Phased Approach to the Resumption of Cruise Ship Passenger Operations

Forms and Documents

Document Name	Status
Form 0920-1335 COVID-19 Program for Cruise Ships Notice of Participation/Nonparticipation Form	New
Form 0920-1335 Cruise Ship Vaccination Status Classification Form	New
Form 0920-1335 Cruise Ship Physician - COVID-19 Contact Investigation Worksheet (if necessary) Form	Modified
Form 0920-1335 Cruise Ship Physician - COVID-19 Case Investigation Worksheet (if necessary) Form	Modified
Cruise Ship Operator - COVID-19 Conditional Sailing Certificate Application Form	Removed
Cruise Ship Operator - After Action Report - Simulated Voyage Form and Instruction	Removed
Cruise Ship Operator - Request for Approval to Conduct a Simulated Voyage Prior to Issuance of COVID-19 Conditional Sailing Certificate Form	Removed
Cruise Ship Operator - Acknowledgement by a Cruise Ship Operator in lieu of a Simulated Voyage (if applicable) Form	Removed
Form 0920-1335 Cruise Ship Physician - Enhanced Data Collection (EDC) During COVID-19 Pandemic Form (Daily) Form	Modified
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
252174	COVID-19 Program for Cruise Ships Notice of Participation/Nonparticipation Form	New
252173	Cruise Ship Vaccination Status Classification Form	New
249925	Cruie Ship Operator - Remote and In-Person Inspection Instruction	Removed
249924	Cruise Ship Operator - Modified Simulated Voyage Conducting Operations in non-U.S. Jurisdictions and Intend to Operate in U.S. Waters - less than 95% Vaccinated Instruction	Removed
249922	Cruise Ship Operator - Modified Simulated Voyage Procedure for Cruise Ships Currently Operating in U.S. Waters that Wish to Transition to Voyages with Less than 95% Vaccinated Passengers Instruction	Removed
249920	Cruise Ship Brand/Operator - Mass Crew Testing Requirement Instruction	Removed
248858	Cruise Ship Physician - COVID-19 Contact Investigation Worksheet (if necessary) Form	Modified
248855	Cruise Ship Physician - COVID-19 Case Investigation Worksheet (if necessary) Form	Modified
246891	Cruise Ship Operator - COVID-19 Conditional Sailing Certificate Application Form	Removed
246890	Cruise Ship Operator - After Action Report - Simulated Voyage Form and Instruction	Removed
246889	Cruise Ship Operator - Remote and In-person Inspections Instruction	Modified
246888	Passenger (3rd Party Disclosure) - Informed Consent and Medical Certification with no pre-existing conditions) for Simulated Voyage Instruction	Removed
246887	Cruise Ship Operator - Request for Approval to Conduct a Simulated Voyage Prior to Issuance of COVID-19 Conditional Sailing Certificate Form	Removed
246885	Cruise Ship Brand/Operator - Agreement with Housing Facility with signoff from Local Health Authorities Instruction	Modified
246884	Cruise Ship Operator - Agreement with Port of Entry with signoff from Local Health Authority Instruction	Modified
246883	Cruise Ship Brand/Operator - Agreement with Health Care Organization with signoff from Local Health Authorities Instruction	Modified
246882	Cruise Ship Operator - Acknowledgement by a Cruise Ship Operator in lieu of a Simulated Voyage (if applicable) Form	Removed
246880	Cruise Ship Brand/Operator - Approval of Onboard COVID-19 Testing Instrument Instruction	Removed
246878	Cruise Ship Physician - Enhanced Data Collection (EDC) During COVID-19 Pandemic Form (Daily) Form	Modified
246872	Cruise Ship Holding Company - COVID-19 Response Plan Instruction	Modified

ICR Details

OMB Control No: 0920-1335	ICR Reference No: 202203-0920-006
Status: Received in OIRA	Previous ICR Reference No: 202110-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1335
Title: Phased Approach to the Resumption of Cruise Ship Passenger Operations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/16/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2022
Responses	47,951	66,356
Time Burden (Hours)	17,532	24,289
Cost Burden (Dollars)	1,104,006	2,001,067

---

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.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

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

---

Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
COVID-19 Program for Cruise Ships Notice of Participation/Nonparticipation	0920-1335	Attachment E_Notice of Participation-Nonparticipation
Cruie Ship Operator - Remote and In-Person Inspection
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 Brand/Operator - Approval of Onboard COVID-19 Testing Instrument
Cruise Ship Brand/Operator - Mass Crew Testing Requirement
Cruise Ship Holding Company - COVID-19 Response Plan
Cruise Ship Operator - Acknowledgement by a Cruise Ship Operator in lieu of a Simulated Voyage (if applicable)	none, 0920-1335, 0920-1335	Attestation for Commercial Travel ,   Attestation by A Cruise Ship Operator In Lieu Of A Simulated Voyage ,   Acknowledgement by a Cruise Ship Operator In Lieu of a Simulated Voyage
Cruise Ship Operator - After Action Report - Simulated Voyage	0920-1335, none, 0920-1335	Simulated Voyage After-Action Report ,   Simulated Voyage After-Action Report ,   After Action Report - Simulated Voyage
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 - COVID-19 Conditional Sailing Certificate Application	none, 0920-1335, 0920-1335	Conditional Sailing Certificate Application ,   Conditional Sailing Certificate Application ,   COVID-19 Conditional Sailing Certificate Application
Cruise Ship Operator - Modified Simulated Voyage Conducting Operations in non-U.S. Jurisdictions and Intend to Operate in U.S. Waters - less than 95% Vaccinated
Cruise Ship Operator - Modified Simulated Voyage Procedure for Cruise Ships Currently Operating in U.S. Waters that Wish to Transition to Voyages with Less than 95% Vaccinated Passengers
Cruise Ship Operator - Remote and In-person Inspections
Cruise Ship Operator - Request for Approval to Conduct a Simulated Voyage Prior to Issuance of COVID-19 Conditional Sailing Certificate	none, 0920-1335, 0920-1335	Request for Approval to Conduct a Simulated Voyage ,   Request for Approval to Conduct a Simulated Voyage 05MAY2021 ,   Request for Approval to Conduct a Simulated Voyage (Prior to Issuance of COVID-19 Conditional Sailing Certificate)
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 - Enhanced Data Collection (EDC) During COVID-19 Pandemic Form (Daily)	0920-1335	Attachment H_Enhanced Data Collection During COVID
Cruise Ship Vaccination Status Classification	0920-1335	Attachment F_Cruise Ship Vaccination Status Classification
Passenger (3rd Party Disclosure) - Informed Consent and Medical Certification with no pre-existing conditions) for Simulated Voyage

---

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	47,951	66,356	0	-18,405	0	0
Annual Time Burden (Hours)	17,532	24,289	0	-6,757	0	0
Annual Cost Burden (Dollars)	1,104,006	2,001,067	0	-897,061	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 information collection request outlines the reporting and document retention requirements that are part of CDC’s COVID-19 Program for Cruise Ships Operating in U.S. Waters. CDC will provide cruise lines operating cruise ships with information about the COVID-19 program and how to contact CDC to opt in or opt out of the COVID-19 Program for Cruise Ships.The total estimated annual burden is 17,531.5 hours per year.

---

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

---

Common Form ICR:  No

---

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: 03/16/2022

---