[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62732-62739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


No Sail Order and Suspension of Further Embarkation; Third 
Modification and Extension of No Sail Order and Other Measures Related 
to Operations

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 U.S. Department of Health and Human Services (HHS), 
announces a third modification and extension of the No Sail Order and 
Other Measures Related to Operations that was issued on July 16, 2020. 
This Order applies to cruise ships defined as commercial, non-cargo, 
passenger-carrying vessels with the capacity to carry 250 or more 
individuals (passengers and crew) and with an itinerary anticipating an 
overnight stay onboard or a 24-hour stay onboard for either passengers 
or crew, that are operating in international, interstate, or intrastate 
waterways, subject to the jurisdiction of the United States. This Order 
shall additionally apply to cruise ships operating outside of U.S. 
waters if the cruise ship operator intends for the ship to return to 
operating in international, interstate, or intrastate waterways, 
subject to the jurisdiction of the United States during the period that 
this Order is in effect.

DATES: This action was effective September 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 V18-2, Atlanta, GA 30329. Phone: 404-498-1600. 
Email: [email protected].

SUPPLEMENTARY INFORMATION: This Order renews the No Sail Order and 
Other Measures Related to Operations signed by the CDC Director on 
March 14, 2020, as further modified and extended effective April 15, 
2020, and July 16, 2020 subject to the modifications and additional 
stipulated conditions as set forth in this Order.
    This Order 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) October 31, 2020.
    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/index.html.

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):

Third Modification and Extension of No Sail Order and Other Measures 
Related to Operations

Executive Summary

    The coronavirus disease 2019 (COVID-19) pandemic continues to 
spread rapidly around the world with no approved treatment or vaccine. 
By July 16, 2020, the date of the second modification and extension of 
the No Sail Order, there were over 13 million confirmed cases and over 
580,000 confirmed deaths worldwide. As of September 28, 2020, a 
cumulative total of over 33 million cases and almost 1 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 September 28, 
2020, there have been over 7 million cases and more than 200,000 
confirmed deaths with over 300,000 new cases reported in the last 7 
days.
    Since HHS/CDC's original No Sail Order, signed on March 14, 2020, 
which suspended the embarkation of passengers, CDC has worked to 
control the spread of the virus associated with COVID-19 on cruise 
ships that remained in U.S. jurisdiction, while protecting against 
further introduction and spread of the virus associated with COVID-19 
into U.S. communities. Cruise ships continue to be an unsafe 
environment with close quarters where the disease spreads easily and is 
not readily detected.
    Cumulative CDC data from March 1 through September 28, 2020, show a 
total of 3,689 confirmed cases of COVID-19 \1\ or COVID-like illness 
\2\ cases on cruise ships and 41 deaths. These data have also revealed 
a total of 102 outbreaks on 124 different cruise ships, meaning more 
than 82% of ships within U.S. jurisdiction were affected by COVID-19 
during this time frame. In addition, four cruise ships still have 
ongoing or resolving COVID-19 outbreaks on board. Recent outbreaks on 
cruise ships overseas continue to demonstrate that reduced capacity 
alone has not diminished transmission.
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    \1\ Confirmed COVID-19 means laboratory confirmation for 
presence of SARS-CoV-2, the virus that causes COVID-19, by 
polymerase chain reaction (PCR) testing.
    \2\ COVID-like illness means acute respiratory illness (ARI), 
influenza-like illness (ILI), or diagnosis of pneumonia.
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    The challenges described in this document highlight the need for 
further action prior to cruise ships safely resuming passenger 
operations in the United States. CDC supports the decision by the 
Cruise Line International Association (CLIA) and its members to 
voluntarily extend the suspension of operations for passenger cruise 
ship travel through October 31, 2020.\3\ CDC further supports the 
decisions of numerous cruise ship operators that have voluntarily 
canceled scheduled voyages involving U.S. ports beyond the date 
specified by CLIA, including Cunard,\4\ Crystal Cruises,\5\

[[Page 62733]]

Holland America,\6\ Oceania Cruises,\7\ Princess Cruise Lines,\8\ 
Viking Ocean Cruises,\9\ and Windstar Cruises.\10\
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    \3\ Press Release, CLIA and Its Ocean-Going Cruise Line Members 
Announce Third Voluntary Suspension of U.S. Operations, https://cruising.org/en/news-and-research/press-room/2020/august/clia-announces-third-voluntary-suspension-of-us-cruise-operations Last 
accessed September 30, 2020.
    \4\ Cunard Extends Pause in Operations, https://www.cunard.com/en-us/contact-us/press-releases Last accessed September 30, 2020.
    \5\ https://www.crystalcruises.com/advisory-alerts/voyage-cancellations. Last accessed September 30, 2020.
    \6\ Press Release, Holland America Line Extends Its Pause Of 
Cruise Operations To All Departures Through Dec. 15, 2020, https://www.hollandamerica.com/en_US/news/2020-press-releases/news-08112020-FurtherPauseAug11_Dec1520.html Last accessed September 30, 2020.
    \7\ https://www.oceaniacruises.com/coronavirus-statement. Last 
accessed September 30, 2020.
    \8\ Princess Cruises Extends Pause of Select Global Ship 
Operations Until December 15, https://www.princess.com/news/notices_and_advisories/notices/global-ship-operations-pause-december-2020.html. Last accessed September 30, 2020.
    \9\ A letter from Chairman Torstein Hagen--August 12, 2020, 
https://www.vikingcruises.com/oceans/my-trip/current-sailings/index.html Last accessed September 30, 2020.
    \10\ Windstar Cruises Travel Advisory--August 27, 2020, https://www.windstarcruises.com/travel-health-advisory/ Last accessed 
September 30, 2020.
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    However, because not all cruise ship operators subject to the No 
Sail Order are members of CLIA or have made similar commitments, CDC is 
extending its No Sail Order to continue to protect the public's health 
by ensuring that passenger operations do not resume prematurely.

Previous Orders and Incorporation by Reference

    This Order renews the No Sail Order and Other Measures Related to 
Operations signed by the CDC Director on March 14, 2020,\11\ as further 
modified and extended effective April 15, 2020,\12\ and July 16, 2020 
\13\--subject to the modifications and additional stipulated conditions 
as set forth in this Order.
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    \11\ 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 
September 29, 2020.
    \12\ 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 
September 29, 2020.
    \13\ No Sail Order and Suspension of Further Embarkation. 
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 September 29, 
2020.
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    This Order 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) October 31, 2020.
    The findings and other evidence relied upon in issuing the March 14 
Order, and April 15 and July 16, 2020, modifications and extensions, 
are incorporated herein by reference. Any ambiguity or conflict between 
the March 14 Order, and April 15 and July 16 modifications and 
extensions, as further modified and extended by the current Order, 
shall be resolved in favor of the current Order.

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

Definitions

    The following definitions shall apply for the purposes of this 
Order:
    ``COVID-19'' means coronavirus disease 2019, the disease caused by 
the coronavirus SARS-CoV-2.
    ``Itinerary'' means a plan to engage in operations.
    ``Layup'' means reducing cruise ship operations to those levels 
needed to maintain essential machinery and equipment so that the ship 
may be returned to service at some future date.
    ``Operations,'' ``Operate,'' and ``Operating'' in U.S. waters mean 
any action by a cruise ship operator (e.g., shifting berths, moving to 
anchor, discharging waste, making port, or embarking or disembarking 
passengers or crew) to bring or cause a cruise ship to be brought into 
or transit in or between any international, interstate, or intrastate 
waterways, that are subject to the jurisdiction of the United States, 
or maintaining a ship in layup status in waters that are subject to the 
jurisdiction of the United States.
    ``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 be either the 
cruise ship captain or the cruise line to which the cruise ship 
belongs, or both. The term ``Operator'' as used in this Order further 
incorporates the terms ``company,'' ``designated person,'' and 
``responsible person'' as defined in 33 CFR 96.120.

Applicability

    This Modification and Extension of No Sail Order and Other Measures 
Related to Operations shall apply only to the subset of carriers \14\ 
described below and hereinafter referred to as ``cruise ships'':
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    \14\ Carrier is defined by 42 CFR 71.1 to mean, ``a ship, 
aircraft, train, road vehicle, or other means of transport, 
including military.''
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    All commercial, non-cargo,\15\ passenger-carrying vessels with the 
capacity \16\ to carry 250 \17\ or more individuals (passengers and 
crew) and with an itinerary anticipating an overnight stay onboard or a 
twenty-four (24) hour stay onboard for either passengers or crew that 
are operating \18\ in international, interstate, or intrastate 
waterways that are subject to the jurisdiction of the United 
States.\19\
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    \15\ Given the substantial risk of person-to-person transmission 
of COVID-19, as opposed to transmission via indirect contact, this 
Order is currently limited to passenger, non-cargo vessels.
    \16\ A ship's capacity shall be determined based on the number 
of persons listed in the U.S. Coast Guard Certificate of Inspection 
issued in accordance with 46 CFR 2.01-5 and that was in effect on 
July 16, 2020.
    \17\ Based on substantial epidemiologic evidence related to 
congregate settings and mass gatherings, this Order suspends 
operation of vessels with the capacity to carry 250 individuals or 
more. Evidence shows that settings as small as nursing homes or 
movie theaters can proliferate the spread of a communicable disease. 
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. In light of the demonstrated 
rapid spread of COVID-19 in cruise ship settings, application of 
this Order to vessels carrying 250 or more individuals is a prudent 
and warranted public health measure.
    \18\ This Order does not apply to cruise ships that were in 
layup prior to March 14, 2020 and have continuously remained in lay-
up status since that date.
    \19\ This Order shall not apply to vessels operated by a U.S. 
Federal or State government agency. Nor shall it apply to vessels 
being operated solely for purposes of the provision of essential 
services, such as the provision of medical care, emergency response, 
activities related to public health and welfare, or government 
services, such as food, water, and electricity.
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    This Order shall apply to cruise ships operating outside of U.S. 
waters if the cruise ship operator intends for the ship to return to 
operating in international, interstate, or intrastate waterways that 
are subject to the jurisdiction of the United States during the period 
that this Order is in effect. The Order shall additionally apply 
regardless of whether the cruise ship operator has voluntarily agreed 
to suspend operations.

[[Page 62734]]

Background on CDC Actions To Control the Spread of COVID-19 on Cruise 
Ships

    Under the No Sail Order, as modified and extended on April 15 and 
July 16, 2020, cruise ship operations were limited, and cruise ship 
operators required to submit plans to prevent, mitigate, and respond to 
the spread of COVID-19 as a condition of obtaining or retaining 
controlled free pratique to engage in cruise ship operations in any 
international, interstate, or intrastate waterways that are subject to 
the jurisdiction of the United States. Cruise ship operators were also 
required to submit No Sail Order (NSO) response plans that ensured a 
safe environment for crew to work and disembark, and that minimized the 
impact on U.S. government operations or the operations of any state or 
local government, or the U.S. healthcare system.
    As of April 29, 2020, seven \20\ cruise ship operators submitted 
NSO response plans representing 108 cruise ships or about 95% of cruise 
ships subject to the April 15, 2020, modification and extension. As of 
September 6, all five \21\ cruise ship operators with ships remaining 
in U.S. waters have NSO response plans that are complete, accurate, and 
acknowledged. Only 31 out of the 108 ships (29%) that were in U.S. 
waters at the start of the NSO modification and extension on April 15 
remain in U.S. waters as of September 28, 2020. Pending approval of a 
cruise ship operator's NSO response plan, CDC allowed cruise ship 
operators to disembark and repatriate crew members from cruise ships in 
U.S. waters if the operator attested to complying with requirements to 
disembark crew members through noncommercial means so as to minimize 
the risk to other travelers and communities. Through this non-
commercial travel attestation process, CDC worked with cruise ship 
operators to assist in the disembarkation and safe return home of 
approximately 8,990 crew members, including 329 U.S. citizens and 
residents.
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    \20\ These operators included Bahamas Paradise Cruise Lines, 
Carnival Corporation, Disney Cruise Lines, Norwegian Cruise Line 
Holdings, Royal Caribbean Group, Virgin Voyages, and Windstar 
Cruises. MSC Cruises submitted an NSO response plan on May 7, 2020, 
covering three of its ships.
    \21\ Carnival Corporation, Virgin Voyages, and Windstar Cruises 
initially submitted NSO response plans but later withdrew their 
ships from U.S. waters. Accordingly, CDC has held its review of 
these NSO response plans in abeyance.
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    CDC published its Interim Guidance for Mitigation of COVID-19 Among 
Cruise Ship Crew During the Period of the No Sail Order to assist 
cruise ship operators in preventing, detecting, and medically managing 
confirmed and suspected cases of COVID-19 and exposures among crew 
members.\22\ CDC also established an enhanced surveillance process to 
provide a more complete picture of COVID-19 activity on cruise ships. 
Under the Interim Guidance, CDC requires weekly submission of the 
``Enhanced Data Collection (EDC) During COVID-19 Pandemic Form.'' \23\
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    \22\ CDC, Interim Guidance for Mitigation of COVID-19 Among 
Cruise Ship Crew During the Period of the No Sail Order at: https://www.cdc.gov/quarantine/cruise/management/interim-guidance-no-sail-order.html.
    \23\ This EDC Form is used to conduct surveillance for COVID-19 
among crew who remain on board cruise ships using cumulative reports 
of acute respiratory illness (ARI), influenza-like illness (ILI), 
and pneumonia, and other clinical indicators.
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    COVID-19 often presents as mild illness and many cases are 
asymptomatic among people of all ages. When symptoms are present, they 
are nonspecific and similar to those of many other respiratory 
infections and noninfectious conditions such as seasonal allergies. CDC 
Interim Guidance recommended that cruise ships' surveillance include 
routine viral testing for COVID-19, including intermittent testing of a 
random sample of symptomatic and asymptomatic crew members. Viral tests 
diagnose acute infection; the U.S. Food and Drug Administration-
authorized viral tests include those that detect SARS-CoV-2 nucleic 
acid (i.e., polymerase chain reaction [PCR]) or antigen (a rapid test).
    However, availability of such routine viral testing on cruise ships 
remains limited. For these reasons, CDC does not limit its data 
collection to just confirmed cases of COVID-19 but collects data on 
both confirmed cases and COVID-like illness. These data create a more 
accurate picture of the spread of COVID-19 and its effects in the 
United States and provide additional data to inform the national public 
health response. As of September 28, EDC reports have shown a total of 
6,088 PCR tests performed, 294 (5%) of which were positive for COVID-
19; 24 hospitalizations; two instances of mechanical ventilation; and 
15 medical evacuations for crew on ships within U.S. jurisdiction since 
April 13, 2020.
    CDC established a ``COVID-19 Color Coding System'' for ships 
applicable to cruise ship operators with an appropriate NSO 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 NSO response plans upon completion 
of CDC review of the plan. CDC additionally provides a provisional 
color status for ships belonging to cruise ship operators that do not 
yet have a complete and accurate 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.
    Since July 16, 2020, CDC has conducted implementation checks on 11 
cruise ships operating in U.S. jurisdiction to review compliance with 
the NSO. These implementation checks showed that cruise ship operators 
were adhering to the requirements of the NSO and their NSO response 
plans.

Challenges and Limitations in Testing Crew on Cruise Ships During the 
NSO

    While cruise ship operators have adhered to their NSO response 
plans during this time of suspended passenger operations, challenges 
remain. These challenges include the limitations of viral test results, 
including the possibility of false negative test results, the 
importance of crew quarantine in preventing disease spread, and 
concerns relating to reporting of symptoms by crew.
    Two specific cases help illustrate these challenges. In the first 
case, following a cruise ship operator's policy to test all newly 
embarking crew prior joining a ship, a crew member was tested in his 
home country and found to be PCR-negative for COVID-19 prior to flying 
to the United States to board the ship. Pursuant to CDC 
recommendations, the crew member immediately began a 14-day quarantine 
in a private cabin, and other crew members sanitized his boarding 
pathway after embarkation. Approximately 9 hours later during a routine 
temperature check, the crew member was found dead in bed.\24\ The 
cruise line contacted the decedent's family who reported that the crew 
member had a dry cough and itchy throat prior to traveling despite 
reporting no symptoms during the pre-boarding process. A postmortem 
nasopharyngeal swab was collected for PCR testing, and the result was 
positive for COVID-19.
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    \24\ This case is included in CDC's count of deaths from COVID-
19 based on the positive PCR test result and lack of any other 
apparent explanation for the cause of death.

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[[Page 62735]]

    In the second case, another crew member onboard the same ship was 
tested in his home country and was also PCR-negative for COVID-19 prior 
to flying to the United States to board the ship. Again, pursuant to 
CDC recommendations, the crew member immediately began a 14-day 
quarantine in a private cabin, and other crew members sanitized his 
boarding pathway after embarkation. During this quarantine period, the 
crew member developed symptoms of nasal congestion and upon examination 
was found to have a rapid heart rate without a fever. When the cruise 
ship performed PCR testing of all 174 crew, this crew member was the 
only one who tested positive for COVID-19, indicating that the crew 
member became infected in the crew member's home country before travel.
    These cases illustrate the importance of the 14-day quarantine 
period for embarking crew and how test results cannot eliminate the 
need for or reduce the length of quarantine. Testing represents a 
snapshot in time. A negative test result means that the virus that 
causes COVID-19 was not found in the sample collected. However, it is 
possible for any test to give a negative result that is incorrect 
(``false negative'') in some people with COVID-19; testing may also be 
negative while a person is in the 2-14-day incubation period for COVID-
19. The accuracy of any diagnostic test depends on many factors, 
including whether the sample was collected properly, whether the sample 
was maintained in appropriate conditions while it was shipped to the 
laboratory, and when during the course of the infection the testing was 
conducted.
    When viral testing is negative, the possibility of a false negative 
result should be considered in the context of the individual's recent 
exposures and the presence of clinical signs and symptoms consistent 
with COVID-19. The possibility of a false negative result should be 
considered especially if recent exposures or clinical presentation 
indicate that COVID-19 is likely, and diagnostic tests for other causes 
of illness (e.g., other respiratory illness) are negative. If COVID-19 
is still suspected based on exposure history together with other 
clinical findings, re-testing should be considered by healthcare 
providers in consultation with public health authorities.
    As these cases illustrate, a single negative test result cannot be 
used to rule out the possibility of COVID-19, especially if the 
individual may have been recently exposed to the virus or is displaying 
symptoms. Relying on crew testing alone without quarantine would not 
have been enough to prevent these two infected crew members from 
exposing others onboard. Despite preboarding screening efforts, one of 
these crew members was also reluctant to report symptoms. These factors 
should be considered carefully by cruise ship operators in planning for 
an eventual return to passenger operations.

Dangers of Prematurely Resuming Passenger Operations on Cruise Ships

    There have been several recent instances of outbreaks of COVID-19 
onboard cruise ships in those countries that have allowed passenger 
operations to resume, despite cruise ship operators implementing 
measures to control the disease. On the Hurtigruten cruise ship MS 
Roald Amundsen, 41 crew members and 21 passengers were confirmed to 
have COVID-19 after two voyages occurring between July 17-24 and July 
25-31 in Norway.\25\ The ship had 209 passengers on the first voyage 
and 178 on the second.\26\ The cruise ship operator permitted 
passengers to disembark on July 31, before the announcement of the 
outbreak, potentially spreading the virus to dozens of towns and 
villages along Norway's western coast and setting off an effort by 
public health authorities to trace and locate the nearly 400 
potentially exposed passengers.\27\ While the outbreak onboard the MS 
Roald Amundsen is still under investigation, Hurtigruten has revealed 
that its internal review ``uncovered several deviations from 
procedures, for example when it comes to quarantining foreign crews and 
the internal flow of important information.'' \28\
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    \25\ Hurtigruten crew members and guests test positive for 
COVID-19, https://www.hurtigruten.com/practical-information/coronavirus-update/ra31072020/. Last accessed September 30, 2020.
    \26\ AP News, Outbreak hits Norway cruise ship, could spread 
along coast, https://apnews.com/781a3fa3faabde06d44749bfe57139da. 
Last accessed September 30, 2020.
    \27\ Maritime Executive, Hurtigruten's COVID-19 Fallout 
Continues, https://www.maritime-executive.com/index.php/article/fallout-continues-from-hurtigruten-s-covid-19-incident. Last 
accessed September 30, 2020.
    \28\ The COVID-19 situation: Update from Hurtigruten, https://presse.hurtigruten.no/pressreleases/the-covid-19-situation-update-from-hurtigruten-3024635. Last accessed September 30, 2020.
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    Cases of COVID-19 have also been documented on other cruise ships 
that have attempted to resume passenger operations. The SeaDream Yacht 
Club temporarily halted cruising onboard the SeaDream I in July after a 
passenger who had previously shown no symptoms disembarked from the 
ship and tested positive for COVID-19 upon returning to his home 
country of Denmark.\29\ The Tahiti-based Paul Gauguin cruises had a 
passenger test positive for COVID-19 just three days into its first 
voyage with international passengers.\30\ The incident required the 
French Polynesia High Commission to initiate a contact-tracing 
investigation to determine who may have been exposed to the passenger 
in question.\31\ About 148 passengers and 192 crew members were on 
board the cruise ship at the time.\32\ In late July, ten crew members 
on board AIDA Cruises' AIDAblu and AIDAmar tested positive for COVID-19 
after boarding in Rostok, Germany.\33\ In the United States, Uncruise 
Adventures canceled its remaining voyages in Alaska after a passenger 
on board the 60-person \34\ passenger vessel Wilderness Adventurer 
tested positive for COVID-19.\35\ The incident necessitated a contact 
tracing investigation by Alaska public health authorities and the 
quarantine of passengers at a hotel in Juneau and of crew on board the 
ship.\36\
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    \29\ Travel Weekly, Another small-ship line reports a passenger 
with a positive Covid test, https://www.travelweekly.com/Cruise-Travel/SeaDream-reports-passenger-with-a-positive-Covid-test. Last 
accessed September 30, 2020.
    \30\ The Maritime Executive, One Suspected COVID-19 Case On 
Cruise Ship Paul Gauguin, https://www.maritime-executive.com/article/one-suspected-covid-19-case-on-cruise-ship-paul-gauguin. 
Last accessed September 30, 2020.
    \31\ Id.
    \32\ Id.
    \33\ USA Today, Ten AIDA cruise crew members test positive for 
COVID-19; ships will still sail in August, https://www.usatoday.com/story/travel/cruises/2020/07/28/aida-cruises-crew-members-test-positive-covid-19/5525310002/. Last accessed September 30, 2020.
    \34\ This is below the capacity established by the NSO for 
passenger-carrying vessels.
    \35\ Uncruise Adventures, Press Release, https://www.uncruise.com/about-us/media/press-releases/covid-cruise-not-uncruise-adventures. Last accessed September 30, 2020.
    \36\ Id.
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    In the above examples, cruise ship operators had health and safety 
protocols to prevent the transmission and spread of COVID-19. The 
protocols adopted by the Hurtigruten included new sanitation measures, 
elimination of self-serve buffet dining, implementation of onboard 
social distancing procedures, operating at 50% capacity, a preboarding 
health questionnaire, and restricted shore excursions.\37\ While 
investigations are still ongoing, the statement by Hurtigruten's CEO 
that the company failed to abide by its own

[[Page 62736]]

protocols \38\ suggests a need for further education, training, and 
experience in implementing new health and safety protocols prior to 
resuming passenger operations in any significant capacity.
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    \37\ https://www.hurtigruten.com/practical-information/health-and-safety-on-board/. Last accessed September 30, 2020.
    \38\ Seatrade Cruise News, 'Mistakes were made . . . We failed' 
to follow own coronavirus protocols: Hurtigruten CEO, https://www.seatrade-cruise.com/news/mistakes-were-made-we-failed-follow-own-coronavirus-protocols-hurtigruten-ceo. Last accessed September 
30, 2020.
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    In these examples, even when health and safety protocols were 
apparently observed, resuming passenger operations significantly 
burdened public health authorities by creating the need for additional 
testing, contact tracing, and quarantine. While the SeaDream Yacht Club 
has claimed that the passenger on board the SeaDream I was a ``false 
positive,'' a statistically rare event,\39\ the incident still 
necessitated the quarantine of passengers and non-essential crew as 
directed by the Norwegian Directorate of Health as a public health 
precaution.\40\ Paul Gauguin cruises required passengers to present 
proof of a negative COVID-19 test (PCR) at embarkation, excluding 
residents and visitors who had been in French Polynesia for more than 
14 days,\41\ yet the French Polynesia High Commission still conducted a 
lengthy contact investigation after a passenger later tested positive. 
The ship was carrying approximately 148 passengers (less than half of 
its 332-guest capacity) and 192 crew members at the time of the 
outbreak.\42\ In the case of the AIDA cruise ships, all ten crew 
members initially tested negative in their home countries of Indonesia 
and the Philippines, yet when retested upon arrival in Germany were 
determined to be positive and required isolation on board the cruise 
ships.\43\ A quarantine under the supervision of the local public 
health authority was similarly required when a passenger who had tested 
negative upon boarding the Uncruise Adventures' Wilderness Adventurer 
subsequently tested positive. In these examples, voyages were 
cancelled, passengers and crew quarantined or isolated, and contact 
tracing investigations conducted for those on the ship and for 
passengers who had returned to their home communities.
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    \39\ Watson J, Whiting PF, Brush JE. Interpreting a covid-19 
test result. BMJ 2020; 369: m1808. doi: https://www.bmj.com/content/369/bmj.m1808. Last accessed September 30, 2020.
    \40\ The Maritime Executive, Third Cruise Ship in a Week Reports 
COVID-19 Situation in Norway, https://www.maritime-executive.com/article/third-cruise-ship-in-a-week-reports-covid-19-situation-in-norway. Last accessed September 30, 2020.
    \41\ https://www.pgcruises.com/travel-advisory. Last accessed 
September 30, 2020.
    \42\ Paul Gauguin Ship Returns to Port After Suspected COVID-19 
Case, https://www.msn.com/en-us/travel/news/paul-gauguin-ship-returns-to-port-after-suspected-covid-19-case/ar-BB17wniX. Last 
accessed September 30, 2020.
    \43\ Crew Center, 10 Crew Members of AIDA Cruises Test Positive 
for COVID-19, https://crew-center.com/10-crew-members-aida-cruises-test-positive-covid-19. Last accessed September 30, 2020.
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More Time Needed To Assess Effectiveness of Proposed Public Health 
Interventions Prior to Resuming Passenger Operations

    Cruise ship operators have taken steps to advance their public 
health response to COVID-19, improve safety, and achieve readiness to 
safely resume passenger operations. Under the co-chairmanship of former 
Health and Human Services Secretary Michael O. Leavitt, 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.\44\ 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.'' \45\ MSC 
Cruises further established its own industry-led panel with 
``competency to review policy initiatives, technical innovations, or 
operational measures related to COVID-19,'' \46\ and will presumably 
implement these recommendations as its passenger operations continue to 
resume in the Mediterranean with residents of Schengen countries.\47\ 
At the moment, however, it is too early to assess whether these 
initiatives will produce a viable set of policies and practices that 
will mitigate the transmission and spread of COVID-19 onboard cruise 
ships while minimizing the potential burden and need for public health 
response activities.
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    \44\ https://www.rclcorporate.com/royal-caribbean-group-and-norwegian-cruise-line-holdings-form-healthy-sail-panel/. Last 
accessed September 30, 2020.
    \45\ Press Release, https://www.carnivalcorp.com/news-releases/news-release-details/world-leading-experts-headline-covid-19-summit-hosted-wttc. Last accessed September 30, 2020.
    \46\ MSC Cruise Announces Blue-Ribbon COVID Expert Group, 
Engages Specialized Maritime Classification Society to Provide 
Third-Party Verification That Its Protocol Meets Established 
Guidance, https://www.msccruisesusa.com/news/blue-ribbon-covid-expert-group. Last accessed September 30, 2020.
    \47\ Cruise Critic News, MSC Cruises Restarts Cruising in the 
Mediterranean, https://www.cruisecritic.com/news/5533/. Last 
accessed September 30, 2020.
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    To gather more information regarding these industry-led efforts 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.\48\ The document had a comment period 
that ended on September 21, 2020 and almost 13,000 comments were 
received. In light of the number of submissions and high level of 
public interest, additional time is needed for CDC to review these 
comments, which may be used to inform future public health guidance and 
preventive measures relating to travel on cruise ships.
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    \48\ Request for Information Related to Cruise Ship Planning and 
Infrastructure, Resumption of Passenger Operations, and Summary 
Questions, https://www.federalregister.gov/documents/2020/07/21/2020-15812/request-for-information-related-to-cruise-ship-planning-and-infrastructure-resumption-of-passenger. Last accessed September 
30, 2020.
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Findings and Immediate Action

    The continued spread of the COVID-19 pandemic worldwide, risk of 
resurgence in countries that have suppressed transmission, ongoing 
concerns related to the restart of cruising internationally, and need 
for additional time to assess industry measures to control potential 
COVID-19 onboard cruise ships with passengers without burdening public 
health, support continuing to defer resumption of passenger operations 
at this time.
    Accordingly, and consistent with 42 CFR 70.2, 71.31(b), and 
71.32(b), the Director of CDC (``Director'') continues to find that 
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, 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.
    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.\49\ This

[[Page 62737]]

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 and July 16, 2020, modifications 
and extensions. As a result, 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.\50\ Additionally, persons infected on cruise ships would be 
likely to transmit COVID-19 to U.S. communities by traveling interstate 
after cruising.
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    \49\ 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.
    \50\ 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 33 million as of September 28, 2020, 
with more than 1 million deaths. See Situation Reports, WHO, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports.
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    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.
    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). 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 there is good 
cause to dispense with prior public notice and the opportunity to 
comment on this Order.\51\ 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.
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    \51\ See 5 U.S.C. 553(b)(B), (d)(3).
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    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:
Measures Related To Protecting Public Health of Communities Signed on 
March 14, 2020
    These measures were implemented to provide public health 
authorities, in concert with the cruise ship industry, the necessary 
pause in operations to develop and implement an appropriate and robust 
plan (1) to prevent and mitigate the further spread of COVID-19 in 
communities, and (2) to prevent the spread of the disease onboard and 
ensure the health of cruise ship passenger and crew.
    Accordingly, the following terms and conditions of the No Sail 
Order and Other Measures Related to Operations signed on March 14, 
2020, as modified and extended by this order, shall remain in effect. 
Consequently, it remains ordered:
    1. Cruise ship operators shall not disembark or reembark crew 
members except as directed by the USCG, in consultation with HHS/CDC 
personnel and, as appropriate, as coordinated with Federal, State, and 
local authorities.
    2. Cruise ship operators shall not embark any new passengers or 
crew, except as approved by USCG, or other Federal authorities as 
appropriate, in consultation with HHS/CDC personnel.
    3. While in port, the cruise ship operator shall observe health 
precautions as directed by HHS/CDC personnel.
    4. The cruise ship operator shall comply with all HHS/CDC, USCG, 
and other Federal agency instructions to follow CDC recommendations and 
guidance for any public health actions relating to passengers, crew, 
ship, or any article or thing on board the ship, as needed, including 
by making ships' manifests and logs available and collecting any 
specimens for COVID-19 testing.
Measures Related to Protecting Public Health and Crew Safety Signed on 
April 9, 2020, and Made Effective on April 15, 2020
    These measures were implemented to, among other things, ensure a 
safe environment for crew members to work and disembark by requiring 
the submission of appropriate NSO response plans by cruise ship 
operators as a condition of obtaining controlled free pratique \52\ to 
continue to engage in any cruise ship operations in any international, 
interstate, or intrastate waterways that are subject to the 
jurisdiction of the United States.
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    \52\ 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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    Accordingly, the terms and conditions of the Modification and 
Extension of No Sail Order and Other Measures Related to Operations, 
intended to protect public health and crew safety, signed on April 9, 
2020, and made effective on April 15, 2020, as modified and extended by 
this order, shall remain in effect. Consequently, it remains ordered:
    1. As a condition of obtaining controlled free pratique to continue 
to engage in any cruise ship operations in any international, 
interstate, or intrastate waterways that are subject to the 
jurisdiction of the United States, cruise ship operators shall develop, 
implement, and operationalize, an appropriate, actionable, and robust 
plan to prevent, mitigate, and respond to the spread of COVID-19 among 
crew onboard cruise ships.
    2. As a condition of obtaining controlled free pratique to continue 
to engage in any cruise ship operations in any international, 
interstate, or intrastate waterways that are subject to the 
jurisdiction of the United States, the cruise ship operator shall make 
the plan described in paragraph 1, above, available to HHS/CDC and USCG 
personnel.
    3. An appropriate plan is one that adequately prevents, mitigates, 
and responds to the spread of COVID-19 among crew onboard cruise ships 
and that, at a minimum, addresses the following elements:
    a. Onboard surveillance of crew with acute respiratory illnesses, 
influenza-like illnesses, pneumonia, and COVID-19, including reporting 
to HHS/CDC on a weekly basis on overall case counts, methods of 
testing, and number of crew requiring hospitalization or medical 
evacuation;

[[Page 62738]]

    b. Reports on the number of crew onboard the cruise ship and any 
increase in the numbers of crew with COVID-19 made to HHS/CDC and USCG 
on a daily basis for as long as the cruise ship is within waters 
subject to the jurisdiction of the United States.
    c. Onboard monitoring of crew through temperature checks and 
medical screening, including addressing frequency of monitoring and 
screening;
    d. Training of all crew on COVID-19 prevention, mitigation, and 
response activities;
    e. Protocols for any COVID-19 testing, including details relating 
to the shore-side transport, administration, and operationalization of 
laboratory work if onboard laboratory work is not feasible;
    f. Onboard isolation, quarantine, and social distancing protocols 
to minimize the risk of transmission and spread of COVID-19;
    g. Onboard medical staffing, including number and type of staff, 
and equipment in sufficient quantity to provide a hospital level of 
care (e.g., ventilators, facemasks, personal protective equipment) for 
the infected so as to minimize the need for hospitalization onshore;
    h. An outbreak management and response plan to provision and assist 
an affected cruise ship that relies on industry resources, e.g., 
mobilization of additional cruise ships or other vessels to act as 
``hospital'' ship for the infected, ``quarantine'' ship for the 
exposed, and ``residential'' ship for those providing care and 
treatment, including the ability to transport individuals between ships 
as needed;
    i. Categorization of affected crew into risk categories with clear 
stepwise approaches for care and management of each category;
    j. A medical care plan addressing onboard care versus evacuation to 
on-shore hospitals for critically ill crew, specifying how availability 
of beds for critically ill at local hospitals will be determined in 
advance and how the cruise ship operator will ensure acceptance at 
local medical facilities to treat the critically ill in a manner that 
limits the burden on Federal, State, and local resources and avoids, to 
the greatest extent possible, medivac situations. If medical evacuation 
is necessary arrangements for evacuation must be made with commercial 
resources (e.g., ship tender, chartered standby vessel, chartered 
airlift) and arrangements made with a designated medical facility that 
has agreed to accept such evacuees. All medical evacuation plans must 
be coordinated with the U.S. Coast Guard;
    k. Detailed logistical planning for evacuating and repatriating 
both U.S. citizens and foreign nationals to their respective 
communities and home countries via foreign government or industry-
chartered private transport and flights, including the steps the cruise 
ship operator will take to ensure those involved in the transport are 
not exposed (i.e., without the use of commercial flights to evacuate or 
repatriate individuals, whether within or from the United States);
    l. The projected logistical and resource impact on State and local 
government and public health authorities and steps taken to minimize 
the impact and engage with these authorities; all plans must provide 
for industry/cruise line management of suspected or confirmed cases of 
COVID-19 without resource burden on Federal, State, or local 
governments;
    m. Plan execution in all U.S. geographical areas--all plans must be 
capable of being executed anywhere in international, interstate, or 
intrastate waterways that are subject to the jurisdiction of the United 
States; and
    n. Cleaning and disinfection protocols for affected cruise ships.
    4. An appropriate plan shall be designed 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.
    5. The cruise ship operator shall further ensure that the plan is 
consistent with the most current CDC recommendations and guidance for 
any public health actions related to COVID-19. Where appropriate, a 
cruise ship operator may coordinate the development, implementation, 
and operationalization of a plan with other cruise ship operators, 
including an industry trade group.
Measures Related to Continued Protection of Public Health and Crew 
Safety Signed on July 16, 2020, as Modified and Extended by This Order
    These measures were intended to continue to protect U.S. 
communities, ensure a safe environment for crew to work and disembark, 
and defer the embarkation of passengers until there is a clear pathway 
for a safe return to passenger operations.
    Accordingly, the terms and conditions of the Second Modification 
and Extension of No Sail Order and Other Measures Related to 
Operations, signed on July 16, 2020, as modified and extended by this 
order, shall remain in effect.
    Consequently, it remains ordered:
    1. Cruise ship operators shall continue to suspend passenger 
operations and not embark passengers, except as approved by HHS/CDC 
personnel and USCG, in consultation with other federal authorities as 
appropriate.
    2. As a condition of obtaining or retaining controlled free 
pratique to operate in any international, interstate, or intrastate 
waterways that are subject to the jurisdiction of the United States, 
cruise ship operators shall continue to follow CDC's Interim Guidance 
for Mitigation of COVID-19 Among Cruise Ship Crew During the Period of 
the No Sail Order, including reporting to HHS/CDC through weekly 
submission of the Enhanced Data Collection (EDC) form, as may be 
updated. Additionally, cruise ship operators shall report to USCG via 
Advance Notice of Vessel Arrival (ANOA), whenever in U.S. waters.
    3. 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 following conditions must be met prior to a ship 
returning to U.S. waters: (1) submission of the EDC form for 28-days 
preceding expected arrival in U.S. waters; and (2) having a complete 
and accurate NSO response plan, including having submitted to CDC a 
signed Acknowledgment of No Sail Order Response Plan Completeness and 
Accuracy.
    4. As a condition of obtaining or retaining controlled free 
pratique to operate in any international, interstate, or intrastate 
waterways that are subject to the jurisdiction of the United States, 
cruise ship operators with appropriate NSO response plans shall 
continue to follow the COVID-19 Color Coding System for Cruise Ships 
During the Period of the No Sail Order requiring preventive measures 
for crew onboard based on the ship's status, as determined by HHS/CDC.
    5. As a condition of obtaining or retaining controlled free 
pratique to operate in any international, interstate, or intrastate 
waterways that are subject to the jurisdiction of the United States, 
cruise ship operators with appropriate NSO response plans shall conduct 
viral testing for COVID-19 for crew in such a manner as described in 
the relevant CDC guidance with reporting of results on the EDC form.
    6. As a condition of obtaining or retaining controlled free 
pratique to operate in any international, interstate, or intrastate 
waterways that are subject to the jurisdiction of the United States, 
cruise ship operators must observe the requirements of this Order, the 
previous Orders, and the most current CDC

[[Page 62739]]

recommendations and guidance for any public health actions related to 
COVID-19, even when outside of U.S. waters for any ships that intend to 
return to U.S. waters during the period that this Order remains in 
effect.
    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) October 31, 
2020.

    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 1, 2020.
Nina B. Witkofsky,
Acting Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2020-22030 Filed 10-1-20; 11:15 am]
BILLING CODE 4163-18-P