Framework for Conditional Sail FRN

Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–24474 Filed 11–3–20; 8:45 am]
BILLING CODE 4163–18–P

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

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.

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SUMMARY:

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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/index.html.

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.

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

Previous Orders and Incorporation by
Reference

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

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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.
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;
1 No Sail Order and Suspension of Further
Embarkation. https://www.federalregister.gov/
documents/2020/03/24/2020-06166/no-sail-orderand-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-offurther-embarkation-notice-of-modification-andextension-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-orderand-suspension-of-further-embarkation-secondmodification-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-orderand-suspension-of-further-embarkation-thirdmodification-and-extension-of-no-sail. Last
accessed October 19, 2020.

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• 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 °F [38 °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
5 Cruise ships are defined in the same manner as
in CDC’s No Sail Orders, as extended and modified,

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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
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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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.

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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
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).
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
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.
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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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.
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
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.
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

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(ARI),10 influenza-like illness (ILI),11
pneumonia, and other clinical
indicators of COVID–19 (85 FR 62732).
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 shipspecific 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/crewdisembarkations-commercialtravel.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).
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 °F [38 °C]) plus either cough or sore throat.

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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
Rocklo¨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.
Rocklo¨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
12 Rocklo
¨ v J, Sjo¨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: http://
dx.doi.org/10.15585/mmwr.mm6923e4.

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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

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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

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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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

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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

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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.
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
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.

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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.
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:

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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
16 See

5 U.S.C. 553(b)(B), (d)(3).

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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. Thirdparty 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

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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

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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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.

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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:

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(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 preexisting 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

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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 checkin,
(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

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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
(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.

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 ‘‘afteraction’’ 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
(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.

(a) A cruise ship operator must submit
the following to CDC prior to
commencing restricted passenger
operations: 18
(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

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.

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.

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Applying for a COVID–19 Conditional
Sailing Certificate

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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

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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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.

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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.

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(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

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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–19Affected 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.

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(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.

khammond on DSKJM1Z7X2PROD with NOTICES

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, thirdparty 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.

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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).
(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
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.

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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 SARSCoV–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

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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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.

khammond on DSKJM1Z7X2PROD with NOTICES

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.

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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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–20PA]

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘DOP CrossSite Program Implementation
Evaluation of Overdose Data to Action
Program’’ to the Office of Management
and Budget (OMB)for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on 06/15/
2020 to obtain comments from the
public and affected agencies. CDC did
not receive public comments related to
the previous notice. This notice serves
to allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencie’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;

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(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
DOP Cross-Site Program
Implementation Evaluation of Overdose
Data to Action Program—New—
National Center for Injury Prevention
and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Overdose Data to Action (OD2A)
program is a comprehensive, national
overdose prevention program developed
by CDC. The purpose of the OD2A
program is to support funded
jurisdictions in obtaining high quality,
complete, and timely data on opioid
prescribing and overdoses, and to use
those data to inform prevention and
response efforts. OD2A funds a total of
66 recipients (state and local health
departments) to implement surveillance
and prevention strategies, through a
three-year cooperative agreement.
This information collection review is
focused on the tools needed to evaluate
the unique OD2A program. This
information collection includes key
informant interviews (KII) and focus
groups (FG). The information collection
is unique and will be the first evaluation
of the OD2A program. There are no
other efforts that CDC knows of to
obtain program information required to

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