary Document	2023-03-06
5. NHSN - Report of End of Human Research Review 0.1253.docx Supplementary Document	2022-11-28
6. IRB Protocol Closure.pdf Supplementary Document	2022-11-28
3. Privacy Act Checklist 2022.docx Supplementary Document	2022-11-28
1c. 42 USC 242m.PDF Supplementary Document	2022-11-28
1b. 42 USC 242k.PDF Supplementary Document	2022-11-28
1a. 42 USC 242b.PDF Supplementary Document	2022-11-28

IC Document Collections

IC ID	Document Title	Status
271955	57.510 COVID–19 Module Dialysis Outpatient Facility-CSV Form and Instruction	New
271950	57.509 Weekly Patient COVID-19 Vaccination Cumulative Summary for Dialysis Facilities-.CSV Form and Instruction	New
271948	57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_CSV Form and Instruction	New
271947	57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_Manual Form and Instruction	New
271946	57.221 Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component_CSV Form and Instruction	New
271945	57.221 Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component _Manual Form and Instruction	New
271943	57.220 Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_CSV Form and Instruction	New
271941	57.220 Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_Manual Form and Instruction	New
271935	57.155 Point of Care Testing Results - CSV Form and Instruction	New
270333	Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary (.csv) Form and Instruction	Unchanged
270316	Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities (.csv) Form and Instruction	Unchanged
270313	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (.csv) Form and Instruction	Modified
270312	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (manual) Form and Instruction	Modified
270310	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (.csv) Form and Instruction	Modified
270309	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (manual) Form and Instruction	Modified
269868	57.102 - Hospital Respiratory Data Fomr (Daily - API) Form and Instruction	Unchanged
269867	57.102 Hospital Respiratory Data Form (Daily - .csv import) Form and Instruction	Unchanged
269866	57.102 - Hospital Respiratory Data Form (Daily - user entry) Form and Instruction	Unchanged
269865	57.101 Hospital Respiratory Data Form (Weekly - API) Form and Instruction	Unchanged
269864	57.101 Hospital Respiratory Data Form (Weekly - .csv import) Form and Instruction	Unchanged
269863	57.101 Hospital Respiratory Data Form (Weekly - User Entry) Form and Instruction	Unchanged
266012	57.155 Point of Care Testing Results - Manual Form and Instruction	Modified
257194	NHSN COVID-19 Hospital Module (Infusion Centers and Outpatient Clinics reporting Inventory & use of therapeutics (MABs) Form and Instruction	Removed
249439	Healthcare Personnel Safety Monthly Reporting Plan - completed by Inpatient Psychiatric Facilities Form and Instruction	Removed
249438	Healthcare Personnel Safety Monthly Reporting Plan - completed by Dialysis Facilities Form and Instruction	Removed
249437	Monthly Reporting Plan form for Long-term Care Facilities Form and Instruction	Removed
249436	57.509 Weekly Patient COVID-19 Vaccination Cumulative Summary for Dialysis Facilities_Manual Form and Instruction	Modified
249435	Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities (manual) Form and Instruction	Unchanged
249434	Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary (manual) Form and Instruction	Unchanged
247669	VA - Staff and Personnel COVID-19 Event Form - LTCF Form and Instruction	Removed
247668	VA - Resident COVID-19 Event Form - LTCF Form and Instruction	Removed
243719	57.510 COVID–19 Module Dialysis Outpatient Facility_Manual Form and Instruction	Modified
243711	Staff and Personnel Impact - State and Local Health Dept Occupations retrospective Form and Instruction	Removed
243710	Staff and Personnel Impact - Business and Financial Operations Occupations retrospective Form and Instruction	Removed
243709	Staff and Personnel Impact - LTCF Personnel retrospective Form and Instruction	Removed
243708	Staff and Personnel Impact - State and Local Health Dept Occupations Form and Instruction	Removed
243707	Staff and Personnel Impact - Business and Financial Operations Occupations Form and Instruction	Removed
243706	Staff and Personnel Impact - LTCF Personnel Form and Instruction	Removed
243702	Long Term Care Facility Resident Impact and Facility Capacity Pathway Form and Instruction	Removed
243698	57.140 NHSN and Secure Access Management Services (SAMS) enrollment Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1317	ICR Reference No: 202410-0920-012
Status: Received in OIRA	Previous ICR Reference No: 202408-0920-011
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1317
Title: [NCEZID] National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) Surveillance in Healthcare Facilities
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/30/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2026
Responses	3,653,433	6,086,324
Time Burden (Hours)	1,752,540	2,766,084
Cost Burden (Dollars)	0	0

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Abstract: The goal of this information collection is to 1) capture the daily, aggregate impact of COVID-19 on healthcare facilities, and 2) monitor medical capacity to respond at local, state, and national levels. This information will be used to inform the overall real-time COVID-19 response efforts and possible resource allocation, and enable state and local health departments to gain immediate access to the COVID-19 data for healthcare facilities within their jurisdiction. This Revision ICR is submitted to add 2 new data collection forms and make modifications/revisions to 10 currently approved data collection instruments and remove 13 instruments that are being retired from the package. . There is a net decrease in burden.to 1,752,540 hours.

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Authorizing Statute(s): US Code: 42 USC 242b, k, m Name of Law: U.S. Public Health Service Act (PHSA)
  

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:
	89 FR 47962	06/04/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 84146	10/21/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
57.101 Hospital Respiratory Data Form (Weekly - .csv import)	0920-1317	Hospital Respiratory Data Weekly Reporting Form
57.101 Hospital Respiratory Data Form (Weekly - API)	0920-1317	Hospital Respiratory Data Weekly Reporting Form
57.101 Hospital Respiratory Data Form (Weekly - User Entry)	0920-1317	Hospital Respiratory Data Weekly Reporting Form
57.102 - Hospital Respiratory Data Fomr (Daily - API)	57.102	Hospital Respiratory Data Daily Reporting Form 14AUG2024
57.102 - Hospital Respiratory Data Form (Daily - user entry)	57.102	Hospital Respiratory Data Daily Reporting Form 14AUG2024
57.102 Hospital Respiratory Data Form (Daily - .csv import)	57.102	Hospital Respiratory Data Daily Reporting Form 14AUG2024
57.140 NHSN and Secure Access Management Services (SAMS) enrollment	0920-1317	NHSN Registration Form
57.155 Point of Care Testing Results - CSV	57.155	Point of Care Testing Results
57.155 Point of Care Testing Results - Manual	57.155	Point of Care Testing Results
57.220 Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_CSV	57.220	Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_CSV
57.220 Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_Manual	57.220	Weekly Person Level Respiratory Pathogen and Vaccination for Residents-LTCF Component_Manual
57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_CSV	57.221	57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_CSV
57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_Manual	57.221	57.221 Healthcare Personnel COVID-19 Person Level Vaccination-Healthcare Personnel Safety Component_Manual
57.221 Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component _Manual	57.221	Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component_Manual
57.221 Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component_CSV	57.221	Healthcare Personnel COVID-19 Person Level Vaccination-LTC Component_CSV
57.509 Weekly Patient COVID-19 Vaccination Cumulative Summary for Dialysis Facilities-.CSV	57.509	57.509 Weekly COVID-19 Vaccination Cumulative Summary for Dialysis Patients_CSV
57.509 Weekly Patient COVID-19 Vaccination Cumulative Summary for Dialysis Facilities_Manual	57.509	Weekly COVID-19 Vaccination Cumulative Summary for Dialysis Patients_Manual
57.510 COVID–19 Module Dialysis Outpatient Facility-CSV	57.510	57.510 COVID–19 Module Dialysis Outpatient Facility-.csv
57.510 COVID–19 Module Dialysis Outpatient Facility_Manual	57.510	COVID–19 Module - Dialysis Outpatient Facility
Healthcare Personnel Safety Monthly Reporting Plan - completed by Dialysis Facilities	CDC Form 57.203	Healthcare Personnel Safety Monthly Reporting Plan
Healthcare Personnel Safety Monthly Reporting Plan - completed by Inpatient Psychiatric Facilities	CDC Form 57.203	Healthcare Personnel Safety Monthly Reporting Plan
Long Term Care Facility Resident Impact and Facility Capacity Pathway	57.144, CDC 57.144	Resident Impact and Facility Capacity ,   COVID-19 and Respiratory Infections Module Long Term Care Facility Resident Impact and Facility Capacity Pathway Form (57.144) 07SEP2023
Monthly Reporting Plan form for Long-term Care Facilities	CDC Form 57.141	Monthly Reporting Plan for LTCF
NHSN COVID-19 Hospital Module (Infusion Centers and Outpatient Clinics reporting Inventory & use of therapeutics (MABs)	n/a	NHSN COVID-19 Hospital Module Infusion Centers and Outpatient Clinics
Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (.csv)	57.217	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel
Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (manual)	57.217	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel
Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (.csv)	57.216	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents
Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (manual)	57.216	Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents
Staff and Personnel Impact - Business and Financial Operations Occupations	CDC 57.145	Staff and Personnel Impact
Staff and Personnel Impact - Business and Financial Operations Occupations retrospective	CDC 57.145	Staff and Personnel Impact
Staff and Personnel Impact - LTCF Personnel	CDC 57.145	Staff and Personnel Impact
Staff and Personnel Impact - LTCF Personnel retrospective	CDC 57.145	Staff and Personnel Impact
Staff and Personnel Impact - State and Local Health Dept Occupations	CDC 57.145	Staff and Personnel Impact
Staff and Personnel Impact - State and Local Health Dept Occupations retrospective	CDC 57.145	Staff and Personnel Impact
VA - Resident COVID-19 Event Form - LTCF	0920-1317	VA COVID-19 Resident Event Form
VA - Staff and Personnel COVID-19 Event Form - LTCF	0920-1317	VA - Staff and Personnel COVID-19 Event Form
Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary (.csv)	57.219	Healthcare Personnel COVID-19 Vaccination Cumulative Summary
Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary (manual)	57.219	Healthcare Personnel COVID-19 Vaccination Cumulative Summary
Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities (.csv)	57.218	Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities
Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities (manual)	57.218	Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities

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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	3,653,433	6,086,324	0	-2,432,891	0	0
Annual Time Burden (Hours)	1,752,540	2,766,084	0	-1,013,544	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Revision of OMB Control No. 0920-1317 is submitted to add 2 new data collection forms and make modifications/revisions to 10 currently approved data collection instruments and remove 13 instruments that are being retired from the package. There is a net decrease in burden.to 1,752,540 hours.

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Annual Cost to Federal Government: $49,992,135

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.     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? 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: 10/30/2024

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