Framework for Conditional Sailing and Initial Phase COVID-19 Testing Requirements for Protection of Crew, 70153-70163 [2020-24477]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70153-70163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Framework for Conditional Sailing and Initial Phase COVID-19 
Testing Requirements for Protection of Crew

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), a 
component of the Department of Health and Human Services (HHS), 
announces a framework for a phased resumption of cruise ship passenger 
operations. CDC also announces requirements for the initial phases of 
this framework regarding testing of crew members for COVID-19, an 
integral part of the initial phases prior to resuming passenger 
operations. This Order applies to cruise ship operators with cruise 
ships operating in U.S. waters and cruise ship operators who are 
operating cruise ships outside of U.S. waters, but intend for their 
cruise ships to return to operating in U.S. waters while this Order 
remains in effect.

DATES: This action is effective October 30, 2020.

FOR FURTHER INFORMATION CONTACT: Jennifer Buigut, Division of Global 
Migration and Quarantine, Centers for Disease Control and Prevention, 
1600 Clifton Road NE, MS H16-4, Atlanta, GA 30329. Phone: 404-498-1600. 
Email: [email protected].

SUPPLEMENTARY INFORMATION: This Order establishes a framework for a 
phased approach to resuming cruise ship passenger operations in U.S. 
waters. This phased approach will include: (1) Establishment of 
laboratory testing of crew onboard cruise ships in U.S. waters; (2) 
simulated voyages designed to test a cruise ship operators' ability to 
mitigate COVID-19 onboard cruise ships; (3) a certification process; 
and (4) a return to passenger voyages in a manner that mitigates the 
risk of COVID-19 introduction, transmission, or spread among passengers 
and crew onboard ships and ashore to communities.
    As part of the initial crew testing phases, this Order additionally 
contains requirements for: (1) Shoreside COVID-19 laboratory screening 
testing of all crew currently onboard cruise ships; (2) onboard 
diagnostic testing capabilities for symptomatic travelers (crew and 
future passengers); (3) shoreside COVID-19 laboratory screening testing 
of all newly embarking crew; and (4) continued compliance with 
complete, accurate, and acknowledged, No Sail Order Response Plans.
    A copy of the Order is provided below and a copy of the signed 
order can be found at https://www.cdc.gov/quarantine/cruise/.

U.S. Department of Health and Human Services (HHS)--Centers for Disease 
Control and Prevention (CDC)

Order Under Sections 361 & 365 of the Public Health Service Act (42 
U.S.C. 264, 268) and 42 Code of Federal Regulations Part 70 
(Interstate) and Part 71 (Foreign): Framework for Conditional Sailing 
and Initial Phase COVID-19 Testing Requirements for Protection of Crew

Executive Summary

    The Centers for Disease Control and Prevention (CDC), a component 
of the U.S. Department of Health and Human Services (HHS), announces 
this framework for a phased resumption of cruise ship passenger 
operations. Considering the continued spread of COVID-19 worldwide and 
increased risk of COVID-19 on cruise ships, a careful approach is 
needed to safely resume cruise ship passenger operations. CDC is 
establishing requirements to mitigate the COVID-19 risk to passengers 
and crew, prevent the further spread of COVID-19 from cruise ships into 
U.S. communities, and protect public health and safety. After 
expiration of CDC's No Sail Order (NSO) on October 31, 2020, CDC will 
take a phased approach to resuming cruise ship passenger operations in 
U.S. waters.
    The initial phases will consist of testing and additional 
safeguards for crew members. CDC will ensure cruise ship operators have 
adequate health and safety protections for crew members while these 
cruise ship operators build the laboratory capacity needed to test 
future passengers. Subsequent phases will include simulated voyages to 
test cruise ship operators' ability to mitigate COVID-19 risk, 
certification for ships that meet specific requirements, and a phased 
return to cruise ship passenger voyages in a manner that mitigates 
COVID-19 risk among passengers, crew members, and U.S. communities. 
These phases are subject to change based on public health 
considerations and cruise ship operators' demonstrated ability to 
mitigate COVID-19 risk. CDC will issue additional orders as needed that 
will be published in the Federal Register and technical instructions 
that will be subsequently posted on CDC's website.
    This Order additionally announces requirements for the initial 
phases relating to crew testing. CDC considers adequate crew safeguards 
as demonstrated through laboratory testing for SARS coronavirus 2 
(SARS-CoV-2), the virus that causes COVID-19, an integral part of the 
initial phases prior to resuming passenger operations.

Previous Orders and Incorporation by Reference

    The findings and other evidence relied upon in issuing the No Sail 
Order and Other Measures Related to Operations signed by the CDC 
Director on March 14, 2020,\1\ as further modified and extended 
effective April 15, 2020,\2\ July 16, 2020,\3\ and September 30, 2020 
\4\--are incorporated herein by reference.
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    \1\ No Sail Order and Suspension of Further Embarkation. https://www.federalregister.gov/documents/2020/03/24/2020-06166/no-sail-order-and-suspension-of-further-embarkation. Last accessed October 
19, 2020.
    \2\ No Sail Order and Suspension of Further Embarkation; Notice 
of Modification and Extension and Other Measures Related to 
Operations. https://www.federalregister.gov/documents/2020/04/15/2020-07930/no-sail-order-and-suspension-of-further-embarkation-notice-of-modification-and-extension-and-other. Last accessed 
October 19, 2020.
    \3\ No Sail Order and Suspension of Further Embarkation, Second 
Modification and Extension of No Sail Order and Other Measures 
Related to Operations. https://www.federalregister.gov/documents/2020/07/21/2020-15810/no-sail-order-and-suspension-of-further-embarkation-second-modification-and-extension-of-no-sail. Last 
accessed October 19, 2020.
    \4\ No Sail Order and Suspension of Further Embarkation; Third 
Modification and Extension of No Sail Order and Other Measures 
Related to Operations. https://www.federalregister.gov/documents/2020/10/05/2020-22030/no-sail-order-and-suspension-of-further-embarkation-third-modification-and-extension-of-no-sail. Last 
accessed October 19, 2020.
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Statement of Intent

    This Order shall be interpreted and implemented in a manner as to 
achieve the following paramount objectives:
     Preserving human life;
     Preserving the health and safety of cruise ship crew 
members, port personnel, and communities;
     Preventing the further introduction, transmission, and 
spread of COVID-19 into and throughout the United States;
     Preserving the public health and other critical resources 
of Federal, State, and local governments;

[[Page 70154]]

     Preserving hospital, healthcare, and emergency response 
resources within the United States; and
     Maintaining the safety of shipping and harbor conditions.

Acronyms, Initialisms, and Definitions

    (a): The acronyms and initialisms below will have the following 
meaning:
    aCLI means additional COVID-like illness signs and symptoms as 
defined by the Council of State and Territorial Epidemiologists (CSTE) 
and that are not included in the definitions of ARI, ILI, or pneumonia, 
or as defined by CDC in technical instructions. CDC will use the most 
current CSTE definition in effect, which may be found at: https://wwwn.cdc.gov/nndss/conditions/coronavirus-disease-2019-covid-19/.
    ARI means Acute Respiratory Illness defined as the presence of 
cough, sore throat, or runny nose (rhinorrhea) in the absence of fever 
and in the absence of a non-infectious diagnosis (e.g., allergies) as 
determined by the ship's medical provider, or as defined by CDC in 
technical instructions.
    CLI means COVID-like Illness.
    CDC means U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, or an authorized representative acting 
on its behalf.
    EDC means Enhanced Data Collection.
    ILI means influenza-like illness defined as fever (>=100.4 [deg]F 
[38 [deg]C]) plus either cough or sore throat or as defined by CDC in 
technical instructions.
    USCG means United States Coast Guard, Department of Homeland 
Security.
    (b): The terms below will have the following meaning:
    Controlled Free Pratique has the same meaning as under 42 CFR 71.1.
    COVID-19 means the disease caused by the coronavirus SARS-CoV-2.
    COVID-like Illness means ARI, ILI, pneumonia, aCLI, or other signs 
or symptoms of COVID-like illness as defined by CDC in technical 
instructions.
    Crew or Crew member means any individual serving on board a cruise 
ship who is assigned to perform regular duties or tasks on behalf of a 
cruise ship operator in exchange for compensation.
    Cruise ship means any commercial, non-cargo, passenger-carrying 
vessel operating in U.S. waters with the capacity to carry 250 or more 
individuals (passengers and crew) with an itinerary anticipating an 
overnight stay onboard or a twenty-four (24) hour stay onboard for 
either passengers or crew.\5\
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    \5\ Cruise ships are defined in the same manner as in CDC's No 
Sail Orders, as extended and modified, that were issued between 
March 14 and September 30, 2020. CDC continues to define cruise 
ships in this manner based on substantial epidemiologic evidence 
related to congregate settings and mass gatherings. While evidence 
shows that outbreaks can occur in small settings such as nursing 
homes, as the numbers of passengers and crew on board a ship 
increase, certain recommended mitigation efforts such as social 
distancing become more difficult to implement. Considering the 
demonstrated rapid spread of COVID-19, the application of this 
framework to cruise ships carrying 250 or more passengers and crew 
remains prudent and warranted.
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    Cruise ship operator means the master of the vessel (cruise ship) 
and any other crew member responsible for cruise ship operations and 
navigation, as well as any person or entity (including a corporate 
entity) that authorizes or directs the use of a cruise ship (e.g., as 
owner, lessee, or otherwise). A cruise ship operator may also include 
the cruise ship captain or the cruise line to which the cruise ship 
belongs, and the officers and directors of the cruise line.
    Director means the Director of the Centers for Disease Control and 
Prevention, U.S. Department of Health and Human Services, or an 
authorized representative.
    Isolation means measures taken by a cruise ship operator to ensure 
the onboard or onshore separation of passengers or crew displaying 
signs or symptoms of COVID-19, or who have tested positive SARS-CoV-2, 
from other passengers or crew who do not display such signs or symptoms 
or have not tested positive for SARS-CoV-2.
    Laboratory Testing or Laboratory Test Results means testing 
performed in a laboratory certified as meeting the standards of the 
Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 U.S.C. 
263a) and 42 CFR part 493 or CLIA-waived point-of-care testing or the 
results of such testing. Testing must be performed using tests that are 
approved, cleared, or authorized for emergency use by the U.S. Food and 
Drug Administration (FDA) as specified by CDC in technical instructions 
or orders.
    Operate or Operating in U.S. waters means any action by a cruise 
ship operator to bring or cause a cruise ship to be brought into or 
transit in or between any waterways (e.g., shifting berths, moving to 
anchor, discharging waste, making port, or embarking or disembarking 
passengers or crew) subject to the jurisdiction of the United States.
    Passenger means any individual being transported or offered 
transport on board a cruise ship who is not a crew member, excluding 
U.S. government personnel.
    Passenger operations means any action by a cruise ship operator to 
cause passengers to embark or disembark a cruise ship.
    Person means any individual or partnership, firm, company, 
corporation, association, organization, or other legal entity.
    Quarantine means measures taken by a cruise ship operator to ensure 
the onboard or onshore separation and restriction of movement of 
passengers or crew who were potentially exposed to a person with COVID-
19 while that person was considered infectious.
    Responsible officials means the Chief Executive Officer (or 
equivalent) of the operating cruise company and all parent companies, 
the Chief Compliance Officer (or equivalent) of the operating cruise 
company and all parent companies, and the highest-ranking Medical 
Officer of the operating cruise company and all parent companies.
    Simulated voyage means a mock voyage or series of mock voyages 
designed and implemented in so far as possible to replicate real world 
onboard conditions of cruising with measures in place to mitigate the 
risk of COVID-19.
    Social distancing means maintaining a distance of at least 6 feet 
between one individual and another individual, not gathering in groups, 
and avoiding crowded places and mass gatherings.
    U.S. waters means any international, interstate, or intrastate 
waterways that are subject to the jurisdiction of the United States.

Background and Need To Establish a Framework for Mitigating the Risk of 
COVID-19 Onboard Cruise Ships Prior to Resuming Passenger Operations

    The coronavirus disease 2019 (COVID-19) pandemic continues to 
spread rapidly around the world with no U.S. Food and Drug 
Administration (FDA) authorized vaccine. As of October 30, 2020, a 
cumulative total of over 44 million cases and nearly 1.2 million 
confirmed deaths have now been reported worldwide. Even in countries 
that have managed to slow the rate of transmission, the risks for 
COVID-19 resurgence remains. In the United States, as of October 29, 
2020, there have been over 8.8 million cases and over 227,000 confirmed 
deaths. Based on the evidence gathered and explained in the No Sail 
Order issued on March 14, as modified and extended on April 15, July 
16, and September 30, 2020, there is ample reason to believe that 
absent mitigation measures of the type needed to prevent further 
transmission, cruise ship travel has the potential to exacerbate and 
amplify the spread of SARS coronavirus 2 (SARS-CoV-2) the virus that 
causes COVID-19.

[[Page 70155]]

    Unrestricted cruise ship travel would likely exacerbate and amplify 
the spread of SARS coronavirus 2 (SARS-CoV-2) the virus that causes 
COVID-19. On January 20, 2020, the Diamond Princess cruise ship 
departed Yokohama, Japan. On January 25, 2020, a symptomatic passenger 
departed the ship in Hong Kong, where he was later confirmed to have 
COVID-19. Upon the ship's return to Yokohama, Japanese authorities 
quarantined all passengers and crew on board the ship. Among the 3,711 
Diamond Princess passengers and crew, 712 (19.2%) were subsequently 
confirmed to have COVID-19, 37 required intensive care, and nine died. 
Following this outbreak, two voyages of the Grand Princess cruise ship 
were ultimately associated with 159 confirmed COVID-19 cases, including 
eight deaths.\6\
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    \6\ Moriarty LF, Plucinski MM, Marston BJ, et al. Public Health 
Responses to COVID-19 Outbreaks on Cruise Ships--Worldwide, 
February-March 2020. MMWR Morb Mortal Wkly Rep 2020;69:347-352. 
https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e3.htm. Last accessed 
June 25, 2020.
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    Because of these events, and the increased risk of transmission on 
cruise ships, on March 14, 2020, the CDC Director issued a No Sail 
Order and Other Measures Related to Operations directing cruise ships 
not voluntarily suspending operations to comply with certain measures 
(85 FR 16628). This followed a March 13, 2020, announcement by Cruise 
Line International Association (CLIA), the leading industry trade 
group, that its members would voluntarily suspend cruise ship 
operations. On March 17, 2020, CDC issued a Level 3 Travel Health 
Notice warning all travelers to defer cruise travel worldwide based on 
widespread ongoing transmission of COVID-19.\7\ Despite the 
announcement by CLIA, the application of the March 14, 2020 Order, and 
the Level 3 Travel Health Notice, cruise ships continued to be 
associated with new COVID-19 outbreaks. Between March 14 and April 15, 
2020, COVID-19 outbreaks were reported on several additional cruise 
ships with passengers (85 FR 21004).
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    \7\ CDC Travel Health Notice, COVID-19 and Cruise Ship Travel, 
at: https://wwwnc.cdc.gov/travel/notices/warning/coronavirus-cruise-ship (originally posted, March 17, 2020). Last accessed June 25, 
2020.
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    Accordingly, to protect public health and safety and prevent the 
further introduction, transmission, and spread of COVID-19 into and 
throughout the United States, the CDC Director issued No Sail Order and 
Suspension of Further Embarkation; Notice of Modification and Extension 
and Other Measures Related to Operations, modifying and extending the 
previous March 14, 2020 Order, which became effective on April 15, 2020 
(85 FR 21004). Under the April 15, 2020 Extension, as a condition of 
obtaining controlled free pratique \8\ to continue to engage in cruise 
ship operations in any international, interstate, or intrastate 
waterways subject to the jurisdiction of the United States, cruise ship 
operations were limited, and cruise lines were required to submit plans 
to prevent, mitigate, and respond to the spread of COVID-19 on board to 
ensure a safe work environment and disembarkation for crew members. A 
cruise ship operator's No Sail Order response plan had to minimize to 
the greatest extent possible any impact on U.S. Government operations 
or the operations of any State or local government, or the U.S. 
healthcare system. While working with cruise ship operators to ensure 
the completeness and accuracy of these response plans, CDC allowed crew 
members to disembark from cruise ships in U.S. waters and return home 
if cruise ship operators formally attested, in writing, to complying 
with requirements to disembark crew members in such a manner as to 
minimize the risk to other travelers and communities.
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    \8\ Under 42 CFR 71.1, controlled free pratique means permission 
for a carrier to enter a U.S. port, disembark, and begin operation 
under certain stipulated conditions.
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    Following the April 15, 2020 Extension, CDC published its Interim 
Guidance for Mitigation of COVID-19 Among Cruise Ship Crew to assist 
cruise ship operators in preventing, detecting, and medically managing 
confirmed and suspected SARS-CoV-2 infections and exposures among crew 
members.\9\ During this period, CDC also further assisted cruise ship 
operators with humanitarian medical evacuations for people in need of 
lifesaving support. Under the April 15, 2020 Extension, CDC established 
an enhanced surveillance process to provide a more complete picture of 
COVID-19 activity on cruise ships through a requirement for weekly 
submission of the ``Enhanced Data Collection (EDC) During COVID-19 
Pandemic Form (OMB Control Number 0920-0134, exp. 03/31/2022)''. Since 
then, the EDC form has been used to conduct surveillance for COVID-19 
among crew who remained on board cruise ships based on cumulative 
reports of acute respiratory illness (ARI),\10\ influenza-like illness 
(ILI),\11\ pneumonia, and other clinical indicators of COVID-19 (85 FR 
62732).
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    \9\ CDC, Interim Guidance for Mitigation of COVID-19 Among 
Cruise Ship Crew at: https://www.cdc.gov/quarantine/cruise/management/interim-guidance-no-sail-order.html
    \10\ Acute Respiratory Illness (ARI) is defined as the presence 
of cough, sore throat, or rhinorrhea in the absence of fever.
    \11\ Influenza-like Illness (ILI) is defined as fever (100.4 
[deg]F [38 [deg]C]) plus either cough or sore throat.
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    As of October 30, 2020, EDC reports have shown a total of 6,725 
polymerase chain reaction (PCR) tests performed, 296 (4%) of which were 
positive; 24 hospitalizations; 2 instances of mechanical ventilation; 
and 15 medical evacuations for crew on ships within U.S. jurisdiction 
since April 15, 2020. CDC also recommended that ships' surveillance 
include routine testing for SARS-CoV-2 infection, including 
intermittent testing of a random sample of symptomatic and asymptomatic 
crew members.
    In addition to reviewing the No Sail Order response plans, CDC 
continued to update its Interim Guidance as new information became 
available; provided technical expertise to ships with ongoing 
outbreaks; created cruise ship-specific websites to inform crew 
members, the public, and partners; and reviewed hundreds of written 
attestations submitted by cruise operators for safe disembarkation and 
transfer of crew members.
    CDC established a ``COVID-19 Color Coding System'' for ships 
applicable to cruise ship operators with an appropriate No Sail Order 
response plan for crew management. Classification of ships under this 
system requires cruise company officials to sign an acknowledgment of 
the completeness and accuracy of their No Sail Order response plans 
upon completion of CDC review of the plan. CDC assesses the status of a 
ship by reviewing surveillance data from the weekly EDC form as well as 
recent embarkations or crew transfers. Additional details regarding the 
color-coding system and color coding status for individual ships (which 
is updated weekly) may be found at https://www.cdc.gov/coronavirus/2019-ncov/travelers/crew-disembarkations-commercial-travel.html.
    To continue to protect public health and safety, and prevent the 
further introduction, transmission, and spread of COVID-19 into and 
throughout the United States, the CDC Director signed a Second 
Modification and Extension of No Sail Order and Other Measures Related 
to Operations on July 16, 2020, (85 FR 44085), and Third Modification 
and Extension of No Sail Order and Other Measures Related to Operations 
on September 30, 2020, (85 FR 62732).

[[Page 70156]]

This last order, among other things, continued to suspend passenger 
operations on board cruise ships through October 31, 2020.
    Current scientific evidence suggests that, absent mitigation 
measures of the type needed to prevent further transmission, cruise 
ships would continue to pose a greater risk of COVID-19 transmission 
than other settings. A recent article published in the Journal of 
Travel Medicine by Rockl[ouml]v et al. demonstrated that the Diamond 
Princess cruise ship experienced an onboard R0 (basic 
reproduction rate) for COVID-19 of 14.8 before ship-wide quarantine was 
enacted.\12\ This means that each case onboard the Diamond Princess 
transmitted COVID-19 to approximately 15 other people. This 
reproduction rate is approximately four times higher than the 
R0 of the original epicenter of the outbreak in Wuhan, 
China, which was 3.7, meaning that each person with COVID-19 in the 
early days of the outbreak in Wuhan transmitted the disease to 
approximately four other people. In late February/early March, 149 
cases of PCR-confirmed COVID-19 (of 589 tour participants) were found 
among U.S. residents linked to Egyptian Nile Cruises. This heightened 
rate of transmission onboard cruise ships has also been documented in 
other academic publications.1 13 Absent 
appropriate interventions to mitigate the spread of COVID-19, cruise 
ship conditions would likely amplify the spread of an already highly 
transmissible disease.
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    \12\ Rockl[ouml]v J, Sj[ouml]din H, Wilder-Smith A. COVID-19 
Outbreak on the Diamond Princess Cruise Ship: Estimating the 
Epidemic Potential and Effectiveness of Public Health 
Countermeasures. J. Travel Med. 2020; 18;27(3):taaa030. doi: 
10.1093/jtm/taaa030.
    \13\ Payne DC, Smith-Jeffcoat SE, Nowak G, et al. SARS-CoV-2 
Infections and Serologic Responses from a Sample of U.S. Navy 
Service Members--USS Theodore Roosevelt, April 2020. MMWR Morb 
Mortal Wkly Rep 2020;69:714-721. DOI: https://dx.doi.org/10.15585/mmwr.mm6923e4.
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    Rockl[ouml]v et al. surmised that this heightened rate of 
transmission is due to the high population density on board ships, 
which are typically more densely populated than cities or most other 
living situations. While this is one contributing factor, CDC's 
surveillance data collected through the EDC form and acquired during 
the period of the No Sail Order show that drastically decreasing 
population on board, absent other interventions, is not enough to 
extinguish transmission. Other factors likely contributing to onboard 
transmission are crews' living and working in close quarters, in a 
partially enclosed environment, and where social distancing may prove 
challenging even with a limited number of people onboard.
    In addition, the recent investigation by Payne et al. of 
transmission onboard a U.S. Navy ship demonstrated high transmission 
rates and high rates of mild disease and asymptomatic infection among 
crew.\8\ These mild presentations and asymptomatic cases make case 
detection and isolation and quarantine practices based on clinical 
presentation alone challenging. Thus, covert spread of infection among 
crew may keep the virus circulating from one voyage to the next. This 
again stresses the need for appropriate interventions, including 
routine laboratory testing of crew, prior to restarting passenger 
operations.
    Several cruise ship operators have taken steps to improve their 
public health response to COVID-19. For example, under the co-
chairmanship of former Health and Human Services Secretary, Michael O. 
Leavitt, and former FDA Commissioner, Dr. Scott Gottlieb, two cruise 
lines, Royal Caribbean Group and Norwegian Cruise Line Holdings, 
assembled a ``Healthy Sail Panel'' of subject-matter experts from a 
variety of disciplines. The World Travel & Tourism Council (WTTC) and 
Carnival Corporation also recently hosted a global science summit on 
COVID-19 designed, ``to inform practical, adaptable and science-based 
solutions for mitigating and living with COVID-19.'' MSC Cruises 
further established its own industry-led panel with ``competency to 
review policy initiatives, technical innovations, or operational 
measures related to COVID-19.''
    To gather more information regarding industry-led efforts to 
respond to COVID-19 and solicit public input, on July 20, 2020, CDC 
published a Request for Information (RFI) in the Federal Register 
related to cruise ship planning and infrastructure, resumption of 
passenger operations, and additional summary questions (85 FR 44083). 
The document had a 60-day comment period that ended on September 21, 
2020 and nearly 13,000 comments were received.
    Respondents to the RFI included members of the public, the cruise 
industry, seaport authorities, and the travel and hospitality 
industries. A majority of respondents (approximately 75%) expressed 
support for the resumption of passenger cruising in the U.S. Most of 
these commenters, however, expressed the need for increased public 
health measures, including health screening, testing, mask use, social 
distancing, travel insurance, refunds, and shipboard public health 
capacity as important steps to take before cruising resumes. 
Approximately 25% of respondents, including many previous cruise 
passengers, were in favor of delaying the resumption of passenger 
cruising because of the current state of the pandemic, and supported 
waiting until a vaccine is widely available.
    Comments received related to the reduction of number of passengers, 
the need for routine testing of passengers and crew, social distancing, 
coordination between CDC and the cruise industry, limiting ports of 
call to private islands, agreements with local public health and 
medical facilities, and the economic benefits of cruising. 
Approximately 98% of respondents supported cruise ship operators 
denying boarding to passengers with COVID-like illness or confirmed 
COVID-19 infection, while approximately 65% of respondents supported 
denying boarding to passengers with known COVID-19 exposure in the 
previous 14 days before embarkation. A majority of respondents (74%) 
also supported requiring that cruise ship operators test passengers and 
crew prior to embarkation. Furthermore, approximately 90% of 
respondents supported cruise ship operators reducing passenger and crew 
loads to reduce the risk of COVID-19 transmission, while approximately 
85% supported the wearing of face masks by passengers. While CDC bases 
its public health determinations on the best available science and not 
on public opinion, the willingness of the public to accept measures to 
mitigate the risk of transmitting COVID-19 onboard cruise ships is 
noteworthy. Accordingly, CDC carefully considered these comments in 
drafting this framework.
    CDC also considered alternatives to this framework. One alternative 
considered was allowing cruise ship operators to return to unrestricted 
passenger operations without any public health oversight. This 
alternative was deemed unacceptable because cruise ship travel is known 
to contribute to COVID-19 transmission. Furthermore, mild presentations 
and asymptomatic cases make case detection and isolation and quarantine 
practices challenging absent robust testing. Thus, covert spread of 
infection among crew may keep the virus circulating from one voyage to 
the next and passengers infected on cruise ships could further spread 
COVID-19 into U.S. communities by traveling interstate after cruising. 
This would have the effect of increasing morbidity and mortality, and 
burdening federal, state, and local medical and public health 
infrastructure. This again stresses the

[[Page 70157]]

need for appropriate public health oversight.
    Public health oversight is further needed to correct a market 
failure stemming from information asymmetry, i.e., the public is often 
not fully informed in such a way to adequately determine the extent to 
which any given measure mitigates their personal risk, particularly in 
light of asymptomatic cases. CDC is therefore overcoming this market 
failure by ensuring that the measures taken by cruise ship operators 
are those that are most likely to adequately mitigate such risks.
    Another alternative considered was continuing to issue No Sail 
Orders as occurred between March 14 and September 30, 2020. However, 
this alternative was not found to be as optimal as the current 
framework. The benefits of this framework outweigh the costs of not 
allowing cruise ships to sail because it allows for flexibility where 
cruise ships have taken the necessary precautions to mitigate risk, 
while continuing to prohibit passenger operations onboard ships that 
have failed to implement such precautions. As such, the current 
framework represents a tailored approach that was determined to be 
preferable to the status quo No Sail Order. This framework allows for 
individual cruise lines to progress through phases at variable paces. 
This enables cruise lines successfully implementing public health 
measures to return to passenger operations more quickly while others by 
necessity may move more slowly. The framework not only encourages 
cruise lines that are more successful at mitigating the spread of 
COVID-19 but provides a realistic timeline that anticipates COVID-19 
continuing to be present and affecting cruise ship travel.
    While the actions taken by some cruise ship operators to improve 
their public health response to COVID-19 are encouraging, ongoing 
public health oversight is needed to ensure uniform standards for 
mitigating the communicable disease risk to crew and prospective 
passengers. The public health measures in this framework reflect CDC's 
considered views as to the minimum standards that must be in place 
prior to resuming passenger operations in a way that will mitigate the 
risk of COVID-19.
    CDC intends to take a phased approach to resuming passenger 
operations. These phases include: (1) Establishment of laboratory 
testing of crew onboard cruise ships in U.S. waters; (2) simulated 
voyages designed to test a cruise ship operators' ability to mitigate 
COVID-19 on cruise ships; (3) a certification process; and (4) a return 
to passenger voyages in a manner that mitigates the risk of COVID-19 
introduction, transmission, or spread among passengers and crew onboard 
ships and ashore to communities. These phases will be further 
determined based on public health considerations including the 
trajectory of COVID-19 transmission and the demonstrated ability of 
cruise ship operators to successfully employ measures that mitigate the 
risk of COVID-19.
    As part of the initial crew testing phases, this Order additionally 
contains requirements for: (1) Shoreside COVID-19 laboratory screening 
testing of all crew currently onboard; (2) onboard diagnostic testing 
capabilities for symptomatic travelers (crew and future passengers); 
(3) shoreside COVID-19 laboratory screening testing of all newly 
embarking crew; and (4) continued compliance by cruise ship operators 
with their complete, accurate, and acknowledged, No Sail Order Response 
Plans.

Findings and Immediate Action

    The continued spread of the COVID-19 pandemic worldwide, risk of 
resurgence in countries that have suppressed transmission, and ongoing 
concerns related to the restart of cruising, supports the establishment 
of a framework designed to mitigate the risk of COVID-19 onboard cruise 
ships.
    Accordingly, and consistent with 42 CFR 70.2, 71.31(b), and 
71.32(b), the Director of CDC (``Director'') continues to find that 
absent measures of the type needed to mitigate further transmission, 
cruise ship travel exacerbates the global spread of COVID-19, that the 
scope of this pandemic is inherently and necessarily a problem that is 
international and interstate in nature, and such transmission has not 
been controlled sufficiently by the cruise ship industry or individual 
State or local health authorities. As described in the March 14, 2020, 
Order, as further modified and extended on April 15, 2020, July 16, 
2020, and September 30, 2020, cruise ship travel markedly increases the 
risk and impact of the COVID-19 disease epidemic within the United 
States. If unrestricted cruise ship passenger operations were permitted 
to resume, infected and exposed persons disembarking cruise ships would 
place federal partners (e.g., Customs and Border Protection and the 
U.S. Coast Guard), healthcare workers, port personnel, and communities 
at substantial unnecessary risk. Unrestricted cruise ship travel would 
also divert and overburden scarce federal, state, and local, public 
health and healthcare resources during a pandemic.
    The Director also continues to find evidence to support a 
reasonable belief that cruise ships are or may be infected or 
contaminated with a quarantinable communicable disease.\14\ This 
reasonable belief is based on information from epidemiologic and other 
data included in this document and the information described in the 
March 14, 2020, Order and the April 15, July 16, and September 30, 
2020, modifications and extensions. As a result, absent measures of the 
type needed to mitigate further transmission, persons on board or 
seeking to board cruise ships may likely be or would likely become 
infected with or exposed to COVID-19 by virtue of being on board at a 
time when cases of COVID-19 continue to be reported in increasingly 
significant numbers globally.\15\ Additionally, persons infected on 
cruise ships would be likely to transmit COVID-19 to U.S. communities 
by traveling interstate after cruising.
---------------------------------------------------------------------------

    \14\ COVID-19 is a communicable disease for which quarantine is 
authorized under Section 361 of the Public Health Service Act (42 
U.S.C. 264) and 42 CFR 70.1, 71.1, as listed in Executive Order 
13295, as amended by Executive Orders 13375 and 13674.
    \15\ Since the March 14, 2020, Order, the number of global cases 
of COVID-19 reported by the World Health Organization (WHO) has 
risen from 142,534 to more than 44 million as of October 30, 2020, 
with nearly 1.2 million deaths. See Situation Reports, WHO, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports.
---------------------------------------------------------------------------

    Accordingly, under 42 CFR 70.2, the Director determines that 
measures taken by State and local health authorities regarding COVID-19 
onboard cruise ships are inadequate to prevent the further interstate 
spread of the disease. Cruise ships by their very nature travel 
interstate and internationally and can move beyond the jurisdictional 
boundaries of any single state or local health authority. Furthermore, 
local transmission of COVID-19 onboard a cruise ship can escalate 
quickly into additional interstate and international transmission when 
infected persons travel. Therefore, federal intervention is needed to 
require public health measures to prevent the further introduction, 
transmission, or spread of COVID-19 via cruise ships globally and into 
U.S. communities.
    This Order is not a rule within the meaning of the Administrative 
Procedure Act (``APA''), but rather an emergency action taken under the 
existing authority of 42 CFR 70.2, 71.31(b), and 71.32(b). CDC 
published a Request for Information (RFI) in the Federal Register that 
solicited and

[[Page 70158]]

obtained public comment related to cruise ship planning and 
infrastructure, resumption of passenger operations, and additional 
summary questions (85 FR 44083). In the event that this Order qualifies 
as a rule under the APA, notice and comment and a delay in effective 
date are not required because CDC has already obtained public comment 
and good cause exists to dispense with prior public notice and the 
opportunity to further comment on this Order.\16\ Considering the 
public health emergency caused by COVID-19 based on, among other 
things, its potential for spread on board cruise ships, it would be 
impracticable and contrary to the public's health, and by extension the 
public's interest, to delay the issuance and effective date of this 
Order. Similarly, if this Order qualifies as a rule per the definition 
in the APA, the Office of Information and Regulatory Affairs has 
determined that it would be a major rule, but there would not be a 
delay in its effective date as the agency has invoked the good cause 
provision of the APA.
---------------------------------------------------------------------------

    \16\ See 5 U.S.C. 553(b)(B), (d)(3).
---------------------------------------------------------------------------

    If any provision in this Order, or the application of any provision 
to any carriers, persons, or circumstances, shall be held invalid, the 
remainder of the provisions, or the application of such provisions to 
any carriers, persons, or circumstances other than those to which it is 
held invalid, shall remain valid and in effect.
    In accordance with 42 U.S.C. 264(e), this Order shall supersede any 
provision under State law (including regulations and provisions 
established by political subdivisions of States), that conflict with an 
exercise of Federal authority, including instructions by U.S. Coast 
Guard or HHS/CDC personnel permitting ships to make port or disembark 
persons under stipulated conditions, under this Order.
    This Order shall be enforceable through the provisions of 18 U.S.C. 
3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR 70.18, 71.2.
    Therefore, in accordance with Sections 361 and 365 of the Public 
Health Service Act (42 U.S.C. 264, 268) and 42 CFR 70.2, 71.31(b), 
71.32(b), for all cruise ships described above for the period described 
below, it is ordered:

Framework for Conditional Sailing

Purpose and Scope
    (a) Purpose. The purpose of this framework is to prevent the 
further introduction, transmission, and spread of COVID-19 into and 
throughout the United States via cruise ships. These requirements are 
in addition to other requirements in regulations or actions taken by 
HHS/CDC to prevent the introduction, transmission, and spread of 
communicable diseases under 42 U.S.C. 264 and 42 CFR part 70 and 42 CFR 
part 71.
    (b) Scope. This framework applies to any person operating or 
intending to operate a cruise ship in U.S. waters and to any person 
operating a cruise ship outside of U.S. waters if the cruise ship 
operator intends for the ship to return to operating in U.S. waters 
while this Order remains in effect.
    (1) Upon request, cruise ship operators must make their properties 
and records available for inspection to allow CDC to ascertain 
compliance with this framework. Such properties and records include but 
are not limited to vessels, facilities, vehicles, equipment, 
communications, manifests, list of passengers, and employee and 
passenger health records.
    (2) CDC may enforce any of the provisions of this framework through 
additional orders published in the Federal Register and issue 
additional technical instructions as needed.
    (3) Nothing in this framework supersedes or preempts enforcement of 
emergency response requirements imposed by statutes or other 
regulations.
    (4) Cruise ship operators may use the services of professionally 
licensed and accredited third-party auditors to assist them in meeting 
the requirements of this framework. Notwithstanding, the cruise ship 
operator's responsible officials maintain an overall duty and 
responsibility for meeting the requirements of this framework, 
including the requirements of any technical instructions or orders. 
Third-party auditors are prohibited from interfering with CDC's ability 
to inspect and conduct oversight under this framework, including but 
not limited to interfering with CDC's ability to interview cruise ship 
crew and personnel or visually inspect and oversee collection of 
laboratory specimens and laboratory testing.
Requirements for Protection of Crew for Cruise Ship Operators Operating 
or Intending To Operate Cruise Ships in U.S. Waters
    (a) A cruise ship operator subject to this Order must meet the 
requirements of this framework as a condition of obtaining or retaining 
controlled free pratique for operating a cruise ship in U.S. waters or 
if the cruise ship operator is operating a cruise ship outside of U.S. 
waters and intends for the ship to return to operating in U.S. waters 
while this Order remains in effect. These requirements must 
additionally be met as a condition of obtaining or retaining controlled 
free pratique for conducting a simulated voyage or applying for a 
COVID-19 Conditional Sailing Certificate.
    (1) The cruise ship operator must have received a determination by 
CDC that a plan submitted in response to the No Sail Order and 
Suspension of Further Embarkation; Notice of Modification and Extension 
and Other Measures Related to Operations published at 85 FR 21004 
(April 15, 2020) (i.e., ``No Sail Order response plan''), as modified 
and extended July 16, 2020 (published at 85 FR 44085 (July 21, 2020)), 
and September 30, 2020 (published at 85 FR 62732 (October 5, 2020)) is 
complete and accurate, including having submitted to CDC a signed 
Acknowledgment of No Sail Order Response Plan Completeness and 
Accuracy.
    (2) Cruise ships operating in U.S. waters must continue to submit 
the EDC form as specified in CDC technical instructions or orders. 
Cruise ship operators with ships that have not been in U.S. waters 
during the period of March 14 through October 31, 2020, or who 
voluntarily withdrew their ships during this time period, and who wish 
to operate those ships in U.S. waters during the period that this 
framework remains in effect, must additionally submit the EDC form 
during (at a minimum) the 28 days preceding those ships' expected 
arrival in U.S. waters and continue to submit the EDC form after the 
ships' entering U.S. waters.
    (3) The cruise ship operator has observed and will continue to 
observe all elements of its No Sail Order response plan including by 
following the most current CDC recommendations and guidance for any 
public health actions related to COVID-19, or if any deviations from 
the plan have occurred such deviations have been reported and 
corrective actions taken to the satisfaction of CDC.
    (4) The cruise ship operator has arranged for and submitted and 
will continue to arrange for and submit such laboratory test results as 
may be required by CDC for every crew member on board ships operating 
in U.S. waters and/or operating outside of U.S. waters if the cruise 
ship operator intends for the ship to return to operating in U.S. 
waters at any time while this Order remains in effect. Laboratory 
testing for every crew member must be conducted on a weekly basis or at 
such other intervals as required by CDC in technical instructions or 
orders. CDC may conduct oversight of specimen

[[Page 70159]]

collection, testing, and laboratory procedures, as necessary.
    (5) If the cruise ship received any ship-to-ship transfers in the 
last 28 days, crew were only transferred from a cruise ship with no 
confirmed COVID-19 or COVID-like illness during the 28 days before the 
transfer occurred.
    (6) If the cruise ship received any land-based embarking crew, such 
crew were laboratory tested for COVID-19 upon embarkation and 
quarantined per CDC technical instructions or orders immediately upon 
embarking the ship.
    (7) Following submission of an application for a COVID-19 
Conditional Sailing Certificate, the cruise ship operator shall 
continue to follow these requirements for protection of crew pending 
approval of the operator's application.
    (b) CDC may issue additional requirements through technical 
instructions or orders relating to a cruise ship operator's processes 
and procedures for protection of crew.
General Prohibition on a Cruise Ship Operator Commencing or Continuing 
Passenger Operations Without a COVID-19 Conditional Sailing Certificate
    (a) A cruise ship operator shall not commence or continue any 
passenger operations in U.S. waters without a COVID-19 Conditional 
Sailing Certificate issued by CDC that meets the requirements in this 
framework for each cruise ship that the cruise ship operator intends to 
operate with passengers in U.S. waters.
    (b) A cruise ship operator shall not violate the terms or 
conditions of a COVID-19 Conditional Sailing Certificate issued 
pursuant to this framework.
    (c) As a condition of obtaining or retaining a COVID-19 Conditional 
Sailing Certificate, the cruise ship operator must be in compliance 
with CDC's standards for mitigating the risk of COVID-19 onboard the 
cruise ship as set forth in this framework and in CDC technical 
instructions or orders.
Agreement With Port and Local Health Authorities
    (a) As a condition of obtaining or retaining controlled free 
pratique for conducting a simulated voyage or obtaining and retaining a 
COVID-19 Conditional Sailing Certificate, a cruise ship operator must 
document the approval of all U.S. port and local health authorities 
where the ship intends to dock or make port during a simulated voyage 
or a restricted passenger voyage. Such written approval must include 
the following:
    (1) A medical care agreement between the cruise ship operator and 
health care entities, addressing evacuation to onshore hospitals for 
passengers and crew in need of care, in accordance with CDC technical 
instructions and orders.
    (2) A housing agreement between the cruise ship operator and one or 
more shoreside facilities for isolation and quarantine of COVID-19 
cases and close contacts, respectively, identified from the day of 
embarkation through disembarkation for each voyage, in accordance with 
CDC technical instructions and orders.
    (3) A port agreement between the cruise ship operator and port 
authority to determine the number of cruise ships at any single port in 
order to not overburden the public health response resources of any 
single jurisdiction in the event of a COVID-19 outbreak.
Minimum Standards for Simulated Voyages Prior to Issuance of COVID-19 
Conditional Sailing Certificate
    (a) As a condition of applying for a COVID-19 Conditional Sailing 
Certificate, a cruise ship operator must have successfully conducted a 
simulated voyage or series of simulated voyages demonstrating the 
cruise ship operator's ability to mitigate the risks of COVID-19 
onboard its cruise ship. A simulated voyage must meet the following 
requirements:
    (1) The cruise ship operators shall inform volunteer passengers in 
writing that they are participating in a simulation of unproven and 
untested health and safety protocols for purposes of simulating a 
cruise ship voyage and that sailing during a pandemic is an inherently 
risky activity.
    (2) All volunteer passengers must be at least eighteen years old or 
older. The cruise ship operator must also obtain from all volunteer 
passengers a written certification from a healthcare provider that the 
volunteer passenger has no pre-existing medical conditions that would 
place that individual at high risk for COVID-19 as determined through 
CDC guidance. CDC may issue additional requirements through technical 
instructions or orders relating to a cruise ship operator's obligation 
to screen for volunteer passengers who may be at high risk for COVID-
19.
    (3) The cruise ship operator must conduct any simulation on a 
consensual basis and not as a condition of employment or in exchange 
for consideration or future reward. The cruise ship operator must 
document the informed consent of all participants in writing.
    (4) The cruise ship operator must embark additional crew members 
beyond safe minimum manning levels only as determined through CDC 
technical instructions or orders.
    (5) The cruise ship operator must design and conduct a simulated 
voyage insofar as practicable to test the efficacy of the cruise ship 
operator's ability to mitigate the risks of COVID-19 onboard its cruise 
ship.
    (6) The cruise ship operator must conduct a monitored observation 
period and laboratory testing of volunteer passengers, as directed in 
CDC technical instructions or orders, prior to embarking volunteer 
passengers on a simulated voyage.
    (7) A simulated voyage must include the following simulated 
activities:
    (i) Embarkation and disembarkation procedures, including terminal 
check-in,
    (ii) on board activities, including at dining and entertainment 
venues,
    (iii) private island shore excursions, if any are planned during 
restricted passenger voyages,
    (iv) evacuation procedures,
    (v) transfer of symptomatic passengers or crew, or those who test 
positive for SARS-CoV-2, from cabins to isolation rooms,
    (vi) quarantine of all remaining passengers and non-essential crew, 
and
    (vii) other activities as may be listed in CDC technical 
instructions and orders.
    (8) The cruise ship operator must meet standards for hand hygiene, 
face coverings, and social distancing for passengers and crew, as well 
as ship sanitation, as may be required by CDC technical instructions or 
orders.
    (9) The cruise ship operator must modify meal service and 
entertainment venues to facilitate social distancing during the 
simulated voyage.
    (10) The cruise ship operator must 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. 
Laboratory test results must be available prior to passengers embarking 
and prior to passengers and crew departing for their final destinations 
after disembarking the ship. Crew and passengers must also be 
laboratory tested again post-disembarkation as required by CDC 
technical instructions or orders. Based on public health 
considerations, CDC may also require additional laboratory testing of 
passengers and crew and reporting of results, including during a 
voyage, as required by CDC technical instructions or orders.
    (11) The cruise ship operator must immediately conduct laboratory 
testing

[[Page 70160]]

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. Identified close 
contacts of cases must also be laboratory tested with rapid point of 
care results.
    (12) 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 COVID-19 is detected during 
the simulation.
    (13) The cruise ship operator must document any deficiencies in its 
health and safety protocols through an ``after-action'' report and 
address how the cruise ship operator intends to address those 
deficiencies prior to applying for a COVID-19 Conditional Sailing 
Certificate. This after-action report must also include 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.
    (14) Based on CDC's review of the after-action report and/or cruise 
ship operator's application for a COVID-19 Conditional Sailing 
Certificate, CDC may request that the cruise ship operator modify its 
practices or procedures and/or engage in additional simulated voyages 
prior to the issuance of the COVID-19 Conditional Sailing Certificate.
    (b) Prior to conducting a simulated voyage in accordance with this 
section, the cruise ship operator shall provide written notice and 
request CDC's approval to conduct the simulation. Such written notice 
must be provided prior to the simulation and specify the time, 
location, contact information for all individuals or parties involved, 
and protocols or practices to be simulated.\17\
---------------------------------------------------------------------------

    \17\ This written notice should be submitted at least 30 
calendar days prior to the date on which the cruise ship operator 
proposes to conduct the simulation.
---------------------------------------------------------------------------

    (c) A cruise ship operator shall not apply for approval to conduct 
a simulated voyage until all of CDC's requirements relating to the 
protection of crew onboard ships in U.S. waters have been satisfied. 
The cruise ship operator's responsible officials must sign the 
application for permission to conduct a simulation and certify under 18 
U.S.C. 1001 that all of CDC's requirements relating to the protection 
of crew onboard cruise ships in U.S. waters have been satisfied.
    (d) CDC will respond to the written notice and request for approval 
to conduct a simulation in writing in a timely manner. CDC may deny the 
request to conduct a simulation if the cruise ship operator is not in 
compliance with any provision of this framework, technical 
instructions, or orders, or if in CDC's determination the simulation 
does not provide adequate safeguards to minimize the risk of COVID-19 
for all participants.
    (e) CDC may conduct such oversight and inspection of simulated 
voyages as it deems necessary in its discretion, including through in-
person or remote means allowing for visual observation.
    (f) CDC may issue additional requirements through technical 
instructions or orders relating to a cruise ship operator's processes 
and procedures for conducting and evaluating a simulated voyage prior 
to applying for a COVID-19 Conditional Sailing Certificate.
Applying for a COVID-19 Conditional Sailing Certificate
    (a) A cruise ship operator must submit the following to CDC prior 
to commencing restricted passenger operations: \18\
---------------------------------------------------------------------------

    \18\ These materials should be submitted at least 60 calendar 
days prior to the date on which the cruise ship operator proposes to 
commence restricted passenger operations.
---------------------------------------------------------------------------

    (1) A completed CDC registration/application form that must include 
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 and of any third-party auditors.
    (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 copy of the USCG Certificate of Inspection issued in 
accordance with 46 CFR 2.01-5 that was in effect for the six months 
preceding the application.
    (5) A certification statement signed under 18 U.S.C. 1001 by the 
responsible officials attesting that the cruise ship operator has 
complied and remains in compliance with CDC's crew protection 
requirements of prior to applying for a COVID-19 Conditional Sailing 
Certificate.
    (6) A certification statement signed under 18 U.S.C. 1001 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.
    (7) A certification statement signed under 18 U.S.C. 1001 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.
    (8) A certification statement signed under 18 U.S.C. 1001 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.
Review of an Application for a COVID-19 Conditional Sailing Certificate
    (a) Upon receiving the documentation required by this framework, 
CDC will review the application for completeness. Based on CDC's 
determination as to whether the cruise ship operator has met CDC's 
standards for mitigating the risk of COVID-19 onboard the cruise ship 
for which the operator intends to commence restricted passenger 
operations, it shall grant or deny the application. If CDC requires 
additional information to ascertain whether the cruise ship operator 
has met CDC's standards for mitigating the risk of COVID-19 on board 
cruise ships, or if it determines the application to be incomplete, it 
may hold the application in abeyance pending the submission of such 
additional information as required by CDC to make such a determination. 
Applications that are denied may be administratively appealed as 
described in this framework.
    (b) CDC may limit the terms or conditions of a cruise ship 
operator's COVID-19 Conditional Sailing Certificate in regard to 
passenger or crew capacity, itinerary, ports of call, length of voyage, 
onboard or shoreside activities, or in regard to any other passenger, 
crew, or cruise ship operations, as needed to the health and safety of 
passengers and crew or the public's health.
    (c) As a condition of obtaining or retaining a COVID-19 Conditional 
Sailing Certificate, the cruise ship operator must upon request make 
its

[[Page 70161]]

properties and records available for inspection to allow CDC to 
ascertain compliance with this framework. Such properties and records 
include but are not limited to vessels, facilities, vehicles, 
equipment, communications, manifests, list of passengers, and employee 
and passenger health records. The cruise ship operator must also make 
any crew member or other personnel involved in the operation of a 
cruise ship available for interview by CDC.
    (d) As a condition of obtaining or retaining a COVID-19 Conditional 
Sailing Certificate, CDC may require a cruise ship operator to submit 
proof of having been inspected by any other agency or entity with 
authority, jurisdiction, or oversight over any aspect of a cruise ship 
operator's operations.
    (e) As a condition of obtaining or retaining a COVID-19 Conditional 
Sailing Certificate, cruise ship operators must establish mechanisms to 
ensure compliance, including reporting mechanisms to notify CDC and 
USCG in writing within 24 hours of the occurrence of any deviations, 
whether intentional, or as a result of error or omission, and take 
corrective steps to rectify those deviations.
    (f) As a condition of obtaining or retaining a COVID-19 Conditional 
Sailing Certificate, cruise ship operators must comply with the 
requirements of this framework. These requirements apply to any cruise 
ship operating in U.S. waters and to cruise ships operating outside of 
U.S. waters if the cruise ship operator intends for the ship to return 
to operating in U.S. waters at any time while Order remains in effect.
Amendment or Modification of COVID-19 Conditional Sailing Certificate
    (a) A cruise ship operator may seek to amend or modify a COVID-19 
Conditional Sailing Certificate issued under this framework by 
submitting such amendment or modification to CDC for review and a 
determination in accordance with this section.
    (b) CDC will review the cruise ship operator's request to amend or 
modify a COVID-19 Conditional Sailing Certificate and either grant or 
deny the request in writing. If CDC requires additional information to 
ascertain whether the cruise ship operator's proposed amendment or 
modification meets CDC's standards for mitigating the risk of COVID-19 
on board cruise ships, or if it determines the request to be 
incomplete, it may hold the request in abeyance pending the submission 
of such additional information as required by CDC to make such a 
determination.
    (c) CDC may require any cruise ship operator to amend or modify a 
COVID-19 Conditional Sailing Certificate based on public health 
considerations specific to the cruise ship, cruise ship operator, or 
affecting the health or safety of cruise travel as a whole.
    (d) Denials of requests to amend or modify a COVID-19 Conditional 
Sailing Certificate are subject to administrative review as described 
in this framework.
Minimum Standards for Restricted Passenger Voyages as a Condition of 
Obtaining and Retaining a COVID-19 Conditional Sailing Certificate
    (a) As a condition of obtaining and retaining a COVID-19 
Conditional Sailing Certificate, a cruise ship operator must meet the 
following minimum standards:
    (1) The cruise ship operator must in marketing materials, on its 
website, and in offerings for voyages, notify prospective passengers 
prior to accepting a reservation of any CDC travel advisory, warning, 
or recommendation relating to cruise travel. Such notification must 
further advise prospective passengers that, if a threshold of COVID-19 
is detected on board the cruise ship during a voyage, the voyage will 
be ended immediately and the ship returned to the U.S. port of 
embarkation, and their subsequent travel, including their return home, 
may be restricted or delayed.
    (2) The cruise ship operator must not sail or offer to sail on an 
itinerary longer than 7 days. CDC may shorten or lengthen the number of 
days permitted to sail based on public health considerations and as set 
forth in technical instructions or orders.
    (3) The cruise ship operator must screen passengers and crew before 
they embark for signs and symptoms or known exposure to COVID-19 and 
deny boarding to anyone who is suspected of having COVID-19 or is an 
identified contact of a confirmed or suspected case, in accordance with 
CDC technical instructions or orders.
    (4) The cruise ship operator must conduct laboratory testing of all 
passengers and crew on the day of embarkation and the day of 
disembarkation in accordance with CDC technical instructions or orders. 
Laboratory test results must be available prior to passengers embarking 
and prior to passengers and crew departing for their final destinations 
after disembarking the ship.
    (5) The cruise ship operator must immediately conduct laboratory 
testing of any passengers and crew who report illness consistent with 
COVID-19 during the voyage with rapid point of care results as required 
by CDC technical instructions or orders. Identified close contacts of 
cases must also be laboratory tested with rapid point of care results.
    (6) The cruise ship operator shall report syndromic surveillance 
and all laboratory test results using CDC's EDC form as required by CDC 
technical instructions or orders.
    (7) The cruise ship operator must meet standards for hand hygiene, 
face coverings, and social distancing for passengers and crew, as well 
as ship sanitation, as required by CDC technical instructions or 
orders.
    (8) The cruise ship operator must modify meal service and 
entertainment venues to facilitate social distancing.
    (b) In light of public health considerations and based on evidence 
gained through review and evaluation of cruise operators' practices and 
procedures, including through simulated voyages, CDC may require the 
following:
    (1) A monitored observation period of passengers prior to 
embarking.
    (2) Post day of disembarkation laboratory testing of passengers and 
crew.
    (3) Additional laboratory testing of passengers and crew and 
reporting of results during a voyage.
    (c) CDC may issue additional technical instructions or orders 
regarding health and safety standards for restricted passenger voyages.
Minimum Standards for Management of Passengers and Crew From COVID-19-
Affected Cruise Ships for Restricted Passenger Voyages
    (a) Based on a threshold of COVID-19 being detected in passengers 
or crew, as determined through CDC technical instructions or orders, a 
cruise ship operator must immediately take the following actions:
    (1) Conduct such notifications of passengers, crew members, and 
other government entities as CDC may require.
    (2) Immediately end the restricted passenger voyage, cancel future 
restricted passenger voyages until directed by CDC that such voyages 
may resume, and return the ship to the U.S. port of embarkation.
    (3) Immediately isolate any sick or infected passengers and crew in 
single occupancy cabins with private bathrooms and quarantine all 
remaining passengers and non-essential crew.
    (4) Disembark and evacuate passengers and crew only in such a 
manner as prescribed in the cruise ship operator's preexisting port and 
local health authority agreements.

[[Page 70162]]

    (5) Arrange to disembark and transport passengers and crew using 
noncommercial transportation or other transportation in accordance with 
CDC's technical instructions and orders.
    (6) Instruct disembarking passengers and crew to stay home and 
continue to practice social distancing after reaching their final 
destination as per CDC technical instructions or orders.
    (7) Inform ship pilots, ground transportation, air charter 
operators, and other agencies with relevant jurisdiction that COVID-19 
has been detected in passengers or crew and confirm that the operators 
have plans in place to notify and protect the health and safety of 
their staff (e.g., drivers, air crews).
    (b) CDC may issue additional technical instructions or orders 
regarding what measures cruise ship operators must take in the event 
that COVID-19 is detected in passengers or crew.
Denials, Suspension, Revocation, and Reinstatement of a Cruise Ship 
Operator's COVID-19 Conditional Sailing Certificate
    (a) CDC may deny an application for a COVID-19 Conditional Sailing 
Certificate, or revoke, or suspend a COVID-19 Conditional Sailing 
Certificate if:
    (1) The cruise ship operator is not in compliance with CDC's 
standards for mitigating the risk of COVID-19 on board cruise ships; or
    (2) the cruise ship operator is not in compliance with the terms of 
its COVID-19 Conditional Sailing Certificate; or
    (3) necessary to protect human health or safety based on public 
health considerations specific to the particular cruise ship operator, 
cruise ship, or affecting cruise travel as a whole.
    (b) CDC may reinstate a suspended or revoked COVID-19 Conditional 
Sailing Certificate after:
    (1) Inspecting the cruise ship operator's properties and records, 
including, but are not limited to, its vessels, facilities, vehicles, 
equipment, communications, manifests, list of passengers, and employee 
and passenger health records;
    (2) conferring with the cruise ship operator, responsible 
officials, third-party auditors, or other persons under the cruise ship 
operator's employ; and
    (3) receiving information and written assurances from the cruise 
ship operator and/or its responsible officials that any deficiencies 
have been rectified and actions taken to ensure future compliance.
Administrative Review
    (a) A cruise ship operator may appeal a denial of its application 
for a COVID-19 Conditional Sailing Certificate or a revocation or 
suspension of its COVID-19 Conditional Sailing Certificate based on 
specific factors particular to that operator.
    (b) The cruise ship operator's appeal must be in writing, state the 
factual basis for the appeal, and be submitted to the CDC Director 
within 30 calendar days of the decision.
    (c) The CDC Director's decision will be issued in writing and will 
constitute final agency action. Prior to deciding upon an appeal, the 
Director may further investigate the reasons for the denial, 
revocation, or suspension, including by conferring with the cruise ship 
operator, responsible officials, third-party auditors, or other persons 
under the cruise ship operator's employ.

Initial Phase COVID-19 Testing Requirements for Protection of Crew

    CDC will take a phased approach to resuming passenger operations 
onboard cruise ships and considers adequate crew safeguards an integral 
part of its initial phases. Accordingly, it is further ordered:
Shoreside COVID-19 Laboratory Screening Testing of All Crew
    (1) Within 60 days of the effective date of this Order,\19\ cruise 
ship operators must collect clinical specimens from all crew currently 
onboard their cruise ships and have those specimens immediately 
transported and tested by a shoreside laboratory facility. This testing 
must be conducted by a Clinical Laboratory Improvement Amendments 
(CLIA)-certified laboratory using reverse transcriptase polymerase 
chain reaction (RT-PCR) tests that are approved, cleared, or authorized 
for emergency use by the U.S. Food and Drug Administration (FDA).
---------------------------------------------------------------------------

    \19\ For cruise ship operators with ships that have not been in 
U.S. waters during the period of the No Sail Order or voluntarily 
withdrew their ships, the 60-day period will begin upon: (1) CDC 
confirming to the cruise ship operator in writing that the operator 
has a complete and accurate NSO response plan, including having 
submitted to CDC a signed Acknowledgment of No Sail Order Response 
Plan Completeness and Accuracy; and (2) submission of the EDC form 
for the 28 days preceding the cruise ship's expected arrival in U.S. 
waters.
---------------------------------------------------------------------------

    (2) To help ensure the validity of sampling, testing, and test 
results, cruise ship operators must contact CDC at [email protected] 
at least 7 calendar days prior to collecting specimens and conducting 
testing. CDC must approve the cruise ship operator's selection of a 
CLIA-certified laboratory and the cruise ship operator's procurement of 
specimen collection kits. Include ``Laboratory Screening Testing of All 
Crew Onboard SHIP NAME'' in the subject line as part of your request 
for CDC approval.
    (3) CDC's response to the cruise ship operator's email may include 
additional information regarding best practices that may assist cruise 
ship clinicians or public health staff in collecting and transporting 
crew specimens. CDC may also oversee the onboard collection of crew 
specimens through remote means allowing for visual observation.
    (4) Cruise ship operators must report all laboratory results in 
aggregate to CDC through the Enhanced Data Collection (EDC) form.
Onboard COVID-19 Diagnostic Testing Capabilities for Symptomatic 
Travelers (Crew and Future Passengers)
    (1) During this 60-day period, cruise ship operators in 
coordination with CDC must develop onboard testing capabilities to test 
all symptomatic travelers (crew and future passengers) for COVID-19 and 
close contacts. After this 60-day period, laboratory testing for every 
crew member must be conducted on a weekly basis or at such other 
intervals as required by CDC in technical instructions or orders.
    (2) All cruise ships must procure rapid RT-PCR point-of-care 
equipment to test symptomatic travelers. This instrument must be CLIA-
waived and have been evaluated on the FDA reference panel for SARS-CoV-
2 and demonstrated a lower limit of detection correlating to higher 
sensitivity. Cruise ship operators must contact CDC prior to procuring 
this equipment. Antigen testing is not recommended at this time because 
it is more likely to miss cases of SARS-CoV-2 infection (i.e., lower 
sensitivity) when compared to RT-PCR testing.
    (3) Cruise ship medical clinic staff must be competent in specimen 
collection, be able to properly use testing equipment, follow all 
manufacturer's instructions, and have access to and use recommended 
personal protective equipment (PPE) for specimen collection and 
handling. CDC may ensure competency by conducting oversight of these 
practices through remote means allowing for visual observation. In 
addition, cruise ship operators must maintain onboard SARS-CoV-2 
testing equipment to manufacturer's specifications.
    (4) Once testing equipment has been obtained and cruise ship 
medical clinic staff are properly trained in its use, all symptomatic 
crew onboard the cruise ship must be tested for SARS-CoV-2

[[Page 70163]]

infection immediately upon notifying medical staff of symptom onset. 
These results must be reported to CDC in aggregate through the EDC 
form.
Shoreside COVID-19 Laboratory Screening Testing of All Embarking Crew
    (1) On the day of crew members' embarkation, cruise ship operators 
must collect specimens for SARS-CoV-2 testing from all embarking land-
based crew. Cruise ship operators must immediately transport the 
specimens to a CLIA-certified laboratory for testing.
    (2) This laboratory must use an RT-PCR test that has been approved, 
cleared, or authorized for emergency use by FDA. Cruise ship operators 
must report results in aggregate to CDC through the EDC form. CDC must 
approve the cruise ship operator's selection of a CLIA-certified 
laboratory.
    (3) All embarking land-based crew must be immediately quarantined 
onboard for 14 days. Those who test positive must be isolated until 
criteria are met for discontinuation of isolation according to the most 
current CDC guidance. CDC may also oversee the collection of specimens, 
or the quarantine or isolation of embarking crew, through remote means 
allowing for visual observation.
Continued Compliance With No Sail Order (NSO) Response Plans
    (1) Cruise ship operators must continue to follow their cruise 
lines' complete, accurate, and acknowledged NSO response plans per the 
No Sail Order and Suspension of Further Embarkation; Notice of 
Modification and Extension and Other Measures Related to Operations 
published at 85 FR 21004 (April 15, 2020) (i.e., ``No Sail Order 
response plan''), as modified and extended July 16, 2020 (published at 
85 FR 44085 (July 21, 2020)), and September 30, 2020 (published at 85 
FR 62732 (October 5, 2020)).
    (2) Cruise ship operators must also continue to follow CDC's 
Interim Guidance for Mitigation of COVID-19 Among Cruise Ship Crew and 
COVID-19 Color-coding System for Cruise Ships, which may be modified or 
updated as needed. CDC will notify cruise ship operators of any 
updates. Ship-to-ship crew transfers and embarkations may continue to 
impact ships' color-coding status. For additional information about 
other public health preventive measures, such as social distancing, 
mask use, and cabin occupancy, refer to CDC's Interim Guidance.

Effective Date and Signature

    This Order is effective upon signature and shall remain in effect 
until the earliest of (1) the expiration of the Secretary of Health and 
Human Services' declaration that COVID-19 constitutes a public health 
emergency; (2) the CDC Director rescinds or modifies the order based on 
specific public health or other considerations; or (3) November 1, 
2021.

    Authority:  The authority for these orders is Sections 361 and 
365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 CFR 
70.2, 71.31(b), 71.32(b).

    Dated: October 30, 2020.
Nina B. Witkofsky,
Acting Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2020-24477 Filed 10-30-20; 4:15 pm]
BILLING CODE 4163-18-P