Attachment D_Temporary Extension and Modification of Framework for Conditional Sailing Order

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PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)—Continued
KQ1: pre-treatment
nutritional interventions
(PNIs)

PICOTS

KQ2: nutritional interventions during treatment (NIDTs)

KQ3: pre- or during treatment nutritional interventions (NIs) and patient-centered outcomes

KQ4: weight loss in overweight/obese adults
with cancer

Timing ..................

Nutritional interventions delivered pre- cancer treatment (KQ1, KQ3, KQ4) and during cancer treatment (KQ2, KQ3, KQ4).

Setting .................

Outpatient Oncology Care, Ambulatory Care, Cancer Treatment Centers, inpatient, home-based, hospice, telemedicine.

Abbreviations: KQ = key question; BMI = body mass index; ER = emergency room; PICOTS = population, intervention, comparator, outcomes, timing, setting; RCT
= randomized controlled trial; NRCT = non-randomized controlled trial.

Dated: October 22, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–23456 Filed 10–27–21; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Temporary Extension and Modification
of Framework for Conditional Sailing
Order (CSO) for Cruise Ships
Operating or Intending To Operate in
U.S. Waters
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 temporary extension and modification
of the Framework for Conditional
Sailing Order (CSO).
DATES: This action is effective
November 1, 2021, at 12:01 a.m. EDT
upon the expiration of the current
Order.
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: dgmqpolicyoffice@cdc.gov.
SUPPLEMENTARY INFORMATION: This
Order temporarily extends and modifies
the Framework for Conditional Sailing
Order (CSO). This Order only applies to
cruise ship operators in U.S.
jurisdictions where foreign-flagged
ships port or travel on international
itineraries and state and local health
departments do not routinely exercise
public health jurisdiction nor maintain
maritime public health programs that
conduct surveillance, inspections,
investigations, and management for
communicable diseases with potential
for significant morbidity and mortality
onboard foreign-flagged ships. These

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SUMMARY:

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specific jurisdictions are listed below in
the Order.
This Order additionally applies to
foreign-flagged 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.
As per the Preliminary Injunction
Order, entered by the U.S. District Court
for the Middle District of Florida on
June 18, 2021, as of July 23, 2021, the
CSO and accompanying measures, such
as technical instructions, are
nonbinding recommendations for cruise
ships arriving in, located within, or
departing from a port in Florida.
Accordingly, this Order shall not apply
to this subset of ships while this
Preliminary Injunction Order remains in
effect (or in the event the Preliminary
Injunction becomes permanent).
However, CDC will continue to operate
the CSO as a voluntary program for such
ships should they choose to follow the
CSO measures on a voluntary basis.
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)
Temporary Extension & Modification of
Framework for Conditional Sailing
Order (CSO)
Executive Summary
The Centers for Disease Control and
Prevention is temporarily extending the
Framework for Conditional Sailing
Order (CSO) issued on October 30, 2020.
Since the issuance of the CSO, cruise
lines, with CDC assistance, have
resumed passenger operations and
successfully developed and
implemented health and safety
protocols to manage COVID–19 that

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have averted overwhelming onboard
medical facilities and burdening
shoreside hospital resources. However,
considering the continued spread of the
Delta variant, emergence of other
COVID–19 variants of concern,
breakthrough cases among the fully
vaccinated, and possible additional
surges of cases and deaths, CDC has
determined a temporary extension of the
CSO is necessary for foreign-flagged
cruise ships operating on international
itineraries. After the expiration of this
temporary extension, CDC intends to
transition to a voluntary program, in
coordination with interested cruise ship
operators and other stakeholders, to
assist the cruise ship industry to detect,
mitigate, and control the spread of
COVID–19 onboard cruise ships.
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) January 15, 2022 at 12:01 a.m. (EST).
Previous Orders and Incorporation by
Reference
The findings and other evidence
relied upon in issuing the CSO are
incorporated herein by reference. Any
ambiguity between the October 30, 2020
Order, as further modified and extended
by the current Order, shall be resolved
in favor of the current Order.
Applicability
This temporary renewal and
modification of the CSO shall apply
only to the subset of carriers 1 described
below and hereinafter referred to as
‘‘cruise ships’’:
All commercial, non-cargo,2 foreignflagged,3 passenger-carrying vessels operating
1 Carrier is defined by 42 CFR 71.1 to mean, ‘‘a
ship, aircraft, train, road vehicle, or other means of
transport, including military.’’
2 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.
3 This Order modifies the CSO so that it is
applicable only to foreign-flagged vessels that per
46 U.S.C. 55103 may not travel between U.S. ports

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in U.S. waters with the capacity 4 to carry
250 5 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.6

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This Order shall additionally apply to
foreign-flagged 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.
As explained further in this Order,
based on the CDC Director’s
determination of inadequate local
control under 42 CFR 70.2,7 this Order
shall only apply to cruise ship operators
in U.S. jurisdictions where foreignflagged ships port or travel on
international itineraries and state and
local health departments do not
routinely exercise public health
jurisdiction nor maintain maritime
public health programs that conduct
surveillance, inspections, investigations,
and management for communicable
diseases with potential for significant
without including a stop at a foreign port in their
itinerary. Because foreign-flagged vessels typically
operate on international itineraries far from U.S.
shores, outbreaks on such vessels are more likely
to require emergency medical evacuations while at
sea and thus burden U.S. Coast Guard and other
emergency medical response resources.
Furthermore, stopping in a foreign port increases
the risk of introducing a COVID–19 variant of
concern into the United States. [International Travel
During COVID–19 ⎢ CDC].
4 A ship’s capacity shall be determined based on
the number of persons listed in the U.S. Coast
Guard Certificate of Compliance issued in
accordance with 46 CFR 2.01–6 and that was in
effect on October 30, 2020.
5 CDC continues to define cruise ships as those
with a capacity to carry 250 or more passengers and
crew 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.
6 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.
7 Because this Order applies only to foreignflagged vessels that per 46 U.S.C. 55103 may not
travel between U.S. ports without including a stop
at a foreign port in their itinerary, 42 CFR 71.31(b),
71.32(b), constitute sufficient legal authority to
support this Order. However, 42 CFR 70.2 provides
additional legal authority and support to the extent
that it is needed for the reasons explained in this
Order.

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morbidity and mortality 8 onboard
foreign-flagged ships.9
As per the Preliminary Injunction
Order, entered by the U.S. District Court
for the Middle District of Florida on
June 18, 2021, as of July 23, 2021, the
CSO and accompanying measures, such
as technical instructions, are
nonbinding recommendations for cruise
ships arriving in, located within, or
departing from a port in Florida.
Accordingly, this Order shall not apply
to this subset of ships while this
Preliminary Injunction Order remains in
effect (or in the event the Preliminary
Injunction becomes permanent).
However, CDC will continue to operate
the CSO as a voluntary program for such
ships should they choose to follow the
CSO measures on a voluntary basis.
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.
Summary of CSO Extension Compared
to Previous CSO
This temporary extension of the CSO
leaves major provisions of the previous
CSO unchanged with only minor
modifications to incorporate changes in
technical instructions made based on
8 In addition to quarantinable communicable
diseases as defined under 42 CFR 70.1 and 71.1,
communicable diseases with potential for
significant morbidity and mortality include diseases
that spread from person to person, such as
respiratory diseases (e.g., varicella, mumps,
pertussis, meningococcal disease) and norovirus,
and those that arise from contaminated food,
potable water, or recreational water (e.g.,
Salmonella, Escherichia coli, Cryptosporidium), or
the environment, such as Legionnaires’ disease.
9 These jurisdictions include the following U.S.
states: Alabama, Alaska, California, Delaware,
Florida, Georgia, Hawaii, Illinois, Louisiana, Maine,
Maryland, Massachusetts, Michigan, Minnesota,
Mississippi, New Hampshire, New Jersey, New
York, North Carolina, Ohio, Oregon, Pennsylvania,
Rhode Island, South Carolina, Texas, Virginia, and
Washington State. These jurisdictions also include
the following U.S. territories: American Samoa,
Guam, Northern Mariana Islands, Puerto Rico, and
the U.S. Virgin Islands. CDC is not currently aware
of any states or U.S. territories operating a maritime
public health program that would displace the CSO.

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discussions and feedback from cruise
ship operators and announced through
‘‘Dear Colleague’’ communications to
industry partners. Accordingly, CDC
does not view this temporary extension
as imposing any new burdens or
obligations on cruise ship operators
when compared to the previous CSO. As
further explained in this extension, the
most significant change is to narrow the
applicability of the CSO to ‘‘foreignflagged’’ cruise ships operating in U.S.
jurisdictions that do not routinely
exercise public health jurisdiction nor
maintain maritime public health
programs that conduct surveillance,
inspections, investigations, and
management for communicable diseases
with potential for significant morbidity
and mortality onboard foreign-flagged
ships.
Currently, there is only one cruise
ship operator under the CSO that is not
foreign-flagged and operates its ships
exclusively in interstate waterways
subject to the jurisdiction of the United
States. Unlike ocean-going foreignflagged vessels, in the event of an
outbreak, interstate vessels typically
operate in such a manner that, should
an outbreak occur, passengers and crew
can be quickly brought by ambulance to
local hospitals without requiring airlifts
or evacuations at sea that significantly
burden U.S. Coast Guard or potentially
overwhelm public health resources.10
Interstate vessels also operate under the
jurisdiction of the Food and Drug
Administration’s (FDA) Interstate Travel
Program and are subject to additional
federal oversight under the provisions of
21 CFR 1240, 1250. Accordingly, CDC
believes that narrowing the application
of the CSO in this manner does not
jeopardize the public’s health.
Furthermore, should this cruise ship
operator choose to do so, it may
continue to follow the CSO on a
voluntary basis.
CDC provides the following chart to
further explain how key substantive
10 Another cruise ship operator has one U.S.flagged cruise ship that operates solely between
Hawaiian Islands. Similar to interstate vessels, the
ship can quickly make port and bring passengers
and crew by ambulance to local hospitals without
requiring airlifts or evacuations at sea that
significantly burden U.S. Coast Guard or potentially
overwhelm public health resources. While foreignflagged cruise ships operating on the Great Lakes
may, depending on their itineraries, be able to
return to port more quickly than ocean-going
vessels, based on their international itineraries they
would not fall under FDA’s Interstate Travel
Program. Furthermore, as discussed elsewhere, state
and local health departments are engaged in other
COVID–19 response efforts. Accordingly, excluding
foreign-flagged vessels operating international
itineraries on the Great Lakes from the application
of this Order would create a regulatory gap.

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provisions of this temporary extension
operate compared to the previous CSO:
CSO sections

Modifications

Acronyms, Initialisms, and Definitions ......................................................
Purpose and Scope ..................................................................................
General Prohibition on a Cruise Ship Operator Commencing or Continuing Passenger Operations without a COVID–19 Conditional Sailing Certificate.
Requirements for COVID–19 Response Plan for Cruise Ship Operators
Operating or Intending to Operate Cruise Ships in U.S. Waters.
Requirements for COVID–19 Testing Capabilities and Reporting for
Cruise Ship Operators Operating or Intending to Operate Cruise
Ships in U.S. Waters.
Agreement with Port and Local Health Authorities ..................................
Minimum Standards for Simulated Voyages Prior to Issuance of
COVID–19 Conditional Sailing Certificate.
Procedures in Lieu of Conducting a Simulated Voyage for Cruise Ship
Operators Transitioning to Voyages with Less Than 95% of Passengers Fully Vaccinated.
Modified Simulated Voyage Requirements in Lieu of a Full Simulated
Voyage for Cruise Ship Operators Repositioning to U.S. Waters and
Intending to Operate with Less than 95% of Passengers Fully Vaccinated.
Applying for a COVID–19 Conditional Sailing Certificate ........................

Review of an Application for a COVID–19 Conditional Sailing Certificate.
Amendment or Modification of COVID–19 Conditional Sailing Certificate
Unchanged from original CSO.
Minimum Standards for Restricted Passenger Voyages as a Condition
of Obtaining and Retaining a COVID–19 Conditional Sailing Certificate.
Minimum Standards for Management of Passengers and Crew from
COVID–19-affected Cruise Ships for Restricted Passenger Voyages.

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Denials, Suspension, Revocation, and Reinstatement of a Cruise Ship
Operator’s COVID–19 Conditional Sailing Certificate.
Administrative review ................................................................................

Acronyms, Initialisms, and Definitions
(a): The acronyms and initialisms
below will have the following meaning:
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–19-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.

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• Definition of cruise ships narrowed by adding ‘‘foreign-flagged’’.
• Unchanged.
• Unchanged.
• Previously referred to as ‘‘No Sail Order (NSO) Response Plans’’.
• No changes for operators with previously approved plans.
• No new requirements: cruise ship operators completed requirements
as part of previous CSO ‘‘Phase 1’’ crew testing.
• Modified to incorporate current Technical Instructions for Crew.
• Modified to incorporate current Port Agreement Technical Instructions.
• Removed language referring to cruise ship operator protocols as
‘‘unproven and untested’’.
• Modified to incorporate current Technical Instructions for Simulated
Voyages.
• New provision aimed at reducing potential industry burden for certain
operators.
• Based on ‘‘Dear Cruise Industry Colleagues’’ email sent on September 21, 2021. Webpage updates pending.
• New provision aimed at reducing potential industry burden for certain
operators.
• Based on ‘‘Dear Cruise Industry Colleagues’’ email sent on September 21, 2021. Webpage updates pending.
• Shortened CDC’s time to respond to an application from 60 days to
5 days based on ‘‘Dear Cruise Industry Colleagues’’ letter of April
28, 2021.
• Removed requirement for an attestation under 18 U.S.C. 1001 in line
with intent to operate future program on a voluntary basis.
• Removed requirement to submit a copy of the USCG Certificate of
Inspection.
• Removed requirement to submit proof of inspection by any other
agency.
• Unchanged.
• Removed requirement to include any CDC travel advisory, warning,
or recommendation relating to cruise travel in marketing material.
• Removed requirement to limit voyage to 7 days.
• Removed requirement for monitored observation period of passengers prior to embarking.
• Modified to state that voyage may be ended and further action taken
if a ship meets ‘‘red ship criteria’’ under Technical Instructions for
Crew.
• Removed previous requirement that cruise ship operator must immediately end voyage, cancel future voyages, and return to port if
COVID–19 identified onboard.
• Unchanged.
• Unchanged.

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.
(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–19-like Illness means ARI, ILI,
pneumonia, 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

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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, foreign-flagged, passengercarrying vessel operating in U.S. waters
with the capacity to carry 250 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.
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

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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 for 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 493
or CLIA-waived point-of-care testing or
the results of such testing. Testing must
be performed using tests that are
approved, cleared, or authorized for
emergency use by the U.S. Food and
Drug Administration (FDA) as specified
by CDC in technical instructions or
orders.
Operate or Operating in U.S. waters
means any action by a cruise ship
operator to bring or cause a cruise ship
to be brought into or transit in or
between any waterways (e.g., shifting
berths, moving to anchor, discharging
waste, making port, or embarking or
disembarking passengers or crew)
subject to the jurisdiction of the United
States.
Passenger means any individual being
transported or offered transport on
board a cruise ship who is not a crew
member, excluding U.S. government
personnel.
Passenger operations means any
action by a cruise ship operator to cause
passengers to embark or disembark a
cruise ship.
Person means any individual or
partnership, firm, company,
corporation, association, organization,
or other legal entity.
Physical distancing means
maintaining a distance of at least 6 feet,
or such other distance as specified by
CDC in technical instructions, between
one individual and another individual,
not gathering in groups, and avoiding
crowded places and mass gatherings.
Quarantine means measures taken by
a cruise ship operator to ensure the
onboard or onshore separation and
restriction of movement of passengers or

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crew who were potentially exposed to a
person with COVID–19 while that
person was considered infectious.
Responsible officials mean 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 trial
voyage 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.
U.S. waters means any international,
interstate, or intrastate waterways that
are subject to the jurisdiction of the
United States.
Background
Successful Resumption of Passenger
Operations in Collaboration With Cruise
Industry Partners
While cruising will never be a zerorisk activity for spread of COVID–19,
CDC has successfully worked with
cruise ship operators to manage this risk
and allow cruise ship operators to
resume passenger operations in a way
that mitigates the risk to crew members,
passengers, port personnel, and
communities. On October 30, 2020, CDC
issued the CSO, which resumes cruise
ship passenger operations in U.S. waters
through a phased approach. There are
four phases to the CSO:
• Mass crew testing and acquiring
onboard laboratory testing equipment
(Phase 1),
• Preparing for simulated and
revenue voyages (e.g., identifying
locations through port agreements to
provide for the quarantine or isolation,
respectively, of exposed and ill
passengers) (Phase 2A) and simulated
voyages to test onboard health and
safety protocols (Phase 2B),
• Applying for a COVID–19
Conditional Sailing Certificate (Phase 3);
and
• Restricted passenger revenue
voyages with public health precautions
(Phase 4).
Cruise ship operators that choose to
sail with 95% vaccinated crew and 95%
vaccinated passengers do not have to
conduct a simulated voyage prior to
applying for a COVID–19 Conditional
Sailing Certificate. Cruise ships that
have been operating restricted passenger
voyages with 95% vaccinated crew and
95% vaccinated passengers may also
transition to voyages with less than 95%
vaccinated passengers by conducting

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modified simulated voyage procedures
in lieu of a full simulated voyage.
Similarly, cruise ships that have been
conducting passenger operations in nonU.S. jurisdictions and intend to operate
in U.S. waters with less than 95%
vaccinated passengers after
repositioning to the U.S. may apply for
a COVID–19 Conditional Sailing
Certificate after conducting modified
simulated voyage procedures instead of
a full simulated voyage.
As of October 21, 2021, out of the 83
ships covered by the CSO, all have
acquired the onboard laboratory testing
equipment required by the CSO.11 As of
October 21, 2021, cruise ship operators
representing 16 brands—American
Queen Steamboat Company, Bahamas
Paradise Cruise Line, Carnival Cruise
Line, Celebrity Cruises, Crystal Cruises,
Disney Cruise Line, Holland America
Line, MSC Cruises, Norwegian Cruise
Line, Oceania Cruises, Princess Cruises,
Regent Seven Seas Cruises, Royal
Caribbean International, Silversea
Cruises, Ltd, Viking Cruises, and Virgin
Voyages—have submitted port
agreements to CDC’s Maritime Unit.
Additionally, CDC’s Maritime Unit has
been in discussions with cruise ship
operators representing 2 additional
brands—Azamara and ResidenSea—
with specific plans to operate ships
under the CSO. These port agreements
collectively cover 17 primary ports of
call: Cape Liberty Cruise Port (New
Jersey), Port of Baltimore, Port of
Boston, Port Canaveral, Port Everglades,
Port of Galveston, Port of Long Beach,
Port of Los Angeles, Port of Miami, Port
of New Orleans, Port of New York
(Manhattan), Port of Palm Beach, Port of
San Diego, Port of San Francisco, Port
of San Juan, Port of Seattle, and Port
Tampa Bay.12 13 CDC’s Maritime Unit
has approved port agreements for all 83
vessels covered by the CSO. Forty-eight
vessels have been approved for more
than one port.
11 The CSO does not require cruise ships to build
onboard laboratories. Rather, cruise ship operators
must procure an onboard testing unit about the size
of a desktop printer that easily fits within their
existing medical centers. This equipment allows
cruise ship operators to more easily test for the
virus that causes COVID–19, can be operated with
rudimentary training, and does not require a
professional laboratorian. Moreover, cruise ships’
pre-existing medical centers typically already have
different types of laboratory testing equipment on
board for diagnosing illness.
12 This list represents primary ports of call (i.e.,
home ports) and does not include secondary ports
of call, such as those in Alaska.
13 Primary ports of call approved for American
Queen Steamboat Company are not included in this
list because their ships are U.S.-flagged and do not
travel internationally. Therefore, their ships will no
longer be covered under the definition of ‘‘cruise
ship’’ in the temporary extension of the CSO.

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As of October 21, 2021, CDC’s
Maritime Unit has received and granted
18 requests from cruise ship operators to
conduct simulated voyages under the
CSO. As of October 21, 2021, CDC
Maritime Unit inspectors have
conducted 16 onboard inspections and
investigations of 15 ships, including a
second inspection on a ship that
transitioned from a simulated voyage to
a restricted passenger voyage. These
inspections ranged from one-day
inspections while the ship was in port,
to inspections that lasted several days
while the ship was underway. Because
cruise ship operators are restarting
operations mostly on ships that have not
carried passengers in U.S. waters since
March 2020, and with new crew
implementing new health and safety
protocols, there may be shortfalls in
training or in fully implementing
protocols. However, cruise ship
operators have worked closely with CDC
Maritime Unit inspectors to identify and
quickly remedy any observed lapses in
training or protocols.
Since the issuance of the CSO in
October 2020, CDC has worked
collaboratively with cruise lines to
ensure a safer restart of passenger
operations. As of October 21, 2021,
CDC’s Maritime Unit has received and
granted COVID–19 Conditional Sailing
Certificates to conduct revenue
passenger voyages to 53 ships operating
under the CSO. During numerous
regularly scheduled discussions, cruise
industry representatives have expressed
their desire to rebuild passenger
confidence and prove COVID–19 can be
successfully managed on board cruise
ships sailing in U.S. waters. Despite the
best efforts of cruise ship operators to
provide a safer and healthier
environment for crew and passengers,
public health concerns relating to the
ongoing pandemic, emergence of
variants of concerns such as the Delta
variant, and breakthrough infections in
fully vaccinated persons highlight the
need to temporarily extend the CSO,
particularly as we see high levels of
transmission in the United States and
globally, including in countries with
high rates of vaccination, such as the
United Kingdom and Israel.14 15
Current State of COVID–19 Pandemic
As of October 21, 2021, there have
been almost 241 million cases of
COVID–19 globally, resulting in over
4,900,000 deaths.16 Over 45 million
cases have been identified in the United
14 https://covid19.who.int/region/euro/country/

gb.
15 https://covid19.who.int/region/euro/country/il..
16 https://covid19.who.int/.

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States, with new cases reported daily,
and over 730,000 deaths attributed to
the disease.17 Forecasting teams predict
numbers of deaths, hospitalizations, and
cases using different types of data (e.g.,
COVID–19 data, demographic data,
mobility data), methods, and estimates
of the impacts of interventions (e.g.,
physical distancing, use of face masks).
A renewed surge in cases in the United
States began in early July 2021; case
counts rose from 19,000 cases per day
on July 1, 2021 to over 150,000 cases per
day on August 31, 2021. During the
pandemic, cases have tended to surge in
waves with 4 waves as of October
2021.18 Therefore, additional surges of
cases and deaths could be expected to
occur. Similar to seasonal epidemics of
influenza and other respiratory viruses,
surges in cases, hospitalizations, and
deaths from COVID–19 could also be
expected to occur in winter as more
people spend time indoors due to
inclement weather.
The virus that causes COVID–19
spreads very easily and sustainably
between people, particularly those who
are in close contact with one another
(within about 6 feet, but occasionally
over longer distances). COVID–19
spreads when an infected person
breathes out droplets and very small
particles that contain the virus. These
droplets and particles can be breathed
in by other people or land on their eyes,
noses, or mouth. Individuals without
symptoms can also spread the virus.
Among adults, the risk for severe illness
from COVID–19 increases with age, with
older adults at highest risk. Severe
illness means that persons with COVID–
19 may require hospitalization,
intensive care, or a ventilator to help
them breathe, and may be fatal. People
of any age with certain underlying
medical conditions (e.g., cancer, obesity,
serious heart conditions, diabetes) are at
increased risk for severe illness from
COVID–19.19
Emergence of Variants
Variants of SARS–CoV–2, the virus
that causes COVID–19, are expected to
continue to emerge. Some will emerge
and disappear, and others will emerge
and continue to spread and may replace
previous variants.20 While it is known
and expected that viruses constantly
change through mutation leading to the
17 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
18 https://www.cdc.gov/coronavirus/2019-ncov/
science/forecasting/mathematical-modeling.html.
19 https://www.cdc.gov/coronavirus/2019-ncov/
need-extra-precautions/people-with-medicalconditions.html.
20 https://www.cdc.gov/coronavirus/2019-ncov/
variants/variant-info.html#Concern.

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emergence of new variants, the Delta
variant is particularly concerning
because it causes more infections and
spreads faster than earlier forms of
SARS–CoV–2.21 It has rapidly become
the predominant strain in the United
States, estimated to account for 99.7%
of U.S. cases 22 and has been reported in
193 places 23 worldwide as of October
20, 2021.
Recent studies have also
demonstrated that some fully vaccinated
people exposed to the Delta variant can
become infected, and those persons can
be contagious and spread the illness to
others, although their infectious period
appears to be shorter compared to
people who are not fully
vaccinated.24 25 26 Delta has been shown
to result in higher viral loads in infected
people, and spreads twice as easily from
one person to another, compared to
earlier strains. The ultimate concern is
the emergence of a ‘‘variant of high
consequence’’ that undermines existing
public health defenses by substantially
decreasing the effectiveness of available
testing, treatments, and vaccines against
severe or deadly disease.27 While such
a variant of high consequence has not
yet been identified, so long as new
variants of SARS–CoV–2 continue to
emerge and circulate, the potential for
such a variant to arise remains a
possibility.
Availability of Vaccines and Delta
Variant
COVID–19 vaccines are now widely
available in the United States, and
vaccination is currently recommended
for all people 12 years of age and older.
As of October 21, 2021, over 189 million
people in the United States (66.9% of
21 Li B, Deng A, Li K, et al. Viral Infection and
Transmission in a Large Well-Traced Outbreak
Caused by the Delta SARS–CoV–2 Variant.
medRxiv. 2021 Jul 12; https://doi.org/10.1101/
2021.07.07.21260122.
22 https://covid.cdc.gov/covid-data-tracker/
#variant-proportions.
23 https://covid.cdc.gov/covid-data-tracker/
#global-variant-report-map.
24 Brown CM, Vostok J, Johnson H, et al. Outbreak
of SARS–CoV–2 Infections, Including COVID–19
Vaccine Breakthrough Infections, Associated with
Large Public Gatherings—Barnstable County,
Massachusetts, July 2021. MMWR Morb Mortal
Wkly Rep 2021;70:1059–1062. DOI: http://
dx.doi.org/10.15585/mmwr.mm7031e2.
25 Dougherty K, Mannell M, Naqvi O, Matson D,
Stone J. SARS–CoV–2 B.1.617.2 (Delta) Variant
COVID–19 Outbreak Associated with a Gymnastics
Facility—Oklahoma, April–May 2021. MMWR
Morb Mortal Wkly Rep 2021;70:1004–1007. DOI:
http://dx.doi.org/10.15585/mmwr.mm7028e2.
26 CDC: Delta Variant: What We Know about the
Science.
27 SARS–CoV–2 Variant Classifications and
Definitions, Centers for Disease Control and
Prevention, https://www.cdc.gov/coronavirus/2019ncov/variants/variant-info.html#Concern (last
updated September 23, 2021).

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the population 12 years or older) have
been fully vaccinated and over 219
million people in the United States
(77.4% of the population 12 years or
older) have received at least one dose.28
The three COVID–19 vaccines
approved or authorized in the United
States are highly effective at preventing
severe disease and death from COVID–
19, including against the Delta
variant.29 30 But some fully vaccinated
people will still become infected
(breakthrough infection) and experience
illness. While vaccination has shown to
lower the risk of severe COVID–19 cases
or death, people who are vaccinated and
become infected with the Delta variant
may still transmit the virus to others,
although vaccinated people appear to be
infectious for a shorter period.31 32 33 34
This evidence coupled with people
getting vaccinated at a slower rate in the
United States, and the extreme
transmissibility of the Delta variant has
resulted in rapidly rising numbers of
COVID–19 cases, primarily and
disproportionately affecting those not
fully vaccinated.

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Justification for Temporary Extension
of CSO
Despite the best efforts of cruise ship
operators to provide a safer and
healthier environment for crew and
passengers, including operating ships
with high percentages of vaccinated
persons onboard, outbreaks of COVID–
19 have continued to occur, many
involving breakthrough infections in
fully vaccinated persons. Between June
7–30, 2021, a cruise ship operator
28 https://covid.cdc.gov/covid-data-tracker/
#vaccinations_vacc-total-admin-rate-total.
29 Bernal JL, Andrews N, Gower C, et al.
Effectiveness of Covid–19 Vaccines against the
B.1.617.2 (Delta) Variant. N Engl J Med. 2021 Jul
21;doi:10.1056/NEJMoa2108891external icon.
30 Thompson MG, Burgess JL, Naleway AL, Tyner
H, Yoon SK, Meece J, et al. Prevention and
Attenuation of Covid–19 with the BNT162b2 and
mRNA–1273 Vaccines. N Engl J Med.
2021;385(4):320–9.
31 Mlcochova P, Kemp S, Dhar S, et al. SARS–
CoV–2 B.1.617.2 Delta Variant Emergence and
Vaccine Breakthrough. Research Square Platform
LLC. 2021 Jun 22; doi:10.21203/rs.3.rs-637724/
v1external icon.
32 Musser JM, Christensen PA, Olsen RJ. et al.
Delta Variants of SARS–CoV–2 Cause Significantly
Increased Vaccine Breakthrough COVID–19 Cases
in Houston, Texas. medRxiv. 2021 Jul 22; https://
org/10.1101/2021.07.07.21260122.
33 Brown CM, Vostok J, Johnson H, et al. Outbreak
of SARS–CoV–2 Infections, Including COVID–19
Vaccine Breakthrough Infections, Associated with
Large Public Gatherings—Barnstable County,
Massachusetts, July 2021. MMWR Morb Mortal
Wkly Rep. ePub: 30 July 2021; https://www.cdc.gov/
mmwr/volumes/70/wr/mm7031e2.htm.
34 Chia PY, Ong SWX, Chiew CJ, et al. Virological
and serological kinetics of SARS–CoV–2 Delta
variant vaccine-breakthrough infections: a multicenter cohort study. 2021;doi:doi.org/10.1101/
2021.07.28.21261295.

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identified 21 laboratory-confirmed
COVID–19 cases onboard one of its
ships, with the majority of cases among
fully vaccinated persons. CDC’s
Maritime Unit assisted the cruise ship
operator with the investigation to
prevent further spread of the virus on
board. In addition, the Maritime Unit
collaborated with CDC’s COVID–19
Laboratory Task Force to have
specimens from this outbreak
genetically sequenced to identify if a
variant of concern was the cause.
Results showed that the outbreak was in
fact, due to the highly transmissible
Delta variant.
As cruise ship operators continue to
embark new crew in anticipation of
more passenger revenue voyages in the
U.S., cases of COVID–19 among crew
have been reported, highlighting the
continued need for public health
management of cases to mitigate this
risk. The resumption of passenger
voyages in the U.S. has led to the
introduction and sustained transmission
of COVID–19 among cruise ships,
despite high vaccination rates among
both crew and passengers. With an
increase in traveler volume, cruise ships
have experienced increased numbers of
COVID–19 cases among passengers and
crew. Between June 26–October 21,
2021, 1,359 laboratory confirmed cases
of COVID–19 were reported to CDC by
cruise ships following the CSO.35
Several large outbreaks on cruise
ships are highlighted below.
• On July 24, 2021, one symptomatic
passenger who tested positive for
COVID–19 on a cruise ship (Cruise Ship
A) was epidemiologically linked to 20
additional laboratory-confirmed cases of
COVID–19 over two voyages, including
2 passengers and 18 crew. The COVID–
19 vaccination rate on this ship ranged
between 99.8–100% for crew and 96.4–
97.5% for passengers.
• Between July 24–August 28, a
cruise ship (Cruise Ship B) reported 58
laboratory-confirmed COVID–19 cases
among passengers and crew. The
COVID–19 vaccination rate on this ship
ranged between 96.8–97.7% for
passengers and averaged 100% for crew.
• Between July 29–31, 2021, three
symptomatic passengers tested positive
for COVID–19 on a cruise ship (Cruise
Ship C). Contact tracing and testing
identified an additional 12 laboratoryconfirmed cases of COVID–19,
including 10 passengers and 2 crew.
This was a highly vaccinated ship with
35 This number does not include newly
embarking crew who tested positive for SARS–
CoV–2 prior to or during their embarkation
quarantine period, or passengers who tested
positive for SARS–CoV–2 at embarkation and did
not board the ship.

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100% of crew and an average of 97% of
passenger fully vaccinated.
• Between July 26–August 6, a cruise
ship (Cruise Ship D) reported 7
laboratory-confirmed COVID–19 cases
among passengers and crew. The
COVID–19 vaccination rate on this ship
was 100% for crew and ranged between
96.8–97.7% for passengers.
• Between August 19–September 7, a
cruise ship (Cruise Ship E) reported 105
laboratory-confirmed COVID–19 cases
among passengers and crew on a total of
four consecutive voyages. This was a
highly vaccinated ship with 100% of
crew and an average of 97% of
passenger fully vaccinated at the time
on the voyage(s).
• Between August 21–September 7, a
cruise ship (Cruise Ship F) reported a
total of 112 laboratory-confirmed
COVID–19 cases among passengers and
crew on four consecutive voyages
despite the ships’ 100% vaccination rate
for persons onboard.
While high vaccination rates onboard
these cruise ships likely explain why
onboard medical center resources have
not been overwhelmed, the number of
hospitalizations and medical
evacuations due to COVID–19 or CLI
have increased since passenger
operations resumed. Between June 26–
October 21, 2021, 49 hospitalizations
and 38 medical evacuations for COVID–
19 or CLI were reported to CDC.
Despite the implementation of strict
protocols by cruise ship operators to
prevent the introduction of COVID–19
from passengers, ensuring passengers
are uninfected at embarkation has
proven difficult. There have been
several instances of passengers’ being
symptomatic on the day of embarkation
and denying symptoms to the cruise
line, or passengers’ being symptomatic
for several days on board the ship before
reporting their symptoms to the medical
center. These situations have led to
complex contact tracing investigations,
due to the large number of contacts
exposed between presumed onset of
infectiousness and when infection was
identified and the passenger isolated.
For example, a passenger on a cruise
ship (Cruise Ship F), who was fully
vaccinated and had tested negative for
COVID–19 three days before boarding,
boarded the ship while symptomatic for
COVID–19, but denied having
symptoms. The passenger died three
days after boarding for reasons related to
COVID–19. This led to CDC and the
cruise line taking the following public
health actions:
• Contact tracing to identify exposed
persons, which included interviews of
passengers and crew, review of security
footage, and analysis of wearable

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technology and other relevant location
data;
• Notifications to close contacts to
advise them to monitor for symptoms,
and to federal, state, and local partners
in two states;
• Screening testing to identify those
who could have been infected;
• Isolation for close contacts who
tested positive for COVID–19; and
• Quarantine for close contacts who
tested negative for COVID–19 but could
have still developed the illness during
the incubation period.
Based on these time-sensitive and
labor-intensive public health actions,
the cruise line identified over 30 close
contacts from one infected passenger.
Cruise ship voyages from the U.S. also
include itineraries to countries that have
low vaccination rates but are reopening
to international tourism. These
countries may have limited testing
capabilities for their populations, which
could restrict their ability to identify
COVID–19, including variants of
concern. Cruise ship travel to these
countries risks potentially introducing
additional variants of concern into the
United States. Based on CDC’s
assessment of risk and issuance of
Travel Health Notices for international
destinations,36 travelers may be at
increased risk for getting and spreading
COVID–19 variants in the following
countries where cruise ships intend to
sail, per published itineraries: Aruba,
the Bahamas, Barbados, Bermuda,
Belize, Bonaire, Curac
¸ao, Haiti,
Honduras, Jamaica, Mexico, Saint Kitts
and Nevis, Sint Maarten, and Turks and
Caicos Islands.37 Accordingly, based on
these risks and information available to
CDC, the CSO continues to represent the
best way of protecting the public’s
health by mitigating COVID–19
transmission onboard cruise ships and
into the United States.

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Findings and Immediate Action
The ongoing COVID–19 pandemic,
emergence of variants of concerns,
including the Delta variant,
breakthrough infections in fully
vaccinated persons, and possible surges
of additional cases, hospitalizations,
and deaths in the U.S. and in countries
to which cruise ships travel support the
CSO’s temporary extension to mitigate
36 How CDC Determines the Level for COVID–19
Travel Health Notices.
37 COVID–19 in Aruba, COVID–19 in the
Bahamas, COVID–19 in Barbados, COVID–19 in
Belize, COVID–19 in Bermuda, COVID–19 in
Bonaire, COVID–19 in Curac¸ao, COVID–19 in Haiti,
COVID–19 in Honduras, COVID–19 in Jamaica,
COVID–19 in Mexico, COVID–19 in Saint Kitts and
Nevis, COVID–19 in Sint Maarten, COVID–19 in
Trinidad and Tobago, and COVID–19 in the Turks
and Caicos Islands.

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the risk of further COVID–19
introduction, transmission, and spread
both onboard cruise ships and into U.S.
communities.
Finding of Inadequate Local Control
Under 42 CFR 70.2
The cruise ships subject to this Order
are all foreign-flagged and operate on
international itineraries. State and local
health departments consider public
health on cruise ships as primarily
subject to federal jurisdiction and do not
routinely exercise oversight or control
over cruise ship operations nor maintain
maritime public health programs,
particularly when such cruise ships
employ mostly foreign crews and
operate in international waters subject
to the jurisdiction of the United States.
Many state and local health departments
are also currently engaged in response
activities relating to the COVID–19
pandemic, and do not have the time,
money, or public health resources to
dedicate staff and programs to maritime
public health activities. Further, based
on legal authority at 42 CFR 71.31(b),
CDC is the only government entity that
may impose public health conditions on
cruise ships operating in international
waters if those ships plan to return to
operating in U.S. waters. Furthermore,
U.S. Coast Guard, not state and local
public health departments, is the only
entity that routinely conducts
emergency medical evacuations at sea,
including for persons with COVID–19.
Accordingly, under 42 CFR 70.2, the
Director determines that based on
jurisdictional limitations and other
factors, the measures taken by state and
local public health authorities in U.S.
jurisdictions where foreign-flagged
cruise ships port or travel on
international itineraries and do not
routinely exercise public health
jurisdiction nor maintain maritime
public health programs that conduct
surveillance, inspections, investigations,
and management for diseases of public
health concern on board cruise ships
have been and are insufficient to
prevent the spread of COVID–19 into
and among U.S. states and territories.38
38 These jurisdictions include the following U.S.
states: Alabama, Alaska, California, Delaware,
Florida, Georgia, Hawaii, Illinois, Louisiana, Maine,
Maryland, Massachusetts, Michigan, Minnesota,
Mississippi, New Hampshire, New Jersey, New
York, North Carolina, Ohio, Oregon, Pennsylvania,
Rhode Island, South Carolina, Texas, Virginia, and
Washington State. These jurisdictions also include
the following U.S. territories: American Samoa,
Guam, Northern Mariana Islands, Puerto Rico, and
the U.S. Virgin Islands. CDC is not currently aware
of any states or U.S. territories operating a maritime
public health program that would displace the CSO.

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Statement of Good Cause Under the
Administrative Procedure Act (‘‘APA’’)
COVID–19 cases, hospitalizations,
and deaths continue to increase,
especially in areas with higher levels of
community transmission and lower
vaccination coverage.39 Furthermore,
while pediatric cases and
hospitalizations have decreased in
recent weeks following a previous
increase, cases and hospitalizations
could surge again.40 Based on the
rapidly increasing cases and spread of
the Delta variant and other variants of
SARS–CoV–2, and to reduce
introduction and spread of these and
future SARS–CoV–2 variants into the
United States, including a potential
variant of high consequence, at a time
when cruise ship travel has resumed,
CDC must take quick and targeted action
to further curtail the spread of Delta and
other new virus variants into the United
States.
The Director continues to find
evidence to support a reasonable belief
that cruise ships are or may be infected
or contaminated with a quarantinable
communicable disease.41 This
reasonable belief is based on
information from epidemiologic and
other data.42 As a result, absent
measures of the type specified in the
39 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
40 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
41 The list of federally quarantinable
communicable diseases as defined by Executive
Order includes severe acute respiratory syndromes,
defined as diseases that are associated with fever
and signs and symptoms of pneumonia or other
respiratory illness, are capable of being transmitted
from person to person, and that either are causing,
or have the potential to cause, a pandemic, or, upon
infection, are highly likely to cause mortality or
serious morbidity if not properly controlled. This
definition does not apply to influenza. See
Executive Order 13295 (April 4, 2003), as amended
by Executive Orders 13375 (April 1, 2005), 13674
(July 31, 2014), and 14047 (September 17, 2021).
CDC has determined that COVID–19 meets the
definition of a severe acute respiratory syndrome
and therefore is a quarantinable communicable
disease.
42 Multiple studies have confirmed that COVID–
19 transmission rates onboard cruise ships are
higher than in other settings. Kordsmeyer, A.-C.;
Mojtahedzadeh, N.; Heidrich, J.; Militzer, K.; von
Mu¨nster, T.; Belz, L.; Jensen, H.-J.; Bakir, S.;
Henning, E.; Heuser, J.; et al. Systematic Review on
Outbreaks of SARS–CoV–2 on Cruise, Navy and
Cargo Ships. Int. J. Environ. Res. Public Health
2021, 18, 5195. https://doi.org/10.3390/
ijerph18105195; 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. https://doi.org/
10.1093/jtm/taaa030; 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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Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
CSO, persons on board or seeking to
board cruise ships may likely be or
would likely become infected with or
exposed to the virus that causes COVID–
19 by virtue of being on board at a time
when the virus, including the highly
transmissible Delta variant, continues to
circulate globally and in the U.S.
Additionally, persons infected on cruise
ships would be likely to transmit
COVID–19 to U.S. communities by
traveling interstate after disembarking a
cruise ship.
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). If this Order
qualifies as a rule under the APA, notice
and comment and a delay in effective
date are not required because good
cause exists to dispense with prior
public notice and the opportunity to
further comment on this Order.
Considering the public health
emergency caused by COVID–19,
including the Delta variant, based on,
among other things, its potential for
spread on board cruise ships and
potential to cause breakthrough
infections in vaccinated persons, 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. 5 U.S.C.
553(b)(B), (d)(3).
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 under Subtitle E of the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121,
SBREFA), 5 U.S.C. 804(2), but there
would not be a delay in its effective date
under 5 U.S.C. 808(2) as the agency has
invoked the good cause provision of the
APA. As explained in this Order, during
the pandemic, cases have tended to
surge in waves with 4 waves as of
October 2021.43 Therefore, additional
surges of cases and deaths can be
expected. The winter season (November
through January) has historically been
the most active cruising season in the
Caribbean and Central America,
involving travel to countries currently
listed by CDC as being under COVID–19
travel health notices where cruise ship
travelers may be at increased risk for
acquiring and subsequently introducing
COVID–19 variants into the U.S.
Additionally, cruise ship operators have
informed CDC of their intended plans to
increase the number of ships operating
43 https://www.cdc.gov/coronavirus/2019-ncov/
science/forecasting/mathematical-modeling.html.

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in U.S. waters this fall and winter.
Accordingly, in light of the rapidly
evolving public health situation and
expected increase in winter cruising
activity, pausing the operation and
enforcement of the CSO to allow for a
notice and comment period would be
impracticable and contrary to the public
interest.
While it was not feasible based on the
rapidly evolving pandemic and
emergence of variants of concern to seek
full notice and comment through
rulemaking, CDC solicited specific
feedback from cruise ship operators and
other partners relating to the measures
in this temporary CSO extension.
Unfortunately, CDC received low
response rate to its solicitation (n=15).
Almost three quarters of the
respondents were cruise industry
representatives (n=11) and the
responses may have underrepresented
non-cruise stakeholder partners (such as
state and local health departments,
seaport partners, and U.S. government
interagency partners). Therefore, CDC
acknowledges that further solicitation
and feedback are warranted before
existing elements of the CSO are
maintained, modified, or rescinded as
part of any future voluntary program.
Based on feedback received, the
majority of respondents agreed on the
importance of COVID–19 industry-wide
standards including:
• Surveillance protocols,
• medical protocols, capabilities, and
supplies for managing patients on
board, and
• preventive measures & public
health interventions (e.g., mask use,
physical distancing, cleaning and
disinfection, infection prevention and
control plans).
The majority of respondents also
agreed on the importance of continued
communication and close collaboration
between CDC and cruise lines,
including through regularly scheduled
executive session calls between cruise
lines, CDC, and interagency
representatives to exchange information
and share ideas; regularly scheduled
technical assistance calls between CDC’s
Maritime Unit and cruise lines’ public
health personnel; and ad hoc outbreak
assistance calls between CDC’s Maritime
Unit and cruise lines’ medical and
public health staff.
While most cruise industry
respondents disagreed that port
agreements were useful for the
resumption of passenger operations,
respondents were divided as to whether
individual components of the port
agreements (e.g., medical care, housing,
and vaccination) were important for
future cruise operations. However,

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based on previous feedback from state
and local health departments and
seaport partners, CDC believes that
emergency response planning is an
important element of COVID–19 health
and safety protocols that should be a
part of future cruise ship operations.
The exact elements of such emergency
response planning would be the subject
of further discussion and information
sharing as part of any future voluntary
program between CDC and the cruise
ship industry.
Most cruise industry respondents also
disagreed that CDC’s Cruise Ship Color
Status web page was useful for
communicating information about
COVID–19 on cruise ships in U.S.
jurisdictions. However, CDC believes it
is important to be transparent and
continue to advise the public about
COVID–19 conditions on board cruise
ships so that passengers can make better
informed decisions based on their
preexisting medical conditions and risk
of severe illness. How best to inform the
public about COVID–19 conditions on
board cruise ships would similarly be
the subject of further discussion and
information sharing as it relates to any
future voluntary program.
The interest of cruise ship operators
in participating in a future voluntary
program to detect, mitigate, and control
the spread of COVID–19 during future
cruise ship operations is also difficult to
gauge based on this limited initial
feedback. Of the 11 cruise industry
respondents, 4 indicated they would be
interested in such a program and 7
indicated that they would not be. Based
on written comments received to this
question, some cruise ship operators
expressed reticence to respond in the
affirmative in the absence of additional
details regarding the scope and
parameters of such a voluntary program.
Regardless, CDC wishes to stress that
cruise ship participation in any future
voluntary program would not be
mandated; the scope and parameters of
such a program would be subject to
further discussion and information
sharing; and cruise ship operators
would be free to develop alternative
pathways of detecting, mitigating, and
controlling the spread of COVID–19
onboard cruise ships.
Accordingly, CDC will use the
additional time provided by this
temporary extension to better gauge
interest in a voluntary program and
continue to explore alternative
pathways to detect, mitigate, and
control the spread of COVID–19
onboard cruise ships. During this
temporary extension period, CDC
intends to solicit additional feedback
from the cruise industry, state and local

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health departments, seaport partners,
and U.S. government interagency
partners as may be needed to explore
interest in and develop a voluntary
program to assist the cruise ship
industry to detect, mitigate, and control
the spread of COVID–19 onboard cruise
ships for those cruise ship operators
who may wish to be involved in such
a program.
Severability of Provisions
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.
Federal Preemption
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.
Enforceability
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. While this Order
may be enforced and CDC reserves the
right to enforce in appropriate
circumstances through criminal
penalties, CDC does not intend to rely
primarily on these criminal penalties
but instead anticipates continued widespread voluntary compliance from
cruise ship operators as well as support
from U.S. Coast Guard.
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 as defined in this Order
for the period described below, it is
ordered:

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Framework for Conditional Sailing
Order
Purpose and Scope
(a) Purpose. The purpose of this
framework is to prevent the further
introduction, transmission, and spread
of COVID–19 into and throughout the
United States via cruise ships. These
requirements are in addition to other
requirements in regulations or actions
taken by HHS/CDC to prevent the
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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 foreign-flagged cruise ship in
U.S. waters and to any person operating
a foreign-flagged 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.
General Prohibition on a Cruise Ship
Operator Commencing or Continuing
Passenger Operations Without a
COVID–19 Conditional Sailing
Certificate
(a) A cruise ship operator subject to
this Order must meet the requirements
of this framework as a condition of
obtaining or retaining controlled free
pratique for operating a cruise ship in
U.S. waters or if the cruise ship operator
is operating a cruise ship outside of U.S.
waters and intends for the ship to return
to operating in U.S. waters while this
Order remains in effect. These
requirements must additionally be met
as a condition of obtaining or retaining
controlled free pratique for conducting
a simulated voyage or applying for a
COVID–19 Conditional Sailing
Certificate.
(b) 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.
(c) A cruise ship operator shall not
violate the terms or conditions of a
COVID–19 Conditional Sailing
Certificate issued pursuant to this
framework.
(d) As a condition of obtaining or
retaining a COVID–19 Conditional

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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.
Requirements for COVID–19 Response
Plan for Cruise Ship Operators
Operating or Intending To Operate
Cruise Ships in U.S. Waters 44
(a) Cruise ships operating or intending
to operate in U.S. waters must have a
COVID–19 response plan that includes
the following components:
(1) Terminology and use of definitions
that align with how CDC uses and
defines the following terms: ‘‘confirmed
COVID–19,’’ ‘‘COVID–19-like illness,’’
‘‘close contact,’’ ‘‘fully vaccinated for
COVID–19,’’ and ‘‘isolation’’ and
‘‘quarantine’’ (including timeframes for
isolation and quarantine).
(2) Protocols for on board surveillance
of passengers and crew with COVID–19
and COVID–19-like-illness.
(3) Protocols for training all crew on
COVID–19 prevention, mitigation, and
response activities.
(4) Protocols for on board isolation
and quarantine, including how to
increase capacity in case of an outbreak.
(5) Protocols for COVID–19 testing
that aligns with CDC technical
instructions.
(6) Protocols for onboard medical
staffing—including number and type of
staff—and equipment in sufficient
quantity to provide a hospital level of
care (e.g., ventilators, face masks,
personal protective equipment) for the
infected without the immediate need to
rely on shoreside hospitalization.
(7) Procedures for disembarkation of
passengers who test positive for COVID–
19.
(b) The cruise ship operator has
observed and will continue to observe
all elements of its COVID–19 response
plan including following the most
current CDC recommendations and
guidance for any public health actions
related to COVID–19.

44 COVID–19 response plans were formerly
referred to as ‘‘No Sail Order’’ response plans.
Cruise ship operators that previously submitted a
signed ‘‘Acknowledgment of No Sail Order
Response Plan Completeness and Accuracy’’ to CDC
have fulfilled the requirements of this section and
do not need to re-submit a COVID–19 response
plan.

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Requirements for COVID–19 Testing
Capabilities and Reporting for Cruise
Ship Operators Operating or Intending
To Operate Cruise Ships in U.S.
Waters 45
(a) Cruise ships operating or intending
to operate in U.S. waters must have
onboard testing capabilities as directed
by CDC in technical instructions or
orders to test all symptomatic crew and
passengers for COVID–19 and their
close contacts. These capabilities
include having onboard rapid nucleic
acid amplification test (NAAT) point-ofcare equipment that meets the
requirements specified by CDC in
technical instructions or orders.46 This
testing instrument must be authorized
by FDA for use in a CLIA-waived
setting, have been evaluated on the FDA
reference panel for SARS–CoV–2,47
allow for specimen-to-instrument
transfer in a way that minimizes the risk
of contamination, and possess a limit of
detection (LoD) value ≤18,000 NDU/ml.
(b) 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 the
CSO 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 14 days
preceding those ships’ expected arrival
in U.S. waters and continue to submit
the EDC form after the ships’ entering
U.S. waters or, alternatively, arrange for
such appropriate shoreside or shipbased testing of passengers and crew as
directed by CDC with subsequent
submission of the EDC form after the
ships’ arrival.
(c) The cruise ship operator has
arranged for and submitted and will
continue to arrange for and submit such
COVID–19 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
45 This section does not impose new requirements
on cruise ship operators but merely restates
requirements that cruise ship operators previously
fulfilled during Phase 1 of the CSO. These
requirements were previously published under the
section ‘‘Requirements for Protection of Crew for
Cruise Ship Operators Operating or Intending to
Operate Cruise Ships in U.S. Waters.’’
46 Technical Instructions for Mitigation of
COVID–19 Among Cruise Ship Crew ⎢ Quarantine
⎢ CDC.
47 For tests that do not have the FDA reference
panel available, tests will be accepted using
sensitivity data ≥95% from clinical samples as
indicated in the manufacturer’s instructions for use.

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remains in effect. Routine COVID–19
screening testing of all crew must be
conducted at such other intervals as
required by CDC in technical
instructions or orders. CDC may
conduct oversight of specimen
collection, testing, and laboratory
procedures, as necessary.
(d) CDC may issue additional
requirements through technical
instructions or orders relating to a cruise
ship operator’s processes and
procedures for protection of crew.
Agreement With Port and Local Health
Authorities 48
(a) As a condition of obtaining or
retaining controlled free pratique for
conducting a simulated voyage or
obtaining and retaining a COVID–19
Conditional Sailing Certificate, a cruise
ship operator must document the
approval of all U.S. port and local
health authorities where the ship
intends to dock or make port during a
simulated voyage or a restricted
passenger voyage. Such written
approval must include the following:
(1) A medical care agreement between
the cruise ship operator and health care
entities, addressing evacuation to
onshore hospitals for passengers and
crew in need of care, in accordance with
CDC technical instructions and orders.49
(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
that takes into consideration the public
health response resources of the
jurisdiction in the event of a COVID–19
outbreak, a plan and timeline for
vaccination of cruise ship crew prior to
resuming passenger operations, and
vaccination strategies to maximally
protect passengers and crew from
introduction, amplification, and spread
of COVID–19 in the maritime
environment and in land-based
communities.
(b) In lieu of documenting the
approval of all local health authorities
of jurisdiction, the cruise ship operator
may instead submit to CDC a signed
48 Cruise ship operators that previously submitted
and had their port and local health agreements
accepted by CDC are not required to take any
further action under this section if such agreements
continue to remain in effect.
49 https://www.cdc.gov/quarantine/cruise/
instructions-local-agreements.html.

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statement from a local health authority,
on the health authority’s official
letterhead, indicating that the health
authority has declined to participate in
deliberations and/or sign the port
agreement, i.e., a ‘‘Statement of NonParticipation.’’
(c) In documenting the approval of all
U.S. port and local health authorities
where the ship intends to dock or make
port during simulated voyages or
restricted passenger voyages, the cruise
ship operator may enter into a multiport agreement (as opposed to a single
port agreement) provided that all
relevant port and local health
authorities (including the state health
authorities) are signatories to the
agreement.
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 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: 50
(1) The cruise ship operator must
inform volunteer passengers in writing
that they are participating in a
simulation of health and safety
protocols for purposes of simulating a
cruise ship voyage.
(2) All volunteer passengers must be
at least twelve 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. The cruise ship operator must
document the informed consent of all
adult participants in writing. If any
minors are to participate in the
simulation then the informed consent of
a parent or guardian, and the written
assent of the minor must also be
documented in writing. All persons
younger than eighteen years old must be
fully vaccinated against COVID–19 as a
50 https://www.cdc.gov/quarantine/cruise/tisimulated-voyages-cso.html.

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condition of participation on a
simulated voyage.
(4) 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.
(5) The cruise ship operator must
conduct laboratory testing of volunteer
passengers, as directed in CDC technical
instructions or orders, prior to
embarking volunteer passengers on a
simulated voyage.
(6) 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.
(7) The cruise ship operator must
meet standards for hand hygiene,
facemasks, and physical distancing for
passengers and crew, as well as ship
sanitation, as may be required by CDC
technical instructions or orders.
(8) The cruise ship operator must
modify meal service and entertainment
venues to facilitate physical distancing
during the simulated voyage.
(9) 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.
(10) The cruise ship operator must
immediately conduct laboratory testing
of any passengers and crew who report
illness consistent with COVID–19

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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.
(11) CDC may require the cruise ship
operator to immediately end the
simulated voyage and take other action
to protect the health and safety of
volunteer passengers and crew if during
the simulation a threshold of COVID–19
cases, as determined by CDC in
technical instructions, is met or
exceeded.51
(12) 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.
(13) 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 require that the cruise ship
operator modify its practices or
procedures 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 must 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.
This written notice must be submitted at
least 5 business days prior to the date
on which the cruise ship operator
proposes to conduct the simulation.
(c) A cruise ship operator shall not
apply for approval to conduct a
51 During simulated passenger voyages, this
threshold is currently met when 1.5% of COVID–
19 cases is detected in passengers or 1.0% of
COVID–19 cases is detected in crew. This threshold
may be modified based on lessons learned from
simulated voyages or restricted passenger voyages,
the evolution of the pandemic, or other factors. If
a simulated voyage is ended early to protect health
and safety, CDC will consult with the cruise ship
operator regarding any deficiencies to be noted in
the operator’s action-action report and how such
deficiencies are to be corrected prior to approving
an application for a COVID–19 Conditional Sailing
Certificate.

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simulated voyage until all of CDC’s
requirements relating to onboard
laboratory capacity and screening
testing of crew in U.S. waters have been
satisfied. The cruise ship operator’s
responsible officials must sign the
application for permission to conduct a
simulation and certify that all of CDC’s
requirements relating to onboard pointof-care laboratory capabilities and
screening testing of crew onboard cruise
ships in U.S. waters have been satisfied.
(d) CDC will respond to the written
notice and request for approval to
conduct a simulation in writing in a
timely manner. CDC may deny the
request to conduct a simulation if the
cruise ship operator is not in
compliance with any provision of this
framework, technical instructions, or
orders, or if in CDC’s determination the
simulation does not provide adequate
safeguards to minimize the risk of
COVID–19 for all participants.
(e) CDC may conduct such oversight
and inspection of simulated voyages as
it deems necessary in its discretion,
including through in-person or remote
means allowing for visual observation.
(f) CDC may issue additional
requirements through technical
instructions or orders relating to a cruise
ship operator’s processes and
procedures for conducting and
evaluating a simulated voyage prior to
applying for a COVID–19 Conditional
Sailing Certificate.
(g) In lieu of conducting a simulated
voyage, cruise ship operator responsible
officials, at their discretion, may sign
and submit to CDC an acknowledgement
that 95% of crew (excluding any newly
embarking crew in quarantine) are fully
vaccinated and submit to CDC a clear
and specific vaccination plan and
timeline to limit cruise ship sailings to
95% of passengers who have been
verified by the cruise ship operator as
fully vaccinated prior to sailing.
(h) In lieu of conducting a simulated
voyage under this paragraph, cruise ship
operators, at their discretion, may
choose to follow the procedures for
modified simulated voyages if
transitioning to voyages with less than
95% of passengers fully vaccinated or if
operating cruise ships outside of U.S.
waters and intending to operate with
less than 95% of passengers fully
vaccinated after repositioning to U.S.
waters.
Procedures in Lieu of Conducting a
Simulated Voyage for Cruise Ship
Operators Transitioning to Voyages
With Less Than 95% of Passengers Fully
Vaccinated
(a) Cruise ships that have been
operating restricted passenger voyages

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under an acknowledgement by the
cruise ship operator’s responsible
officials that they will only operate with
95% of crew (excluding any newly
embarking crew in quarantine) and 95%
of passengers who are fully vaccinated
may, at their discretion, transition to
operating restricted passenger voyages
with less than 95% of passengers fully
vaccinated without first conducting a
simulated voyage if the following are
met:
(1) The ship must maintain a
percentage of fully vaccinated crew that
is greater than or equal to 95%.
(2) The ship must have operated on
restricted passenger voyages under an
acknowledgement by the cruise ship
operator’s responsible officials that they
will only operate with 95% of crew
(excluding any newly embarking crew
in quarantine) and 95% of passengers
who are fully vaccinated for at least 60
days.
(3) At least 14 days prior to the
transition to voyages with less than 95%
of passengers fully vaccinated, the
cruise ship operator must submit the
following to CDC:
(i) Protocols for how dining and
entertainment venues, and recreational
activities including buffets, seated
dining, bars (including between
bartenders and patrons), theaters, other
performance venues, casinos, arcade
room, spa services, fitness classes/
gymnasiums, muster drills, and other
areas where passengers congregate will
be modified to incorporate mask use,
physical distancing, and other public
health measures as outlined in CDC
technical instructions.52
(ii) Plans for training crew on new
procedures for mask use, physical
distancing, and other public health
measures as outlined in CDC technical
instructions.
(iii) Protocols for increasing the
number of isolation and quarantine
cabins and on-board support staff (e.g.,
administrative personnel, testing
personnel, contact tracers, medical
personnel) as determined by the cruise
ship operator and as needed in the event
of an outbreak.
(iv) Procedures for how crew will
identify and distinguish between
passengers who are fully vaccinated and
passengers who are not fully vaccinated.
(v) Procedures for notifying
passengers who booked a 95%
passenger vaccinated cruise that their
cruise will no longer operate as a 95%
passenger vaccinated cruise.
(vi) The cruise ship operator must
submit photographs or videos, no later
52 COVID–19

Operations Manual for Simulated
and Restricted Voyages under the Framework for
Conditional Sailing Order ⎢ Quarantine ⎢ CDC.

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than 7 days after commencing the first
voyage with less than 95% of passengers
fully vaccinated, showing compliance
with indoor mask use and physical
distancing, such as signage in elevators,
dining table arrangements, and blocking
out seats/bar stools.
Modified Simulated Voyage
Requirements in Lieu of a Full
Simulated Voyage for Cruise Ship
Operators Repositioning to U.S. Waters
and Intending To Operate With Less
Than 95% of Passengers Fully
Vaccinated
(a) Cruise ship operators that have
been conducting passenger operations
outside of U.S. waters and intend to
operate cruise ships with less than 95%
of passengers fully vaccinated after
repositioning to U.S. waters may, at
their discretion, follow the procedures
in this paragraph for conducting a
modified simulated voyage instead of
conducting a full simulated voyage if
the following are met:
(1) The ship must maintain a
percentage of fully vaccinated crew that
is greater than or equal to 95%.
(2) The ship must have operated with
passengers outside of U.S. waters for at
least 60 days before entering U.S.
waters.
(3) The cruise ship operator must
conduct at least one simulation of
embarkation screening and testing at the
port terminal it intends to use in the
U.S.—to include the number of
passengers not fully vaccinated
expected on the first voyage—unless the
ship will be operating at the terminal
already in use by the same cruise line/
brand for passenger operations.
(4) At least 14 days prior to entering
U.S. waters, the cruise ship operator
must submit the following to CDC:
(i) Protocols for how dining and
entertainment venues, and recreational
activities, including buffets, seated
dining, bars (including between
bartenders and patrons), theaters, other
performance venues, casinos, arcade
room, spa services, fitness classes/
gymnasiums, muster drills, and other
areas where passengers congregate will
incorporate mask use, physical
distancing, and other public health
measures as outlined in technical
instructions.
(ii) Plans for training crew on
procedures for mask use, physical
distancing, and other public health
measures as outlined in CDC technical
instructions.
(iii) Protocols for increasing the
number of isolation and quarantine
cabins and on-board support staff (e.g.,
administrative personnel, testing
personnel, contact tracers, medical

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personnel) as determined by the cruise
ship operator and as needed in the event
an outbreak.
(iv) Procedures for how crew will
identify and distinguish between
passengers who are fully vaccinated and
passengers who are not fully vaccinated.
(v) Procedures for notifying
passengers who booked a 95%
vaccinated cruise that their cruise will
no longer operate as a 95% vaccinated
cruise, if applicable.
(vi) An after-action report explaining
lessons learned from sailing outside of
U.S. waters and from the simulated
embarkation screening and testing (if
such a simulation was conducted).
(vii) The cruise ship operator must
submit photographs or videos, no later
than 7 days after commencing the first
voyage with less than 95% of passengers
fully vaccinated, showing compliance
with indoor mask use and physical
distancing, such as signage in elevators,
dining table arrangements, and blocking
out seats/bar stools.
Applying for a COVID–19 Conditional
Sailing Certificate 53
(a) A cruise ship operator must submit
the following to CDC at least 5 business
days prior to the date on which the
cruise ship operator proposes to
commence restricted passenger
operations:
(1) A completed CDC registration/
application form that includes the
signatures of the cruise ship operator’s
responsible officials.
(2) The name, titles, and contact
information for the cruise ship
operator’s responsible officials.
(3) A completed statement of intent
stating the name, carrying capacity for
passengers and crew, itinerary, ports of
call, length of voyage, and expected
onboard or shoreside activities, for the
cruise ship that the cruise ship operator
intends to have certified for restricted
passenger operations.
(4) A certification statement signed by
the responsible officials acknowledging
that the cruise ship operator has
complied and remains in compliance
with CDC’s requirements for a COVID–
19 Response Plan and EDC reporting
prior to applying for a COVID–19
Conditional Sailing Certificate.
(5) A certification statement signed by
the responsible officials acknowledging
that the cruise ship operator has
adopted health and safety protocols that
meet CDC’s standards for mitigating the
risk of COVID–19 among passengers and
53 Cruise ship operators who have previously
submitted and received a COVID–19 Conditional
Sailing Certificate are not required to take any
further action under this section.

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crew onboard the cruise ship that will
be commencing restricted passenger
operations and will modify these
protocols as needed to protect the
public’s health as required by CDC
technical instructions or orders.
(6) A certification statement signed by
the responsible officials acknowledging
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.
(7) A certification statement signed by
the responsible officials acknowledging
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, or in its discretion
provisionally grant the application,
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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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, cruise ship operators
must establish mechanisms to ensure
compliance, including reporting
mechanisms to notify CDC and U.S.
Coast Guard 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.
(e) As a condition of obtaining or
retaining a COVID–19 Conditional
Sailing Certificate, cruise ship operators
must comply with the requirements of
this framework. These requirements
apply to any cruise ship operating in
U.S. waters and to cruise ships
operating outside of U.S. waters if the
cruise ship operator intends for the ship
to return to operating in U.S. waters at
any time while Order remains in effect.
Amendment or Modification of COVID–
19 Conditional Sailing Certificate
(a) A cruise ship operator may seek to
amend or modify a COVID–19
Conditional Sailing Certificate issued
under this framework by submitting
such amendment or modification to
CDC for review and a determination in
accordance with this section.
(b) CDC will review the cruise ship
operator’s request to amend or modify a
COVID–19 Conditional Sailing
Certificate and either grant or deny the
request in writing. If CDC requires
additional information to ascertain
whether the cruise ship operator’s
proposed amendment or modification
meets CDC’s standards for mitigating the
risk of COVID–19 on board cruise ships,
or if it determines the request to be
incomplete, it may hold the request in
abeyance, or in its discretion
provisionally grant the application,
pending the submission of such
additional information as required by
CDC to make such a determination.
(c) CDC may require any cruise ship
operator to amend or modify a COVID–
19 Conditional Sailing Certificate based
on public health considerations specific
to the cruise ship, cruise ship operator,
or affecting the health or safety of cruise
travel as a whole.

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(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
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.54 55
(2) 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.
(3) 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-ofcare 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.
(4) The cruise ship operator must
report syndromic surveillance and all
laboratory test results using CDC’s EDC
form as required by CDC technical
instructions or orders.
(5) The cruise ship operator must
meet standards for hand hygiene, face
masks, and physical distancing for
passengers and crew, as well as ship
sanitation, as required by CDC technical
instructions or orders.
(6) The cruise ship operator must
modify meal service and entertainment
venues to facilitate physical distancing
as required by CDC technical
instructions or orders.
(b) In light of public health
considerations and based on evidence
gained through review and evaluation of
54 COVID–19 Operations Manual for Simulated
and Restricted Voyages under the Framework for
Conditional Sailing Order ⎢ Quarantine ⎢ CDC.
55 Technical Instructions for Mitigation of
COVID–19 Among Cruise Ship Crew ⎢ Quarantine
⎢ CDC.

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cruise operators’ practices and
procedures, including through
simulated voyages, CDC may require the
following:
(1) Post-day of disembarkation
laboratory testing of passengers and
crew.
(2) 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

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(a) Based on 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 isolate any sick or
infected passengers and crew in single
occupancy cabins with private
bathrooms and quarantine all remaining
passengers and non-essential crew.
(3) 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.
(4) Arrange to disembark and
transport passengers and crew using
noncommercial transportation or other
transportation in accordance with CDC’s
technical instructions and orders.
(5) Instruct disembarking passengers
and crew to stay home and continue to
practice physical distancing after
reaching their final destination as per
CDC technical instructions or orders.
(6) Inform ship pilots, ground
transportation, aircraft 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).
(7) If the ship meets the red ship
criteria,56 immediately end the
restricted passenger voyage, cancel
future restricted passenger voyages until
56 A ship will be considered as meeting red ship
criteria if the ship has sustained transmission of
COVID–19 or CLI, or potential for COVID–19 cases
to overwhelm on board medical center resources.
CDC may adjust these criteria based on lessons
learned from simulated voyages or restricted
passenger voyages, the evolution of the pandemic,
or other factors.

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directed by CDC that such voyages may
resume, and return the ship to the U.S.
port of embarkation.
(b) CDC may issue additional
technical instructions or orders
regarding what measures cruise ship
operators must take in the event that a
threshold of COVID–19 cases is detected
in passengers or crew.
Denials, Suspension, Revocation, and
Reinstatement of a Cruise Ship
Operator’s COVID–19 Conditional
Sailing Certificate
(a) CDC may deny an application for
a COVID–19 Conditional Sailing
Certificate, or revoke, or suspend a
COVID–19 Conditional Sailing
Certificate if:
(1) The cruise ship operator is not in
compliance with CDC’s standards for
mitigating the risk of COVID–19 on
board cruise ships; or
(2) the cruise ship operator is not in
compliance with the terms of its
COVID–19 Conditional Sailing
Certificate; or
(3) necessary to protect human health
or safety based on public health
considerations specific to the particular
cruise ship operator, cruise ship, or
affecting cruise travel as a whole.
(b) CDC may reinstate a suspended or
revoked COVID–19 Conditional Sailing
Certificate after:
(1) Inspecting the cruise ship
operator’s properties and records,
including, but are not limited to, its
vessels, facilities, vehicles, equipment,
communications, manifests, list of
passengers, and employee and
passenger health records;
(2) conferring with the cruise ship
operator, responsible officials, or other
persons under the cruise ship operator’s
employ; and
(3) receiving information and written
assurances from the cruise ship operator
and/or its responsible officials that any
deficiencies have been rectified and
actions taken to ensure future
compliance.
Administrative Review
(a) A cruise ship operator may appeal
a denial of its application for a COVID–
19 Conditional Sailing Certificate or a
revocation or suspension of its COVID–
19 Conditional Sailing Certificate based
on specific factors particular to that
operator.
(b) The cruise ship operator’s appeal
must be in writing, state the factual
basis for the appeal, and be submitted
to the CDC Director within 30 calendar
days of the decision.
(c) The CDC Director’s decision will
be issued in writing and will constitute
final agency action. Prior to deciding

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59733

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, or
other persons under the cruise ship
operator’s employ.
This Order enters into effect on
November 1, 2021 at 12:01 a.m. (EDT)
upon the expiration of the current
Order. While this temporary extension
retains current requirements in place
and does not impose any new
obligations or burdens, CDC is
committed to working with cruise ship
operators who have requested a
minimum of 14 days’ advance notice to
inform their passenger clientele, adjust
itineraries as needed, and extend
existing contractual arrangements and
memorandums of understanding with
port, housing, and medical providers.
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) January 15, 2022 at 12:01 a.m. (EST).
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 25, 2021.
Sherri Berger,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2021–23573 Filed 10–26–21; 11:15 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–N–0190; FDA–
2012–N–0197; FDA–2014–N–1414; and
FDA–2014–N–0913]

Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
SUMMARY:

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