[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Notices]
[Pages 60043-60047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-1355]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) submitted the information 
collection request titled Phased Approach to the Resumption of Cruise 
Ship Passenger Operations to the Office of Management and Budget (OMB) 
for review and approval. CDC previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' on April 
30, 2021, to obtain comments from the public and affected agencies. 
This collection accompanies a CDC Order entitled Temporary Extension 
and Modification of Framework for Conditional Sailing Order (CSO). CDC 
received twenty (20) comments related to the previous notice. This 
notice serves to allow an additional 30 days for public and affected 
agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:

    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden 
of the proposed collection of information, including the validity of 
the methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information 
to be collected;
    (d) Minimize the burden of the collection of information on 
those who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., 
permitting electronic submission of responses; and
    (e) Assess information collection costs.

    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th

[[Page 60044]]

Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Phased Approach to the Resumption of Cruise Ship Passenger 
Operations (OMB Control No. 0920-1335, Exp. 10/31/2021)--Extension--
National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Temporary Extension and Modification Framework for Conditional 
Sailing Order (here on referred to as the ``CSO Extension'') extends 
The Framework for Conditional Sailing Order published in the Federal 
Register on November 4, 2020, and continues to prohibit a cruise ship 
operator from commencing or continuing any regular passenger operations 
without a COVID-19 Conditional Sailing Certificate issued by HHS/CDC. 
This information collection request outlines the reporting and document 
retention requirements that are part of a phased approach to resuming 
passenger operations.
    The CSO Extension builds upon the phased-in approach to resume 
cruise ship passenger operations introduced by the CSO. Cruise ship 
operators who have already completed the process under the CSO will not 
have to resubmit any information under the CSO Extension and can 
continue sailing with passengers without interruption. As many cruise 
ship operators are now familiar with the CSO and its requirements, many 
aspects of the phased-in approach can be completed concurrently under 
the CSO Extension.
Phase 1
    Per CDC's CSO Extension, cruise ships operating or intending to 
operate in U.S. waters must acknowledge that a complete and accurate 
COVID-19 response plan (formerly referred to as ``No Sail Order (NSO) 
response plan'') is observed. The COVID-19 response plan, which can be 
submitted by a cruise ship holding company and apply to all cruise 
ships operated by the holding company's brands, must include: (1) 
Terminology and use of definitions that align with how CDC uses and 
defines the following terms: ``confirmed COVID-19,'' ``COVID-19-like 
illness,'' ``close contact,'' ``fully vaccinated for COVID-19,'' and 
``isolation'' and ``quarantine'' (including timeframes for isolation 
and quarantine); (2) protocols for on board surveillance of passengers 
and crew with COVID-19 and COVID-19-like illness; (3) protocols for 
training all crew on COVID-19 prevention, mitigation, and response 
activities; (4) protocols for on board isolation and quarantine, 
including how to increase capacity in case of an outbreak; (5) 
protocols for COVID-19 testing that aligns with CDC technical 
instructions; (6) protocols for onboard medical staffing--including 
number and type of staff--and equipment in sufficient quantity to 
provide a hospital level of care (e.g., ventilators, face masks, 
personal protective equipment) for the infected without the immediate 
need to rely on shoreside hospitalization; and (7) procedures for 
disembarkation of passengers who test positive for COVID-19.
    Phase 1 also includes requirements for COVID-19 testing 
capabilities and reporting for cruise ship operators operating or 
intending to operate cruise ships in U.S. waters. Cruise ship operators 
must have onboard testing capabilities to test all symptomatic crew and 
passengers for COVID-19 and their close contacts. This includes having 
onboard rapid nucleic acid amplification test (NAAT) point-of-care 
equipment that meets the requirements specified by CDC in technical 
instructions or orders and have received CDC approval. For the Phase 1 
mass crew testing requirement, cruise ship operators may use an onboard 
viral test (NAAT or antigen test) or arrange shoreside testing at a 
Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory 
so long as it meets the requirements specified by CDC in technical 
instructions or orders and have received CDC approval.
    Finally, Phase 1 also includes reporting requirements using the CDC 
Enhanced Data Collection during COVID-19 Pandemic (EDC) form. In lieu 
of submitting the Maritime Conveyance Cumulative Influenza/Influenza-
Like Illness (ILI) Form for COVID-19-like illness and the Maritime 
Conveyance Illness or the Death Investigation Form for individual 
specific cases of COVID-19, the CDC will require daily submission of 
the EDC form during the period of the CSO Extension. Data points for 
this form include number of travelers (crew and passengers) currently 
onboard; case counts and diagnostic testing data for COVID-19 and 
COVID-19-like Illness (CLI); screening and testing of asymptomatic 
travelers, isolation practices, and the percentage of travelers who are 
fully vaccinated. The data collected in the EDC form are used to inform 
CDC's COVID-19 Color-Coding System for Cruise Ships. This data will 
greatly increase the transparency of the overall health of the crew 
members and passengers, and better allow the CDC to manage potential 
outbreaks and offer recommendations to the ship and port partners. The 
color-coding system is only applicable to cruise ships operating or 
planning to operate in U.S. waters. Status of ships is contingent upon 
daily submission of the EDC form. When a cruise ship notifies CDC of 
suspected or confirmed cases of COVID-19 on board, CDC determines 
whether an investigation is needed based on a predetermined threshold. 
If an investigation is deemed necessary, CDC will solicit extra 
information from the cruise ship operator. This investigation gives CDC 
and the cruise industry the ability to work closely together to protect 
the health and safety of those on board and in communities.
Phase 2A
    The next phase, Phase 2A, focuses on preparation for simulated and 
restricted voyages. As required under the CSO Extension, a cruise ship 
operator's agreement with U.S. port authorities and local health 
authorities must include the following elements: (1) A port agreement 
between the cruise ship operator and port authority that takes into 
consideration the public health response resources of the jurisdiction 
in the event of a COVID-19 outbreak, a plan and timeline for 
vaccination of cruise ship crew prior to resuming passenger operations, 
and vaccination strategies to maximally protect passengers and crew 
from introduction, amplification, and spread of COVID-19 in the 
maritime environment and in land-based communities; (2) medical care 
agreements between the cruise ship operator and health care entities, 
addressing evacuation and medical transport to onshore hospitals for 
passengers and crew in need of medical care, in accordance with CDC 
technical instructions and orders; and (3) housing agreements between 
the cruise ship operator and one or more shoreside facilities for 
isolation and quarantine of passengers or crew members with COVID-19 
and their close contacts, identified from the day of embarkation 
through disembarkation for each voyage. Cruise lines/brands may submit 
these agreements for all the ships in their fleet. Note, these 
agreements can remain in place for restricted voyages, as long as the 
agreements remain valid.
    In lieu of documenting the approval of all local health authorities 
of jurisdiction, the cruise ship operator may instead submit to CDC a 
signed statement from a local health authority, on the health 
authority's official letterhead, indicating that the health

[[Page 60045]]

authority has declined to participate in deliberations and/or sign the 
port agreement (i.e., a ``Statement of Non-Participation''). 
Additionally, the cruise ship operator may enter into a multi-port 
agreement (as opposed to a single port agreement) provided that all 
relevant port and local health authorities (including the state health 
authorities) are signatories to the agreement.
    During discussions with cruise ship operators, port authorities, 
and state and local health authorities, all parties requested CDC 
assistance with the required agreements. In response to these requests, 
CDC has posted specific guidance online and has provided a checklist 
for additional reference.
Phase 2B
    Phase 2B of the CSO Extension establishes the requirements for 
simulated voyages where volunteers play the role of passengers to test 
cruise ship operators' ability to mitigate COVID-19 onboard. Passengers 
on simulated voyages must be at least 12 years old, provide their 
informed consent, and submit a medical certification to the cruise ship 
operator prior to embarkation.
    Before conducting a simulated voyage, a cruise ship operator must 
submit a Request for Approval to Conduct a Simulated Voyage Prior to 
Issuance of COVID-19 Conditional Sailing Certificate at least five 
business days prior to the voyage. A cruise ship operator shall not 
apply for approval to conduct a simulated voyage until all of CDC's 
requirements relating to onboard laboratory capacity and screening 
testing of crew in U.S. waters have been satisfied.
    A simulated voyage must include the following simulated activities: 
(1) Embarkation and disembarkation procedures, including terminal 
check-in, (2) on board activities, including at dining and 
entertainment venues, (3) private island shore excursions, if any are 
planned during restricted passenger voyages, (4) evacuation procedures, 
(5) transfer of symptomatic passengers or crew, or those who test 
positive for SARS-CoV-2, from cabins to isolation rooms, (6) quarantine 
of all remaining passengers and non-essential crew, and (7) other 
activities as may be listed in CDC technical instructions and orders.
    Additionally, the cruise ship operator must: (1) Meet standards for 
hand hygiene, facemasks, and physical distancing for passengers and 
crew, as well as ship sanitation, as may be required by CDC technical 
instructions or orders, (2) conduct laboratory testing of all 
passengers and crew on the day of embarkation and the day of 
disembarkation as required by CDC technical instructions or orders, and 
(3) immediately conduct laboratory testing of any passengers and crew 
who report illness consistent with COVID-19 during the simulated voyage 
with rapid point-of-care results as required by CDC technical 
instructions or orders. Note, CDC may require the cruise ship operator 
to immediately end the simulated voyage and take other action to 
protect the health and safety of volunteer passengers and crew if 
during the simulation a threshold of COVID-19 cases, as determined by 
CDC in technical instructions, is met or exceeded.
    During simulated voyages, the cruise ships are subject to virtual 
and in-person inspections by CDC. The cruise ship operator's properties 
and records must be made available for inspection to allow CDC to 
ascertain compliance with its requirements. Such properties and records 
include but are not limited to vessels, facilities, vehicles, 
equipment, communications, manifests, list of passengers, laboratory 
test results, and employee and passenger health records. CDC has issued 
additional technical guidance outlining the specific areas that may be 
inspected and corresponding recommendations. Following each simulated 
voyage, the cruise ship operator must document any deficiencies in its 
health and safety protocols through a Simulated Voyage After-Action 
Report and address how the cruise ship operator intends to address 
those deficiencies. This After-Action Report must also include COVID-19 
test results for any volunteer passengers or crew on the simulated 
voyage. The After-Action Report must be submitted to the CDC as soon as 
practicable at the end of the simulation and as part of the cruise ship 
operator's application for a COVID-19 Conditional Sailing Certificate.
    In lieu of conducting a simulated voyage, a cruise ship operator's 
responsible officials, at their discretion, may sign and submit to CDC 
an acknowledgement that 95% of crew (excluding any newly embarking crew 
in quarantine) are fully vaccinated and submit to CDC a clear and 
specific vaccination plan and timeline to limit cruise ship sailings to 
95% of passengers who have been verified by the cruise ship operator as 
fully vaccinated prior to sailing.
    Furthermore, cruise ships that have been operating restricted 
passenger voyages under an Acknowledgement by a Cruise Ship Operator In 
Lieu of a Simulated Voyage may, at their discretion, transition to 
operating restricted passenger voyages with less than 95% of passengers 
fully vaccinated without first conducting a simulated voyage if the 
following are met: (1) The ship must maintain a percentage of fully 
vaccinated crew that is greater than or equal to 95%. (2) The ship must 
have operated on restricted passenger voyages under an acknowledgement 
by the cruise ship operator's responsible officials that they will only 
operate with 95% of crew (excluding any newly embarking crew in 
quarantine) and 95% of passengers who are fully vaccinated for at least 
60 days. (3) At least 14 days prior to the transition to voyages with 
less than 95% of passengers fully vaccinated, the cruise ship operator 
must submit the following to CDC: (1) Protocols for how dining and 
entertainment venues, and recreational activities including buffets, 
seated dining, bars (including between bartenders and patrons), 
theaters, other performance venues, casinos, arcade room, spa services, 
fitness classes/gymnasiums, muster drills, and other areas where 
passengers congregate will be modified to incorporate mask use, 
physical distancing, and other public health measures as outlined in 
CDC technical instructions. (2) Plans for training crew on new 
procedures for mask use, physical distancing, and other public health 
measures as outlined in CDC technical instructions. (3) Protocols for 
increasing the number of isolation and quarantine cabins and on-board 
support staff (e.g., administrative personnel, testing personnel, 
contact tracers, medical personnel) as determined by the cruise ship 
operator and as needed in the event of an outbreak. (4) Procedures for 
how crew will identify and distinguish between passengers who are fully 
vaccinated and passengers who are not fully vaccinated. (5) Procedures 
for notifying passengers who booked a 95% passenger vaccinated cruise 
that their cruise will no longer operate as a 95% passenger vaccinated 
cruise. (6) The cruise ship operator must submit photographs or videos, 
no later than seven days after commencing the first voyage with less 
than 95% of passengers fully vaccinated, showing compliance with indoor 
mask use and physical distancing, such as signage in elevators, dining 
table arrangements, and blocking out seats/bar stools.
    Similarly, cruise ship operators that have been conducting 
passenger operations outside of U.S. waters and intend to operate 
cruise ships with less than 95% of passengers fully vaccinated after 
repositioning to U.S. waters may, at their discretion, follow the

[[Page 60046]]

procedures in this paragraph for conducting a modified simulated voyage 
instead of conducting a full simulated voyage if the following are met: 
(1) The ship must maintain a percentage of fully vaccinated crew that 
is greater than or equal to 95%. (2) The ship must have operated with 
passengers outside of U.S. waters for at least 60 days before entering 
U.S. waters. (3) The cruise ship operator must conduct at least one 
simulation of embarkation screening and testing at the port terminal it 
intends to use in the U.S.--to include the number of passengers not 
fully vaccinated expected on the first voyage--unless the ship will be 
operating at the terminal already in use by the same cruise line/brand 
for passenger operations. (4) At least 14 days prior to entering U.S. 
waters, the cruise ship operator must submit the following to CDC: (i) 
Protocols for how dining and entertainment venues, and recreational 
activities, including buffets, seated dining, bars (including between 
bartenders and patrons), theaters, other performance venues, casinos, 
arcade room, spa services, fitness classes/gymnasiums, muster drills, 
and other areas where passengers congregate will incorporate mask use, 
physical distancing, and other public health measures as outlined in 
technical instructions. (ii) Plans for training crew on procedures for 
mask use, physical distancing, and other public health measures as 
outlined in CDC technical instructions. (iii) Protocols for increasing 
the number of isolation and quarantine cabins and on-board support 
staff (e.g., administrative personnel, testing personnel, contact 
tracers, medical personnel) as determined by the cruise ship operator 
and as needed in the event an outbreak. (iv) Procedures for how crew 
will identify and distinguish between passengers who are fully 
vaccinated and passengers who are not fully vaccinated. (v) Procedures 
for notifying passengers who booked a 95% vaccinated cruise that their 
cruise will no longer operate as a 95% vaccinated cruise, if 
applicable. (vi) An after-action report explaining lessons learned from 
sailing outside of U.S. waters and from the simulated embarkation 
screening and testing (if such a simulation was conducted). (vii) The 
cruise ship operator must submit photographs or videos, no later than 
seven days after commencing the first voyage with less than 95% of 
passengers fully vaccinated, showing compliance with indoor mask use 
and physical distancing, such as signage in elevators, dining table 
arrangements, and blocking out seats/bar stools.
Phase 3
    As a condition of applying for a COVID-19 Conditional Sailing 
Certificate (Phase 3), a cruise ship operator must have successfully 
conducted a simulated voyage, submitted an Acknowledgement by a Cruise 
Ship Operator In Lieu of a Simulated Voyage, or--if applicable--
completed the specific modified simulated voyage procedures described 
above. The CDC COVID-19 Conditional Sailing Certificate Application 
must include: (1) A completed CDC registration/application form that 
includes the signatures of the cruise ship operator's responsible 
officials; (2) The name, titles, and contact information for the cruise 
ship operator's responsible officials; (3) A completed statement of 
intent stating the name, carrying capacity for passengers and crew, 
itinerary, ports of call, length of voyage, and expected onboard or 
shoreside activities, for the cruise ship that the cruise ship operator 
intends to have certified for restricted passenger operations; (4) a 
certification statement signed by the responsible officials attesting 
that the cruise ship operator has complied and remains in compliance 
with CDC's requirements for a COVID-19 Response Plan and EDC reporting 
prior to applying for a COVID-19 Conditional Sailing Certificate; (5) a 
certification statement signed by the responsible officials attesting 
that the cruise ship operator has adopted health and safety protocols 
that meet CDC's standards for mitigating the risk of COVID-19 among 
passengers and crew onboard the cruise ship that will be commencing 
restricted passenger operations, and will modify these protocols as 
needed to protect the public's health as required by CDC technical 
instructions or orders; (6) a certification statement signed by the 
responsible officials attesting that the cruise ship operator has 
sufficient medical and point of care laboratory capabilities and staff 
on board the cruise ship that will be commencing restricted passenger 
operations to manage severe COVID-19 cases and outbreaks in exigent 
circumstances as required by CDC technical instructions or orders; and 
(7) a certification statement signed by the responsible officials 
attesting that the cruise ship operator is in compliance with the other 
requirements contained in this framework for mitigating the risk of 
COVID-19 on board cruise ships and agrees to continue to comply with 
these requirements.
    These documents must be submitted at least five business days prior 
to any proposed restricted voyage. If the Certificate is denied, 
revoked or suspended, a cruise ship operator may submit a written 
appeal of a denial of its application for a COVID-19 Conditional 
Sailing Certificate or a revocation or suspension of its COVID-19 
Conditional Sailing Certificate.
    During restricted voyages, the cruise ships are subject to virtual 
and in-person inspections by CDC. The cruise ship operator's properties 
and records must be made available for inspection to allow CDC to 
ascertain compliance with its requirements. Such properties and records 
include but are not limited to vessels, facilities, vehicles, 
equipment, communications, manifests, list of passengers, laboratory 
test results, and employee and passenger health records. CDC has issued 
additional technical guidance outlining the specific areas that may be 
inspected and corresponding recommendations. CDC has provided, and will 
continue to provide, the technical instructions for each phase as they 
are released through a non-substantive change request.
    CDC requests OMB approval for an estimated 24,146 annual burden 
hours to respondents and record keepers.

                                        Estimated Annualized Burden Hours
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                                                                                      Number      Average burden
         Type of respondent                   Form name              Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
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Cruise ship holding company........  COVID-19 Response Plan.....               3               1         2400/60
Cruise ship physician..............  Enhanced Data Collection                130             365           20/60
                                      (EDC) During COVID-19
                                      Pandemic Form (Daily).
Cruise ship physician..............  Cruise COVID-19 Case                    104               1           30/60
                                      Investigation Worksheet
                                      (if necessary).

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Cruise ship physician..............  Cruise COVID-19 Contact                  24               1           30/60
                                      Investigation Worksheet
                                      (if necessary).
Cruise ship brand/operator.........  Approval of Onboard COVID-               60               1           60/60
                                      19 Testing Instrument.
Cruise ship brand/operator.........  Mass Crew Testing                        60               1            5/60
                                      Requirement.
Cruise ship brand/operator.........  Agreement with Health Care               60               1          600/60
                                      Organization with signoff
                                      from Local Health
                                      Authorities.
Cruise ship brand/operator.........  Agreement with Port of                   60               1          600/60
                                      Entry with signoff from
                                      Local Health Authority.
Cruise ship brand/operator.........  Agreement with Housing                   60               1          600/60
                                      Facility with signoff from
                                      Local Health Authority.
Cruise ship operator...............  Request for Approval to                  30               1          600/60
                                      Conduct a Simulated Voyage
                                      Prior to Issuance of COVID-
                                      19 Conditional Sailing
                                      Certificate.
Passenger (3rd party disclosure)...  Informed Consent and                 18,000               1           15/60
                                      Medical Certification with
                                      no pre-existing conditions
                                      for Simulated Voyage.
Cruise ship operator...............  Remote and In-person                     30               1          120/60
                                      Inspections.
Cruise ship operator...............  After Action Report,                     30               1          600/60
                                      Simulated Voyage.
Cruise ship operator...............  COVID-19 Conditional                     60               1          600/60
                                      Sailing Certificate
                                      Application.
Cruise ship operator...............  Remote and In-person                    130               2          120/60
                                      Inspections.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-23555 Filed 10-28-21; 8:45 am]
BILLING CODE 4163-18-P