No Sail Order FRN

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estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street, Washington, DC 20405,
telephone 202–501–4755. Please cite
OMB Control No. 3090–0163,
Information Specific to a Contract or
Contracting Action (Not Required by
Regulation), in all correspondence.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2020–21982 Filed 10–2–20; 8:45 am]
BILLING CODE 6820–61–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
No Sail Order and Suspension of
Further Embarkation; Third
Modification and Extension of No Sail
Order and Other Measures Related to
Operations
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 U.S. Department of
Health and Human Services (HHS),
announces a third modification and
extension of the No Sail Order and
Other Measures Related to Operations
that was issued on July 16, 2020. This
Order applies to cruise ships defined as
commercial, non-cargo, passengercarrying vessels with the capacity to
carry 250 or more individuals
(passengers and crew) and with an
itinerary anticipating an overnight stay
onboard or a 24-hour stay onboard for
either passengers or crew, that are
operating in international, interstate, or
intrastate waterways, subject to the
jurisdiction of the United States. This
Order shall additionally apply to cruise
ships operating outside of U.S. waters if

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SUMMARY:

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the cruise ship operator intends for the
ship to return to operating in
international, interstate, or intrastate
waterways, subject to the jurisdiction of
the United States during the period that
this Order is in effect.
DATES: This action was effective
September 30, 2020.
FOR FURTHER INFORMATION CONTACT:
Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS V18–2, Atlanta,
GA 30329. Phone: 404–498–1600.
Email: [email protected].
SUPPLEMENTARY INFORMATION: This
Order renews the No Sail Order and
Other Measures Related to Operations
signed by the CDC Director on March
14, 2020, as further modified and
extended effective April 15, 2020, and
July 16, 2020 subject to the
modifications and additional stipulated
conditions as set forth in this Order.
This Order shall remain in effect until
the earliest of (1) the expiration of the
Secretary of Health and Human
Services’ declaration that COVID–19
constitutes a public health emergency;
(2) the CDC Director rescinds or
modifies the order based on specific
public health or other considerations; or
(3) October 31, 2020.
A copy of the order is provided below
and a copy of the signed order can be
found at https://www.cdc.gov/
quarantine/cruise/index.html.
U.S. Department of Health and Human
Services (HHS)
Centers for Disease Control and
Prevention (CDC)
Order Under Sections 361 & 365 of the
Public Health Service Act (42 U.S.C.
264, 268) and 42 Code of Federal
Regulations Part 70 (Interstate) and
Part 71 (Foreign):
Third Modification and Extension of No
Sail Order and Other Measures Related
to Operations
Executive Summary
The coronavirus disease 2019
(COVID–19) pandemic continues to
spread rapidly around the world with
no approved treatment or vaccine. By
July 16, 2020, the date of the second
modification and extension of the No
Sail Order, there were over 13 million
confirmed cases and over 580,000
confirmed deaths worldwide. As of
September 28, 2020, a cumulative total
of over 33 million cases and almost 1
million confirmed deaths have now
been reported worldwide. Even in
countries that have managed to slow the
rate of transmission, the risks for

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COVID–19 resurgence remains. In the
United States, as of September 28, 2020,
there have been over 7 million cases and
more than 200,000 confirmed deaths
with over 300,000 new cases reported in
the last 7 days.
Since HHS/CDC’s original No Sail
Order, signed on March 14, 2020, which
suspended the embarkation of
passengers, CDC has worked to control
the spread of the virus associated with
COVID–19 on cruise ships that
remained in U.S. jurisdiction, while
protecting against further introduction
and spread of the virus associated with
COVID–19 into U.S. communities.
Cruise ships continue to be an unsafe
environment with close quarters where
the disease spreads easily and is not
readily detected.
Cumulative CDC data from March 1
through September 28, 2020, show a
total of 3,689 confirmed cases of
COVID–19 1 or COVID-like illness 2
cases on cruise ships and 41 deaths.
These data have also revealed a total of
102 outbreaks on 124 different cruise
ships, meaning more than 82% of ships
within U.S. jurisdiction were affected by
COVID–19 during this time frame. In
addition, four cruise ships still have
ongoing or resolving COVID–19
outbreaks on board. Recent outbreaks on
cruise ships overseas continue to
demonstrate that reduced capacity alone
has not diminished transmission.
The challenges described in this
document highlight the need for further
action prior to cruise ships safely
resuming passenger operations in the
United States. CDC supports the
decision by the Cruise Line
International Association (CLIA) and its
members to voluntarily extend the
suspension of operations for passenger
cruise ship travel through October 31,
2020.3 CDC further supports the
decisions of numerous cruise ship
operators that have voluntarily canceled
scheduled voyages involving U.S. ports
beyond the date specified by CLIA,
including Cunard,4 Crystal Cruises,5
1 Confirmed COVID–19 means laboratory
confirmation for presence of SARS-CoV–2, the virus
that causes COVID–19, by polymerase chain
reaction (PCR) testing.
2 COVID-like illness means acute respiratory
illness (ARI), influenza-like illness (ILI), or
diagnosis of pneumonia.
3 Press Release, CLIA and Its Ocean-Going Cruise
Line Members Announce Third Voluntary
Suspension of U.S. Operations, https://cruising.org/
en/news-and-research/press-room/2020/august/
clia-announces-third-voluntary-suspension-of-uscruise-operations Last accessed September 30, 2020.
4 Cunard Extends Pause in Operations, https://
www.cunard.com/en-us/contact-us/press-releases
Last accessed September 30, 2020.
5 https://www.crystalcruises.com/advisory-alerts/
voyage-cancellations. Last accessed September 30,
2020.

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Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices
Holland America,6 Oceania Cruises,7
Princess Cruise Lines,8 Viking Ocean
Cruises,9 and Windstar Cruises.10
However, because not all cruise ship
operators subject to the No Sail Order
are members of CLIA or have made
similar commitments, CDC is extending
its No Sail Order to continue to protect
the public’s health by ensuring that
passenger operations do not resume
prematurely.
Previous Orders and Incorporation by
Reference
This Order renews the No Sail Order
and Other Measures Related to
Operations signed by the CDC Director
on March 14, 2020,11 as further
modified and extended effective April
15, 2020,12 and July 16, 2020 13—subject
to the modifications and additional
stipulated conditions as set forth in this
Order.
This Order shall remain in effect until
the earliest of (1) the expiration of the
Secretary of Health and Human
Services’ declaration that COVID–19
constitutes a public health emergency;
(2) the CDC Director rescinds or
modifies the Order based on specific
public health or other considerations; or
(3) October 31, 2020.
The findings and other evidence
relied upon in issuing the March 14
Order, and April 15 and July 16, 2020,
modifications and extensions, are

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6 Press

Release, Holland America Line Extends Its
Pause Of Cruise Operations To All Departures
Through Dec. 15, 2020, https://www.holland
america.com/en_US/news/2020-press-releases/
news-08112020-FurtherPauseAug11_Dec1520.html
Last accessed September 30, 2020.
7 https://www.oceaniacruises.com/coronavirusstatement. Last accessed September 30, 2020.
8 Princess Cruises Extends Pause of Select Global
Ship Operations Until December 15, https://
www.princess.com/news/notices_and_advisories/
notices/global-ship-operations-pause-december2020.html. Last accessed September 30, 2020.
9 A letter from Chairman Torstein Hagen—August
12, 2020, https://www.vikingcruises.com/oceans/
my-trip/current-sailings/index.html Last accessed
September 30, 2020.
10 Windstar Cruises Travel Advisory—August 27,
2020, https://www.windstarcruises.com/travelhealth-advisory/ Last accessed September 30, 2020.
11 No Sail Order and Suspension of Further
Embarkation. https://www.federalregister.gov/
documents/2020/03/24/2020-06166/no-sail-orderand-suspension-of-further-embarkation. Last
accessed September 29, 2020.
12 No Sail Order and Suspension of Further
Embarkation; Notice of Modification and Extension
and Other Measures Related to Operations. https://
www.federalregister.gov/documents/2020/04/15/
2020-07930/no-sail-order-and-suspension-offurther-embarkation-notice-of-modification-andextension-and-other. Last accessed September 29,
2020.
13 No Sail Order and Suspension of Further
Embarkation. https://www.federalregister.gov/
documents/2020/07/21/2020-15810/no-sail-orderand-suspension-of-further-embarkation-secondmodification-and-extension-of-no-sail. Last
accessed September 29, 2020.

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incorporated herein by reference. Any
ambiguity or conflict between the March
14 Order, and April 15 and July 16
modifications and extensions, as further
modified and extended by the current
Order, shall be resolved in favor of the
current Order.
Statement of Intent
This Order shall be interpreted and
implemented in a manner as to achieve
the following paramount objectives:
• Preserving human life;
• Preserving the health and safety of
cruise ship crew members, port
personnel, and communities;
• Preventing the further introduction,
transmission, and spread of COVID–19
into and throughout the United States;
• Preserving the public health and
other critical resources of Federal, State,
and local governments;
• Preserving hospital, healthcare, and
emergency response resources within
the United States; and
• Maintaining the safety of shipping
and harbor conditions.
Definitions
The following definitions shall apply
for the purposes of this Order:
‘‘COVID–19’’ means coronavirus
disease 2019, the disease caused by the
coronavirus SARS-CoV–2.
‘‘Itinerary’’ means a plan to engage in
operations.
‘‘Layup’’ means reducing cruise ship
operations to those levels needed to
maintain essential machinery and
equipment so that the ship may be
returned to service at some future date.
‘‘Operations,’’ ‘‘Operate,’’ and
‘‘Operating’’ in U.S. waters mean any
action by a cruise ship operator (e.g.,
shifting berths, moving to anchor,
discharging waste, making port, or
embarking or disembarking passengers
or crew) to bring or cause a cruise ship
to be brought into or transit in or
between any international, interstate, or
intrastate waterways, that are subject to
the jurisdiction of the United States, or
maintaining a ship in layup status in
waters that are subject to the
jurisdiction of the United States.
‘‘Operator’’ means the Master of the
vessel (cruise ship) and any other crew
member responsible for cruise ship
operations and navigation, as well as
any person or entity (including a
corporate entity) that authorizes or
directs the use of a cruise ship (e.g., as
owner, lessee, or otherwise). A cruise
ship operator may be either the cruise
ship captain or the cruise line to which
the cruise ship belongs, or both. The
term ‘‘Operator’’ as used in this Order
further incorporates the terms
‘‘company,’’ ‘‘designated person,’’ and

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62733

‘‘responsible person’’ as defined in 33
CFR 96.120.
Applicability
This Modification and Extension of
No Sail Order and Other Measures
Related to Operations shall apply only
to the subset of carriers 14 described
below and hereinafter referred to as
‘‘cruise ships’’:
All commercial, non-cargo,15
passenger-carrying vessels with the
capacity 16 to carry 250 17 or more
individuals (passengers and crew) and
with an itinerary anticipating an
overnight stay onboard or a twenty-four
(24) hour stay onboard for either
passengers or crew that are operating 18
in international, interstate, or intrastate
waterways that are subject to the
jurisdiction of the United States.19
This Order shall apply to cruise ships
operating outside of U.S. waters if the
cruise ship operator intends for the ship
to return to operating in international,
interstate, or intrastate waterways that
are subject to the jurisdiction of the
United States during the period that this
Order is in effect. The Order shall
additionally apply regardless of whether
the cruise ship operator has voluntarily
agreed to suspend operations.
14 Carrier is defined by 42 CFR 71.1 to mean, ‘‘a
ship, aircraft, train, road vehicle, or other means of
transport, including military.’’
15 Given the substantial risk of person-to-person
transmission of COVID–19, as opposed to
transmission via indirect contact, this Order is
currently limited to passenger, non-cargo vessels.
16 A ship’s capacity shall be determined based on
the number of persons listed in the U.S. Coast
Guard Certificate of Inspection issued in accordance
with 46 CFR 2.01–5 and that was in effect on July
16, 2020.
17 Based on substantial epidemiologic evidence
related to congregate settings and mass gatherings,
this Order suspends operation of vessels with the
capacity to carry 250 individuals or more. Evidence
shows that settings as small as nursing homes or
movie theaters can proliferate the spread of a
communicable disease. As the numbers of
passengers and crew on board a ship increase,
certain recommended mitigation efforts such as
social distancing become more difficult to
implement. In light of the demonstrated rapid
spread of COVID–19 in cruise ship settings,
application of this Order to vessels carrying 250 or
more individuals is a prudent and warranted public
health measure.
18 This Order does not apply to cruise ships that
were in layup prior to March 14, 2020 and have
continuously remained in lay-up status since that
date.
19 This Order shall not apply to vessels operated
by a U.S. Federal or State government agency. Nor
shall it apply to vessels being operated solely for
purposes of the provision of essential services, such
as the provision of medical care, emergency
response, activities related to public health and
welfare, or government services, such as food,
water, and electricity.

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Background on CDC Actions To Control
the Spread of COVID–19 on Cruise
Ships
Under the No Sail Order, as modified
and extended on April 15 and July 16,
2020, cruise ship operations were
limited, and cruise ship operators
required to submit plans to prevent,
mitigate, and respond to the spread of
COVID–19 as a condition of obtaining or
retaining controlled free pratique to
engage in cruise ship operations in any
international, interstate, or intrastate
waterways that are subject to the
jurisdiction of the United States. Cruise
ship operators were also required to
submit No Sail Order (NSO) response
plans that ensured a safe environment
for crew to work and disembark, and
that minimized the impact on U.S.
government operations or the operations
of any state or local government, or the
U.S. healthcare system.
As of April 29, 2020, seven 20 cruise
ship operators submitted NSO response
plans representing 108 cruise ships or
about 95% of cruise ships subject to the
April 15, 2020, modification and
extension. As of September 6, all five 21
cruise ship operators with ships
remaining in U.S. waters have NSO
response plans that are complete,
accurate, and acknowledged. Only 31
out of the 108 ships (29%) that were in
U.S. waters at the start of the NSO
modification and extension on April 15
remain in U.S. waters as of September
28, 2020. Pending approval of a cruise
ship operator’s NSO response plan, CDC
allowed cruise ship operators to
disembark and repatriate crew members
from cruise ships in U.S. waters if the
operator attested to complying with
requirements to disembark crew
members through noncommercial
means so as to minimize the risk to
other travelers and communities.
Through this non-commercial travel
attestation process, CDC worked with
cruise ship operators to assist in the
disembarkation and safe return home of
approximately 8,990 crew members,
including 329 U.S. citizens and
residents.
CDC published its Interim Guidance
for Mitigation of COVID–19 Among
Cruise Ship Crew During the Period of
the No Sail Order to assist cruise ship
20 These operators included Bahamas Paradise
Cruise Lines, Carnival Corporation, Disney Cruise
Lines, Norwegian Cruise Line Holdings, Royal
Caribbean Group, Virgin Voyages, and Windstar
Cruises. MSC Cruises submitted an NSO response
plan on May 7, 2020, covering three of its ships.
21 Carnival Corporation, Virgin Voyages, and
Windstar Cruises initially submitted NSO response
plans but later withdrew their ships from U.S.
waters. Accordingly, CDC has held its review of
these NSO response plans in abeyance.

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operators in preventing, detecting, and
medically managing confirmed and
suspected cases of COVID–19 and
exposures among crew members.22 CDC
also established an enhanced
surveillance process to provide a more
complete picture of COVID–19 activity
on cruise ships. Under the Interim
Guidance, CDC requires weekly
submission of the ‘‘Enhanced Data
Collection (EDC) During COVID–19
Pandemic Form.’’ 23
COVID–19 often presents as mild
illness and many cases are
asymptomatic among people of all ages.
When symptoms are present, they are
nonspecific and similar to those of
many other respiratory infections and
noninfectious conditions such as
seasonal allergies. CDC Interim
Guidance recommended that cruise
ships’ surveillance include routine viral
testing for COVID–19, including
intermittent testing of a random sample
of symptomatic and asymptomatic crew
members. Viral tests diagnose acute
infection; the U.S. Food and Drug
Administration-authorized viral tests
include those that detect SARS–CoV–2
nucleic acid (i.e., polymerase chain
reaction [PCR]) or antigen (a rapid test).
However, availability of such routine
viral testing on cruise ships remains
limited. For these reasons, CDC does not
limit its data collection to just
confirmed cases of COVID–19 but
collects data on both confirmed cases
and COVID-like illness. These data
create a more accurate picture of the
spread of COVID–19 and its effects in
the United States and provide
additional data to inform the national
public health response. As of September
28, EDC reports have shown a total of
6,088 PCR tests performed, 294 (5%) of
which were positive for COVID–19; 24
hospitalizations; two instances of
mechanical ventilation; and 15 medical
evacuations for crew on ships within
U.S. jurisdiction since April 13, 2020.
CDC established a ‘‘COVID–19 Color
Coding System’’ for ships applicable to
cruise ship operators with an
appropriate NSO response plan for crew
management. Classification of ships
under this system requires cruise
company officials to sign an
acknowledgment of the completeness
and accuracy of their NSO response
22 CDC, Interim Guidance for Mitigation of
COVID–19 Among Cruise Ship Crew During the
Period of the No Sail Order at: https://www.cdc.gov/
quarantine/cruise/management/interim-guidanceno-sail-order.html.
23 This EDC Form is used to conduct surveillance
for COVID–19 among crew who remain on board
cruise ships using cumulative reports of acute
respiratory illness (ARI), influenza-like illness (ILI),
and pneumonia, and other clinical indicators.

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plans upon completion of CDC review
of the plan. CDC additionally provides
a provisional color status for ships
belonging to cruise ship operators that
do not yet have a complete and accurate
plan. CDC assesses the status of a ship
by reviewing surveillance data from the
weekly EDC form as well as recent
embarkations or crew transfers.
Additional details regarding the colorcoding system and color coding status
for individual ships (which is updated
weekly) may be found at https://
www.cdc.gov/coronavirus/2019-ncov/
travelers/crew-disembarkationscommercial-travel.html.
Since July 16, 2020, CDC has
conducted implementation checks on 11
cruise ships operating in U.S.
jurisdiction to review compliance with
the NSO. These implementation checks
showed that cruise ship operators were
adhering to the requirements of the NSO
and their NSO response plans.
Challenges and Limitations in Testing
Crew on Cruise Ships During the NSO
While cruise ship operators have
adhered to their NSO response plans
during this time of suspended passenger
operations, challenges remain. These
challenges include the limitations of
viral test results, including the
possibility of false negative test results,
the importance of crew quarantine in
preventing disease spread, and concerns
relating to reporting of symptoms by
crew.
Two specific cases help illustrate
these challenges. In the first case,
following a cruise ship operator’s policy
to test all newly embarking crew prior
joining a ship, a crew member was
tested in his home country and found to
be PCR-negative for COVID–19 prior to
flying to the United States to board the
ship. Pursuant to CDC
recommendations, the crew member
immediately began a 14-day quarantine
in a private cabin, and other crew
members sanitized his boarding
pathway after embarkation.
Approximately 9 hours later during a
routine temperature check, the crew
member was found dead in bed.24 The
cruise line contacted the decedent’s
family who reported that the crew
member had a dry cough and itchy
throat prior to traveling despite
reporting no symptoms during the preboarding process. A postmortem
nasopharyngeal swab was collected for
PCR testing, and the result was positive
for COVID–19.
24 This case is included in CDC’s count of deaths
from COVID–19 based on the positive PCR test
result and lack of any other apparent explanation
for the cause of death.

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

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testing alone without quarantine would
not have been enough to prevent these
two infected crew members from
exposing others onboard. Despite
preboarding screening efforts, one of
these crew members was also reluctant
to report symptoms. These factors
should be considered carefully by cruise
ship operators in planning for an
eventual return to passenger operations.
Dangers of Prematurely Resuming
Passenger Operations on Cruise Ships
There have been several recent
instances of outbreaks of COVID–19
onboard cruise ships in those countries
that have allowed passenger operations
to resume, despite cruise ship operators
implementing measures to control the
disease. On the Hurtigruten cruise ship
MS Roald Amundsen, 41 crew members
and 21 passengers were confirmed to
have COVID–19 after two voyages
occurring between July 17–24 and July
25–31 in Norway.25 The ship had 209
passengers on the first voyage and 178
on the second.26 The cruise ship
operator permitted passengers to
disembark on July 31, before the
announcement of the outbreak,
potentially spreading the virus to
dozens of towns and villages along
Norway’s western coast and setting off
an effort by public health authorities to
trace and locate the nearly 400
potentially exposed passengers.27 While
the outbreak onboard the MS Roald
Amundsen is still under investigation,
Hurtigruten has revealed that its
internal review ‘‘uncovered several
deviations from procedures, for example
when it comes to quarantining foreign
crews and the internal flow of important
information.’’ 28
Cases of COVID–19 have also been
documented on other cruise ships that
have attempted to resume passenger
operations. The SeaDream Yacht Club
temporarily halted cruising onboard the
SeaDream I in July after a passenger
who had previously shown no
symptoms disembarked from the ship
25 Hurtigruten crew members and guests test
positive for COVID–19, https://
www.hurtigruten.com/practical-information/
coronavirus-update/ra31072020/. Last accessed
September 30, 2020.
26 AP News, Outbreak hits Norway cruise ship,
could spread along coast, https://apnews.com/
781a3fa3faabde06d44749bfe57139da. Last accessed
September 30, 2020.
27 Maritime Executive, Hurtigruten’s COVID–19
Fallout Continues, https://www.maritimeexecutive.com/index.php/article/fallout-continuesfrom-hurtigruten-s-covid-19-incident. Last accessed
September 30, 2020.
28 The COVID–19 situation: Update from
Hurtigruten, https://presse.hurtigruten.no/
pressreleases/the-covid-19-situation-update-fromhurtigruten-3024635. Last accessed September 30,
2020.

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and tested positive for COVID–19 upon
returning to his home country of
Denmark.29 The Tahiti-based Paul
Gauguin cruises had a passenger test
positive for COVID–19 just three days
into its first voyage with international
passengers.30 The incident required the
French Polynesia High Commission to
initiate a contact-tracing investigation to
determine who may have been exposed
to the passenger in question.31 About
148 passengers and 192 crew members
were on board the cruise ship at the
time.32 In late July, ten crew members
on board AIDA Cruises’ AIDAblu and
AIDAmar tested positive for COVID–19
after boarding in Rostok, Germany.33 In
the United States, Uncruise Adventures
canceled its remaining voyages in
Alaska after a passenger on board the
60-person 34 passenger vessel
Wilderness Adventurer tested positive
for COVID–19.35 The incident
necessitated a contact tracing
investigation by Alaska public health
authorities and the quarantine of
passengers at a hotel in Juneau and of
crew on board the ship.36
In the above examples, cruise ship
operators had health and safety
protocols to prevent the transmission
and spread of COVID–19. The protocols
adopted by the Hurtigruten included
new sanitation measures, elimination of
self-serve buffet dining, implementation
of onboard social distancing procedures,
operating at 50% capacity, a
preboarding health questionnaire, and
restricted shore excursions.37 While
investigations are still ongoing, the
statement by Hurtigruten’s CEO that the
company failed to abide by its own
29 Travel Weekly, Another small-ship line reports
a passenger with a positive Covid test, https://
www.travelweekly.com/Cruise-Travel/SeaDreamreports-passenger-with-a-positive-Covid-test. Last
accessed September 30, 2020.
30 The Maritime Executive, One Suspected
COVID–19 Case On Cruise Ship Paul Gauguin,
https://www.maritime-executive.com/article/onesuspected-covid-19-case-on-cruise-ship-paulgauguin. Last accessed September 30, 2020.
31 Id.
32 Id.
33 USA Today, Ten AIDA cruise crew members
test positive for COVID–19; ships will still sail in
August, https://www.usatoday.com/story/travel/
cruises/2020/07/28/aida-cruises-crew-memberstest-positive-covid-19/5525310002/. Last accessed
September 30, 2020.
34 This is below the capacity established by the
NSO for passenger-carrying vessels.
35 Uncruise Adventures, Press Release, https://
www.uncruise.com/about-us/media/press-releases/
covid-cruise-not-uncruise-adventures. Last accessed
September 30, 2020.
36 Id.
37 https://www.hurtigruten.com/practicalinformation/health-and-safety-on-board/. Last
accessed September 30, 2020.

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

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Adventurer subsequently tested
positive. In these examples, voyages
were cancelled, passengers and crew
quarantined or isolated, and contact
tracing investigations conducted for
those on the ship and for passengers
who had returned to their home
communities.
More Time Needed To Assess
Effectiveness of Proposed Public Health
Interventions Prior to Resuming
Passenger Operations
Cruise ship operators have taken steps
to advance their public health response
to COVID–19, improve safety, and
achieve readiness to safely resume
passenger operations. Under the cochairmanship of former Health and
Human Services Secretary Michael O.
Leavitt, two cruise lines, Royal
Caribbean Group and Norwegian Cruise
Line Holdings, assembled a ‘‘Healthy
Sail Panel’’ of subject-matter experts
from a variety of disciplines.44 The
World Travel & Tourism Council
(WTTC) and Carnival Corporation also
recently hosted a global science summit
on COVID–19 designed, ‘‘to inform
practical, adaptable and science-based
solutions for mitigating and living with
COVID–19.’’ 45 MSC Cruises further
established its own industry-led panel
with ‘‘competency to review policy
initiatives, technical innovations, or
operational measures related to COVID–
19,’’ 46 and will presumably implement
these recommendations as its passenger
operations continue to resume in the
Mediterranean with residents of
Schengen countries.47 At the moment,
however, it is too early to assess whether
these initiatives will produce a viable set
of policies and practices that will
mitigate the transmission and spread of
COVID–19 onboard cruise ships while
minimizing the potential burden and
need for public health response
activities.
To gather more information regarding
these industry-led efforts and solicit
public input, on July 20, 2020, CDC
44 https://www.rclcorporate.com/royal-caribbeangroup-and-norwegian-cruise-line-holdings-formhealthy-sail-panel/. Last accessed September 30,
2020.
45 Press Release, https://www.carnivalcorp.com/
news-releases/news-release-details/world-leadingexperts-headline-covid-19-summit-hosted-wttc. Last
accessed September 30, 2020.
46 MSC Cruise Announces Blue-Ribbon COVID
Expert Group, Engages Specialized Maritime
Classification Society to Provide Third-Party
Verification That Its Protocol Meets Established
Guidance, https://www.msccruisesusa.com/news/
blue-ribbon-covid-expert-group. Last accessed
September 30, 2020.
47 Cruise Critic News, MSC Cruises Restarts
Cruising in the Mediterranean, https://
www.cruisecritic.com/news/5533/. Last accessed
September 30, 2020.

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published a Request for Information
(RFI) in the Federal Register related to
cruise ship planning and infrastructure,
resumption of passenger operations, and
additional summary questions.48 The
document had a comment period that
ended on September 21, 2020 and
almost 13,000 comments were received.
In light of the number of submissions
and high level of public interest,
additional time is needed for CDC to
review these comments, which may be
used to inform future public health
guidance and preventive measures
relating to travel on cruise ships.
Findings and Immediate Action
The continued spread of the COVID–
19 pandemic worldwide, risk of
resurgence in countries that have
suppressed transmission, ongoing
concerns related to the restart of
cruising internationally, and need for
additional time to assess industry
measures to control potential COVID–19
onboard cruise ships with passengers
without burdening public health,
support continuing to defer resumption
of passenger operations at this time.
Accordingly, and consistent with 42
CFR 70.2, 71.31(b), and 71.32(b), the
Director of CDC (‘‘Director’’) continues
to find that cruise ship travel
exacerbates the global spread of COVID–
19, that the scope of this pandemic is
inherently and necessarily a problem
that is international and interstate in
nature, and such transmission has not
been controlled sufficiently by the
cruise ship industry or individual State
or local health authorities. As described
in the March 14, 2020, Order, cruise
ship travel markedly increases the risk
and impact of the COVID–19 disease
epidemic within the United States. If
unrestricted cruise ship passenger
operations were permitted to resume,
infected and exposed persons
disembarking cruise ships would place
federal partners (e.g., Customs and
Border Protection and the U.S. Coast
Guard), healthcare workers, port
personnel, and communities at
substantial unnecessary risk.
The Director also continues to find
evidence to support a reasonable belief
that cruise ships are or may be infected
or contaminated with a quarantinable
communicable disease.49 This
48 Request for Information Related to Cruise Ship
Planning and Infrastructure, Resumption of
Passenger Operations, and Summary Questions,
https://www.federalregister.gov/documents/2020/
07/21/2020-15812/request-for-information-relatedto-cruise-ship-planning-and-infrastructureresumption-of-passenger. Last accessed September
30, 2020.
49 COVID–19 is a communicable disease for
which quarantine is authorized under Section 361
of the Public Health Service Act (42 U.S.C. 264) and

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reasonable belief is based on
information from epidemiologic and
other data included in this document
and the information described in the
March 14, 2020, Order and the April 15
and July 16, 2020, modifications and
extensions. As a result, persons on
board or seeking to board cruise ships
may likely be or would likely become
infected with or exposed to COVID–19
by virtue of being on board at a time
when cases of COVID–19 continue to be
reported in increasingly significant
numbers globally.50 Additionally,
persons infected on cruise ships would
be likely to transmit COVID–19 to U.S.
communities by traveling interstate after
cruising.
Accordingly, under 42 CFR 70.2, the
Director determines that measures taken
by State and local health authorities
regarding COVID–19 onboard cruise
ships are inadequate to prevent the
further interstate spread of the disease.
This Order is not a rule within the
meaning of the Administrative
Procedure Act (‘‘APA’’), but rather an
emergency action taken under the
existing authority of 42 CFR 70.2,
71.31(b), and 71.32(b). In the event that
this Order qualifies as a rule under the
APA, notice and comment and a delay
in effective date are not required
because there is good cause to dispense
with prior public notice and the
opportunity to comment on this
Order.51 Considering the public health
emergency caused by COVID–19 based
on, among other things, its potential for
spread on board cruise ships, it would
be impracticable and contrary to the
public’s health, and by extension the
public’s interest, to delay the issuance
and effective date of this Order.
Similarly, if this Order qualifies as a
rule per the definition in the APA, the
Office of Information and Regulatory
Affairs has determined that it would be
a major rule, but there would not be a
delay in its effective date as the agency
has invoked the good cause provision of
the APA.
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
42 CFR 70.1, 71.1, as listed in Executive Order
13295, as amended by Executive Orders 13375 and
13674.
50 Since the March 14, 2020, Order, the number
of global cases of COVID–19 reported by the World
Health Organization (WHO) has risen from 142,534
to more than 33 million as of September 28, 2020,
with more than 1 million deaths. See Situation
Reports, WHO, https://www.who.int/emergencies/
diseases/novel-coronavirus-2019/situation-reports.
51 See 5 U.S.C. 553(b)(B), (d)(3).

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it is held invalid, shall remain valid and
in effect.
In accordance with 42 U.S.C. 264(e),
this Order shall supersede any provision
under State law (including regulations
and provisions established by political
subdivisions of States), that conflict
with an exercise of Federal authority,
including instructions by U.S. Coast
Guard or HHS/CDC personnel
permitting ships to make port or
disembark persons under stipulated
conditions, under this Order.
This Order shall be enforceable
through the provisions of 18 U.S.C.
3559, 3571; 42 U.S.C. 243, 268, 271; and
42 CFR 70.18, 71.2.
Therefore, in accordance with
Sections 361 and 365 of the Public
Health Service Act (42 U.S.C. 264, 268)
and 42 CFR 70.2, 71.31(b), 71.32(b), for
all cruise ships described above for the
period described below, it is ordered:
Measures Related To Protecting Public
Health of Communities Signed on
March 14, 2020
These measures were implemented to
provide public health authorities, in
concert with the cruise ship industry,
the necessary pause in operations to
develop and implement an appropriate
and robust plan (1) to prevent and
mitigate the further spread of COVID–19
in communities, and (2) to prevent the
spread of the disease onboard and
ensure the health of cruise ship
passenger and crew.
Accordingly, the following terms and
conditions of the No Sail Order and
Other Measures Related to Operations
signed on March 14, 2020, as modified
and extended by this order, shall remain
in effect. Consequently, it remains
ordered:
1. Cruise ship operators shall not
disembark or reembark crew members
except as directed by the USCG, in
consultation with HHS/CDC personnel
and, as appropriate, as coordinated with
Federal, State, and local authorities.
2. Cruise ship operators shall not
embark any new passengers or crew,
except as approved by USCG, or other
Federal authorities as appropriate, in
consultation with HHS/CDC personnel.
3. While in port, the cruise ship
operator shall observe health
precautions as directed by HHS/CDC
personnel.
4. The cruise ship operator shall
comply with all HHS/CDC, USCG, and
other Federal agency instructions to
follow CDC recommendations and
guidance for any public health actions
relating to passengers, crew, ship, or any
article or thing on board the ship, as
needed, including by making ships’
manifests and logs available and

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62737

collecting any specimens for COVID–19
testing.
Measures Related to Protecting Public
Health and Crew Safety Signed on April
9, 2020, and Made Effective on April 15,
2020
These measures were implemented to,
among other things, ensure a safe
environment for crew members to work
and disembark by requiring the
submission of appropriate NSO
response plans by cruise ship operators
as a condition of obtaining controlled
free pratique 52 to continue to engage in
any cruise ship operations in any
international, interstate, or intrastate
waterways that are subject to the
jurisdiction of the United States.
Accordingly, the terms and conditions
of the Modification and Extension of No
Sail Order and Other Measures Related
to Operations, intended to protect
public health and crew safety, signed on
April 9, 2020, and made effective on
April 15, 2020, as modified and
extended by this order, shall remain in
effect. Consequently, it remains ordered:
1. As a condition of obtaining
controlled free pratique to continue to
engage in any cruise ship operations in
any international, interstate, or
intrastate waterways that are subject to
the jurisdiction of the United States,
cruise ship operators shall develop,
implement, and operationalize, an
appropriate, actionable, and robust plan
to prevent, mitigate, and respond to the
spread of COVID–19 among crew
onboard cruise ships.
2. As a condition of obtaining
controlled free pratique to continue to
engage in any cruise ship operations in
any international, interstate, or
intrastate waterways that are subject to
the jurisdiction of the United States, the
cruise ship operator shall make the plan
described in paragraph 1, above,
available to HHS/CDC and USCG
personnel.
3. An appropriate plan is one that
adequately prevents, mitigates, and
responds to the spread of COVID–19
among crew onboard cruise ships and
that, at a minimum, addresses the
following elements:
a. Onboard surveillance of crew with
acute respiratory illnesses, influenzalike illnesses, pneumonia, and COVID–
19, including reporting to HHS/CDC on
a weekly basis on overall case counts,
methods of testing, and number of crew
requiring hospitalization or medical
evacuation;
52 Under 42 CFR 71.1, controlled free pratique
means permission for a carrier to enter a U.S. port,
disembark, and begin operation under certain
stipulated conditions.

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b. Reports on the number of crew
onboard the cruise ship and any
increase in the numbers of crew with
COVID–19 made to HHS/CDC and
USCG on a daily basis for as long as the
cruise ship is within waters subject to
the jurisdiction of the United States.
c. Onboard monitoring of crew
through temperature checks and
medical screening, including addressing
frequency of monitoring and screening;
d. Training of all crew on COVID–19
prevention, mitigation, and response
activities;
e. Protocols for any COVID–19 testing,
including details relating to the shoreside transport, administration, and
operationalization of laboratory work if
onboard laboratory work is not feasible;
f. Onboard isolation, quarantine, and
social distancing protocols to minimize
the risk of transmission and spread of
COVID–19;
g. Onboard medical staffing, including
number and type of staff, and
equipment in sufficient quantity to
provide a hospital level of care (e.g.,
ventilators, facemasks, personal
protective equipment) for the infected
so as to minimize the need for
hospitalization onshore;
h. An outbreak management and
response plan to provision and assist an
affected cruise ship that relies on
industry resources, e.g., mobilization of
additional cruise ships or other vessels
to act as ‘‘hospital’’ ship for the infected,
‘‘quarantine’’ ship for the exposed, and
‘‘residential’’ ship for those providing
care and treatment, including the ability
to transport individuals between ships
as needed;
i. Categorization of affected crew into
risk categories with clear stepwise
approaches for care and management of
each category;
j. A medical care plan addressing
onboard care versus evacuation to onshore hospitals for critically ill crew,
specifying how availability of beds for
critically ill at local hospitals will be
determined in advance and how the
cruise ship operator will ensure
acceptance at local medical facilities to
treat the critically ill in a manner that
limits the burden on Federal, State, and
local resources and avoids, to the
greatest extent possible, medivac
situations. If medical evacuation is
necessary arrangements for evacuation
must be made with commercial
resources (e.g., ship tender, chartered
standby vessel, chartered airlift) and
arrangements made with a designated
medical facility that has agreed to
accept such evacuees. All medical
evacuation plans must be coordinated
with the U.S. Coast Guard;

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k. Detailed logistical planning for
evacuating and repatriating both U.S.
citizens and foreign nationals to their
respective communities and home
countries via foreign government or
industry-chartered private transport and
flights, including the steps the cruise
ship operator will take to ensure those
involved in the transport are not
exposed (i.e., without the use of
commercial flights to evacuate or
repatriate individuals, whether within
or from the United States);
l. The projected logistical and
resource impact on State and local
government and public health
authorities and steps taken to minimize
the impact and engage with these
authorities; all plans must provide for
industry/cruise line management of
suspected or confirmed cases of COVID–
19 without resource burden on Federal,
State, or local governments;
m. Plan execution in all U.S.
geographical areas—all plans must be
capable of being executed anywhere in
international, interstate, or intrastate
waterways that are subject to the
jurisdiction of the United States; and
n. Cleaning and disinfection protocols
for affected cruise ships.
4. An appropriate plan shall be
designed to minimize, to the greatest
extent possible, any impact on U.S.
government operations or the operations
of any State or local government, or the
U.S. healthcare system.
5. The cruise ship operator shall
further ensure that the plan is consistent
with the most current CDC
recommendations and guidance for any
public health actions related to COVID–
19. Where appropriate, a cruise ship
operator may coordinate the
development, implementation, and
operationalization of a plan with other
cruise ship operators, including an
industry trade group.
Measures Related to Continued
Protection of Public Health and Crew
Safety Signed on July 16, 2020, as
Modified and Extended by This Order
These measures were intended to
continue to protect U.S. communities,
ensure a safe environment for crew to
work and disembark, and defer the
embarkation of passengers until there is
a clear pathway for a safe return to
passenger operations.
Accordingly, the terms and conditions
of the Second Modification and
Extension of No Sail Order and Other
Measures Related to Operations, signed
on July 16, 2020, as modified and
extended by this order, shall remain in
effect.
Consequently, it remains ordered:

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1. Cruise ship operators shall
continue to suspend passenger
operations and not embark passengers,
except as approved by HHS/CDC
personnel and USCG, in consultation
with other federal authorities as
appropriate.
2. As a condition of obtaining or
retaining controlled free pratique to
operate in any international, interstate,
or intrastate waterways that are subject
to the jurisdiction of the United States,
cruise ship operators shall continue to
follow CDC’s Interim Guidance for
Mitigation of COVID–19 Among Cruise
Ship Crew During the Period of the No
Sail Order, including reporting to HHS/
CDC through weekly submission of the
Enhanced Data Collection (EDC) form,
as may be updated. Additionally, cruise
ship operators shall report to USCG via
Advance Notice of Vessel Arrival
(ANOA), whenever in U.S. waters.
3. For cruise ship operators with ships
that have not been in U.S. waters during
the period of the No Sail Order or
voluntarily withdrew their ships, the
following conditions must be met prior
to a ship returning to U.S. waters: (1)
submission of the EDC form for 28-days
preceding expected arrival in U.S.
waters; and (2) having a complete and
accurate NSO response plan, including
having submitted to CDC a signed
Acknowledgment of No Sail Order
Response Plan Completeness and
Accuracy.
4. As a condition of obtaining or
retaining controlled free pratique to
operate in any international, interstate,
or intrastate waterways that are subject
to the jurisdiction of the United States,
cruise ship operators with appropriate
NSO response plans shall continue to
follow the COVID–19 Color Coding
System for Cruise Ships During the
Period of the No Sail Order requiring
preventive measures for crew onboard
based on the ship’s status, as
determined by HHS/CDC.
5. As a condition of obtaining or
retaining controlled free pratique to
operate in any international, interstate,
or intrastate waterways that are subject
to the jurisdiction of the United States,
cruise ship operators with appropriate
NSO response plans shall conduct viral
testing for COVID–19 for crew in such
a manner as described in the relevant
CDC guidance with reporting of results
on the EDC form.
6. As a condition of obtaining or
retaining controlled free pratique to
operate in any international, interstate,
or intrastate waterways that are subject
to the jurisdiction of the United States,
cruise ship operators must observe the
requirements of this Order, the previous
Orders, and the most current CDC

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Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices
recommendations and guidance for any
public health actions related to COVID–
19, even when outside of U.S. waters for
any ships that intend to return to U.S.
waters during the period that this Order
remains in effect.
This Order is effective upon signature
and shall remain in effect until the
earliest of (1) the expiration of the
Secretary of Health and Human
Services’ declaration that COVID–19
constitutes a public health emergency;
(2) the CDC Director rescinds or
modifies the order based on specific
public health or other considerations; or
(3) October 31, 2020.
Authority: The authority for these orders is
Sections 361 and 365 of the Public Health
Service Act (42 U.S.C. 264, 268) and 42 CFR
70.2, 71.31(b), 71.32(b).
Dated: October 1, 2020.
Nina B. Witkofsky,
Acting Chief of Staff, Centers for Disease
Control and Prevention.
[FR Doc. 2020–22030 Filed 10–1–20; 11:15 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1602]

Revocation of Authorizations of
Emergency Use of In Vitro Diagnostic
Devices for Detection of Antibodies
Against SARS-CoV–2, the Virus That
Causes Coronavirus Disease 2019
(COVID–19)
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
revocations of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Autobio
Diagnostics Co. Ltd. (‘‘Autobio’’) for the
Anti-SARS-CoV–2 Rapid Test
(‘‘Autobio’s Test’’) and to Manufacturers
and Other Stakeholders
(‘‘Stakeholders’’) for certain in vitro
diagnostic SARS-CoV–2 Antibody Tests.
FDA revoked Autobio’s Authorization
on August 6, 2020, and the
Stakeholders’ Authorization on July 21,
2020, under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The
revocations, which include an
explanation of the reasons for each
revocation, are reprinted in this
document.

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SUMMARY:

Autobio’s Authorization is
revoked as of August 6, 2020. The

DATES:

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Jkt 253001

Stakeholders’ Authorization is revoked
as of July 21, 2020.
ADDRESSES: Submit written requests for
single copies of the revocations to the
Office of Counterterrorism and
Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4338, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a Fax number to which the
revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT:
Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
240–402–8155 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. On April
24, 2020, FDA issued an EUA for
Autobio’s Anti-SARS-CoV–2 Rapid Test,
subject to the terms of the
Authorization. On April 28, 2020, FDA
issued an EUA to Stakeholders, for
certain in vitro diagnostic SARS-CoV–2
Antibody Tests (lateral flow or enzymelinked immunosorbent assay tests to
detect IgG only, IgG and IgM, or total
antibodies in human plasma and/or
serum) for use at laboratories certified
under the Clinical Laboratory
Improvement Amendments of 1988, 42
U.S.C. 263a, to perform moderate or
high complexity tests. Notice of the
issuance of the Authorizations was
published in the Federal Register on
July 14, 2020 (85 FR 42407), as required
by section 564(h)(1) of the FD&C Act.
Subsequent to the issuance of the
Authorization for Autobio’s Test, FDA
considered new information, including
from an independent evaluation of
Autobio’s Test from the National
Institute of Health’s Frederick National
Laboratory for Cancer Research, part of
the National Cancer Institute (the ‘‘NCI
study’’), demonstrating performance
below the performance information
submitted in Autobio’s original EUA
request and reflected in the authorized
labeling for Autobio’s Test. Subsequent

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to the Stakeholders’ Authorization, FDA
considered that no device had been
listed under the EUA and that FDA may
issue individual EUAs instead.
II. EUA Criteria for Issuance No Longer
Met and Other Circumstances Make
Revocation Appropriate To Protect the
Public Health or Safety
Under section 564(g)(2)(B) and (C) of
the FD&C Act, the Secretary of HHS may
revoke an EUA if, among other things,
the criteria for issuance are no longer
met or other circumstances make such
revocation appropriate to protect the
public health or safety. On August 6,
2020, FDA revoked the EUA for
Autobio’s Test because the criteria for
issuance were no longer met and other
circumstances make such revocation
appropriate to protect the public health
or safety. Under section 564(c)(2) of the
FD&C Act, an EUA may be issued only
if FDA concludes that, based on the
totality of scientific evidence available,
including data from adequate and wellcontrolled clinical trials, if available, it
is reasonable to believe that the product
may be effective in diagnosing, treating,
or preventing such disease or condition
and that the known and potential
benefits of the product, when used to
diagnose, prevent, or treat such disease
or condition, outweigh the known and
potential risks of the product.
Given the poor device performance
observed in the NCI study since the
issuance of the Authorization for
Autobio’s Test, FDA has concluded it is
not reasonable to believe the product
may be effective in detecting antibodies
against SARS-CoV–2 or that the known
and potential benefits of the device
outweigh its known and potential risks.
In addition, based on the same
information and the risks to public
health from false test results, FDA has
concluded under section 564(g)(2)(C) of
the FD&C Act that other circumstances
make revocation appropriate to protect
the public health or safety. Accordingly,
FDA has revoked EUA200349 for
Autobio’s Anti-SARS-CoV–2 Rapid Test,
pursuant to section 564(g)(2)(B) and (C)
of the FD&C Act. On July 21, 2020, FDA
revoked the EUA for Stakeholders’
certain in vitro diagnostic SARS-CoV–2
Antibody Tests because other
circumstances make such revocation
appropriate to protect the public health
or safety (section 564(g)(2)(C) of the
FD&C Act), considering that no device
has been listed under the EUA, and FDA
can issue individual EUAs instead.
III. Electronic Access
An electronic version of this
document and the full text of the
revocations are available on the internet

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