[NCEZID] Phased Approach to the Resumption of Cruise Ship Passenger Operations

Forms and Documents

Document Name	Status
Form 0920-1335 Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (submitted sooner than 24 hours before arrival in U.S because 3% or more of the voyage's passengers or crew have ARI) Form	New
Form 0920-1335 COVID-19 Program for Cruise Ships Notice of Participation/Nonparticipation Form	Unchanged
Form 0920-1335 Cruise Ship Vaccination Status Classification Form	Unchanged
Form 0920-1335 Cruise Ship Physician - COVID-19 Contact Investigation Worksheet (if necessary) Form	Unchanged
Form 0920-1335 Cruise Ship Physician - COVID-19 Case Investigation Worksheet (if necessary) Form	Unchanged
Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form (submitted once per voyage, within 24 hours before arrival in U.S.) Form	Modified
0920-1335 Change Justification_2023 10 23_clean.docx Justification for No Material/Nonsubstantive Change	2023-10-27
0920-1335 Change Justification_6.6.2023.docx Supplementary Document	2023-06-06
Non-Sub Change 0920-1335 EDC Update-Final_3.7.23.docx Justification for No Material/Nonsubstantive Change	2023-03-08
Attachment J_Maritime Conveyance Illness or Death Investigation Form.pdf Supplementary Document	2022-03-15
Attachment I_Maritime Conveyance Cumulative Influenza_Influenza-Like Illness (ILI) Form.pdf Supplementary Document	2022-03-15
Attachment R_CSO Partner Survey.docx Supplementary Document	2022-03-15
Attachment S_Not Research Determination.pdf Supplementary Document	2022-03-15
Attachment G_COVID19 Response Plan.docx Supplementary Document	2022-03-15
Attachment F_Cruise Ship Vaccination Status Classification.docx Supplementary Document	2022-03-15
Attachment E_Notice of Participation-Nonparticipation.docx Supplementary Document	2022-03-15
Attachment D_Temporary Extension and Modification of Framework for Conditional Sailing Order.pdf Supplementary Document	2022-03-15
Attachment C_Framework for Conditional Sailing Order 11.4.2020.pdf Supplementary Document	2022-03-15
Attachment B_60-Day FRN 4.30.2021.pdf Supplementary Document	2022-03-15
Attachment A3_42 CFR part 71.docx Supplementary Document	2022-03-15
Attachment A2_42 CFR 70.docx Supplementary Document	2022-03-15
Attachment A1_Public Health Service (PHS) Act (42 USC 264).pdf Supplementary Document	2022-03-15
Emergency Review Request Memo - CSO Extension 10.27.21.pdf Supplementary Document	2021-10-27
Attachment BB_Not Research Determination.pdf Supplementary Document	2021-10-27
Attachment D_Response to Public Comment.docx Supplementary Document	2021-10-27
Attachment C_Public Comments.pdf Supplementary Document	2021-10-27
60d FRN published.pdf Supplementary Document	2021-10-27
Attachment E_CSO-Extension.pdf Supplementary Document	2021-10-27
Suporting Statement B_0920-1335_CDC COVID19 Program for Cruise Ships Operating in U.S. Waters_2.9.2022.docx Supporting Statement B	2022-03-15
Non-Sub Change 0920-1335 Conditional Sail Order Forms-8.10.2021.docx Justification for No Material/Nonsubstantive Change	2021-08-12
Non-Sub Change 0920-1335 Conditional Sail Order forms 05.20.21 (1).docx Justification for No Material/Nonsubstantive Change	2021-05-26
Dear Cruise Line Colleague Letter Announcing Phases 2B and 3 (005).pdf Supplementary Document	2021-05-26
Non-Sub Change 0920-1335 Conditional Sail Order forms_ (003).docx Justification for No Material/Nonsubstantive Change	2021-05-05
ZA24_TI for Simulated Voyages_5.4.2021.docx Supplementary Document	2021-05-05
ZA24_Operations Manual for COVID-19 Prevention and Control_5.4.2021.docx Supplementary Document	2021-05-05
Attachment O Request for Information FRN.pdf Supplementary Document	2021-04-19
Attachment J. Maritime Conveyance Illness or Death Reporting Form.pdf Supplementary Document	2021-04-19
Attachment I. Maritime Conveyance Cumulative ILI.pdf Supplementary Document	2021-04-19
Attachment G. Local Health Authority and Port Agreement Checklist.docx Supplementary Document	2021-04-19
Attachment E No Sail Order FRN.pdf Supplementary Document	2021-04-19
Attachment D. Acknowledgement of No Sail Order Response Plan.pdf Supplementary Document	2021-04-19
Attachment C Framework for Conditional Sail FRN.pdf Supplementary Document	2021-04-19
A3. 42 CFR part 71.docx Supplementary Document	2021-04-19
A2. 42 CFR 70.docx Supplementary Document	2021-04-19
A1. 361 and 365 PHSA.pdf Supplementary Document	2021-04-19
Supporting Statement A_0920-1335_CDC COVID19 Program for Cruise Ships Operating in U.S. Waters_2.9.2022.docx Supporting Statement A	2022-03-15

IC Document Collections

IC ID	Document Title	Status
263080	Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (submitted sooner than 24 hours before arrival in U.S because 3% or more of the voyage's passengers or crew have ARI) Form	New
252174	COVID-19 Program for Cruise Ships Notice of Participation/Nonparticipation Form	Unchanged
252173	Cruise Ship Vaccination Status Classification Form	Unchanged
248858	Cruise Ship Physician - COVID-19 Contact Investigation Worksheet (if necessary) Form	Unchanged
248855	Cruise Ship Physician - COVID-19 Case Investigation Worksheet (if necessary) Form	Unchanged
246889	Cruise Ship Operator - Remote and In-person Inspections Instruction	Unchanged
246885	Cruise Ship Brand/Operator - Agreement with Housing Facility with signoff from Local Health Authorities Instruction	Unchanged
246884	Cruise Ship Operator - Agreement with Port of Entry with signoff from Local Health Authority Instruction	Unchanged
246883	Cruise Ship Brand/Operator - Agreement with Health Care Organization with signoff from Local Health Authorities Instruction	Unchanged
246878	Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form (submitted once per voyage, within 24 hours before arrival in U.S.) Form	Modified
246872	Cruise Ship Holding Company - COVID-19 Response Plan Instruction	Unchanged

ICR Details

OMB Control No: 0920-1335	ICR Reference No: 202310-0920-011
Status: Received in OIRA	Previous ICR Reference No: 202306-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1335-24AN
Title: [NCEZID] Phased Approach to the Resumption of Cruise Ship Passenger Operations
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/31/2023

	Requested	Previously Approved
Expiration Date	01/31/2026	01/31/2026
Responses	6,801	6,501
Time Burden (Hours)	2,765	2,715
Cost Burden (Dollars)	239,856	233,556

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Abstract: As part of its Phased Approach to the Resumption of Passenger Operations, CDC will collect information from cruise ships operating or intending to operate in U.S. waters. This phased approach includes increased reporting of COVID-19 and COVID-19 like illnesses as well as a number of information collections designed to ensure cruise ships can prevent, detect, and respond to outbreaks of COVID-19. This Extension of an existing Information Collection Request is submitted to allow collection to continue for an additional three years. The resumption of passenger voyages in the U.S. has facilitated the introduction and sustained transmission of COVID-19 among cruise ships, despite high vaccination rates among both crew and passengers, highlighting the continued need to temporarily extend CDC’s public health management to mitigate this risk. This Change Request is submitted to make modifications to the Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form and to request a small increase in Burden Hours (51) for cruise ships to report earlier if >3% of passengers or crew are sick so that CDC can provide technical assistance in managing the outbreak, and then again at the end of the voyage to monitor progression of the outbreak.

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Authorizing Statute(s): US Code: 42 USC CFR 71 Name of Law: Foreign Quarantine
   US Code: 42 USC 264 Name of Law: PHSA
   US Code: 42 USC CFR 70 Name of Law: Interstate Quarantine
  

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:
	86 FR 22964	04/30/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 12706	03/07/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
COVID-19 Program for Cruise Ships Notice of Participation/Nonparticipation	0920-1335	Attachment E_Notice of Participation-Nonparticipation
Cruise Ship Brand/Operator - Agreement with Health Care Organization with signoff from Local Health Authorities	0920-1335	Attachment N_Agreement with Health Care Organization
Cruise Ship Brand/Operator - Agreement with Housing Facility with signoff from Local Health Authorities	0920-1335	Attachment O_Agreement with Housing Facility
Cruise Ship Holding Company - COVID-19 Response Plan
Cruise Ship Operator - Agreement with Port of Entry with signoff from Local Health Authority	0920-1335	Attachment M_Agreement with Port of Entry
Cruise Ship Operator - Remote and In-person Inspections
Cruise Ship Physician - COVID-19 Case Investigation Worksheet (if necessary)	0920-1335, 0920-1335	COVID-19 Case Investigation worksheet ,   Attachment K_Cruise COVID19 Case Investigation Worksheet
Cruise Ship Physician - COVID-19 Contact Investigation Worksheet (if necessary)	0920-1335	Attachment L_Cruise COVID19 Contact Investigation Worksheet
Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form (submitted once per voyage, within 24 hours before arrival in U.S.)	0920-1335, None	Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form ,   Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form (submitted once per voyage, within 24 hours before arrival in U.S.)
Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (submitted sooner than 24 hours before arrival in U.S because 3% or more of the voyage's passengers or crew have ARI)	0920-1335	Cruise Ship Physician - Cruise Ship Cumulative Acute Respiratory Illness (submitted sooner than 24 hours before arrival in U.S because 3% or more of the voyage’s passengers or crew have ARI)
Cruise Ship Vaccination Status Classification	0920-1335	Attachment F_Cruise Ship Vaccination Status Classification

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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	6,801	6,501	0	300	0	0
Annual Time Burden (Hours)	2,765	2,715	0	50	0	0
Annual Cost Burden (Dollars)	239,856	233,556	0	6,300	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: Change Request for 0920-1335 submitted to modify Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form and to request a small increase in Burden Hours (51) due to cruise ship reporting requirements.

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Annual Cost to Federal Government: $1,477,542

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     No

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: 10/31/2023

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