Requirement for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery From COVID-19 for All Airline or Other Aircraft Passengers Arriving Into the United States From Any Foreign Country, 61252-61276 [2021-24388]
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices
regulations at 42 CFR 71.4, 71.20, 71.31,
and 71.32.
Sherri Berger,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2021–24386 Filed 11–3–21; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Delegation of Authority
Notice is hereby given that pursuant
to Section 222 of the Public Health
Service Act [42 U.S.C. 217a], as
amended, I have delegated to the
Director, Centers for Disease Control
and Prevention (CDC), authority to
appoint temporary members to the
National Institute for Occupational
Safety and Health’s Safety and
Occupational Health Study Section
(SOHSS). This authority may be
redelegated by the CDC Director.
This delegation supersedes the June 7,
2016, delegation concerning this
authority.
This delegation became effective upon
date of signature. In addition, I affirmed
and ratified any actions taken by the
Director, CDC or her subordinates that
involved the exercise of the authorities
delegated herein, or substantially
similar authorities vested in me by prior
annual HHS appropriations acts, prior
to the effective date of the delegation.
Dated: November 2, 2021.
Xavier Becerra,
Secretary.
[FR Doc. 2021–24249 Filed 11–4–21; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
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jspears on DSK121TN23PROD with NOTICES1
Centers for Disease Control and
Prevention
Requirement for Negative PreDeparture COVID–19 Test Result or
Documentation of Recovery From
COVID–19 for All Airline or Other
Aircraft Passengers Arriving Into the
United States From Any Foreign
Country
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice of agency amended
order.
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The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces an
Amended Order requiring negative predeparture COVID–19 test results or
documentation of recovery from
COVID–19 for all airline or other aircraft
passengers arriving into the United
States from any foreign country. This
Amended Order was signed by the CDC
Director on October 25, 2021, and
supersedes the previous Order signed by
the CDC Director on January 25, 2021.
DATES: This Amended Order will
become effective at 12:01 a.m. on
November 8, 2021.
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. Telephone: 404–498–1600.
Email: dgmqpolicyoffice@cdc.gov.
SUPPLEMENTARY INFORMATION: This
Amended Order updates COVID–19
testing requirements for air passengers 2
years of age and older boarding a flight
to the United States, depending on their
COVID–19 vaccination status.
This Amended Order prohibits the
boarding of any passenger 2 years of age
and older on any airline or aircraft
destined to the United States from a
foreign country unless the passenger
presents:
(1) Paper or digital documentation of
a negative pre-departure viral test result
for SARS–CoV–2, the virus that causes
COVID–19, that meets one of the
following requirements:
• For passengers who are fully
vaccinated against COVID–19, the viral
test must be conducted on a specimen
collected no more than 3 days before the
flight’s departure from a foreign
country.
• For passengers not fully vaccinated
against COVID–19, the viral test must be
conducted on a specimen collected no
more than 1 day before the flight’s
departure from a foreign country.
Or
(2) Paper or digital documentation of
recovery from COVID–19 in the form of
both:
• A positive viral test result
conducted on a specimen collected no
more than 90 days before the flight; and
• A letter from a licensed health care
provider or public health official stating
that the passenger has been cleared for
travel.
This Amended Order also constitutes
a controlled free pratique to any airline
or other aircraft operator with an aircraft
arriving into the United States. Pursuant
to this controlled free pratique, the
SUMMARY:
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airline or other aircraft operator must
comply with the requirements outlined
in the Amended Order.
A copy of the Amended Order and
Passenger Attestation form is provided
below. A copy of the signed Amended
Order and Passenger Attestation form
can be found at https://www.cdc.gov/
quarantine/fr-proof-negative-test.html.
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
Notice and Amended Order Under
Section 361 of the Public Health Service
Act (42 U.S.C. 264) and 42 Code of
Federal Regulations 71.20 & 71.31(b)
Requirement for Negative PreDeparture COVID–19 Test Result or
Documentation of Recovery From
COVID–19 for All Airline or Other
Aircraft Passengers Arriving Into the
United States From Any Foreign
Country
Summary
Pursuant to 42 CFR 71.20, 71.31(b)
and as set forth in greater detail below,
this Notice and Amended Order 1
prohibits the boarding of any
passenger—2 years of age or older—on
any aircraft destined to the United
States 2 from a foreign country unless
the passenger 3 presents:
(1) Paper or digital documentation of
a negative pre-departure viral test result
for SARS–CoV–2, the virus that causes
COVID–19, that meets one of the
following requirements:
• For passengers who are fully
vaccinated against COVID–19, the viral
test must be conducted on a specimen
collected no more than 3 calendar days
before the flight’s departure from a
foreign country (Qualifying Test for
Fully Vaccinated).
• For passengers who are not fully
vaccinated against COVID–19, the viral
test must be conducted on a specimen
collected no more than 1 calendar day
before the flight’s departure from a
foreign country (Qualifying Test for Not
Fully Vaccinated).
Or
(2) Paper or digital documentation of
recovery from COVID–19 in the form of
both:
1 This Amended Order supersedes the previous
order signed by the Centers for Disease Control and
Prevention (CDC) Director on January 25, 2021.
2 This includes any flight, regardless of whether
the United States is final destination or connection
to another country.
3 A parent or other authorized individual may
present the required documentation on behalf of a
passenger 2–17 years of age. An authorized
individual may act on behalf of any passenger who
is unable to act on their own behalf (e.g., by reason
of age, or physical or mental impairment).
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• A positive viral test result
conducted on a specimen collected no
more than 90 calendar days before the
flight; and
• A letter from a licensed healthcare
provider or public health official stating
that the passenger has been cleared for
travel (Documentation of Recovery).
The option to present Documentation
of Recovery is available to passengers
regardless of their vaccination status.
Passengers who have a Qualifying
Test for Fully Vaccinated, i.e., a
negative pre-departure viral test
conducted on a specimen collected no
more than 3 calendar days before the
flight’s departure from a foreign
country, must have paper or digital
documentation of being fully vaccinated
with an Accepted COVID–19 Vaccine
(Proof of Being Fully Vaccinated
Against COVID–19).
Passengers who have a Qualifying
Test for Not Fully Vaccinated, i.e., a
negative pre-departure viral test
conducted on a specimen collected no
more than 1 calendar day before the
flight’s departure from a foreign
country, do not need to present Proof of
Being Fully Vaccinated Against COVID–
19.
Alternatively, if a passenger has tested
positive for SARS–CoV–2 on a specimen
collected no more than 90 calendar days
before the flight’s departure and
recovered from COVID–19 (i.e., met
CDC criteria to end isolation),4 the
passenger may instead travel with paper
or digital documentation of the positive
viral test result that confirms the
previous SARS–CoV–2 infection and a
letter from a licensed healthcare
provider or public health official stating
that the passenger has been cleared for
travel (Documentation of Recovery).
Each passenger must retain paper or
digital documentation presented to the
airline or other aircraft operator
reflecting one of the following:
• Negative result for Qualifying Test
for Fully Vaccinated plus Proof of Being
Fully Vaccinated Against COVID–19;
• Negative result for the Qualifying
Test for Not Fully Vaccinated; or
• Documentation of Recovery from
COVID–19.
A passenger, or the passenger’s
authorized representative, must also
produce such documentation upon
request to any U.S. government official
or a cooperating state or local public
health authority.
Pursuant to 42 CFR 71.31(b) and as set
forth in greater detail below, this Notice
and Amended Order constitute a
controlled free pratique to any airline or
4 https://www.cdc.gov/coronavirus/2019-ncov/
your-health/quarantine-isolation.html.
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other aircraft operator with an aircraft
arriving in the United States.5 Pursuant
to this controlled free pratique, the
airline or other aircraft operator must
comply with the following conditions to
receive permission for the aircraft to
enter and disembark passengers in the
United States:
• Airline or other aircraft operator
must confirm that every passenger
onboard the aircraft based on
vaccination status has documentation of
a negative result for a Qualifying Test
for Fully Vaccinated plus Proof of Being
Fully Vaccinated Against COVID–19, a
negative result for a Qualifying Test for
Not Fully Vaccinated, or Documentation
of Recovery.
• Airline or other aircraft operator
must verify that every passenger
onboard the aircraft based on
vaccination status has attested to
receiving a negative result for the
Qualifying Test for Fully Vaccinated
plus being fully vaccinated, receiving a
negative result for the Qualifying Test
for Not Fully Vaccinated, or having
tested positive for SARS–CoV–2 on a
specimen collected no more than 90
calendar days before the flight and been
cleared to travel as Documentation of
Recovery.6
Statement of Intent
This Order shall be interpreted and
implemented to achieve the following
paramount objectives:
• Preservation of human life;
• Preventing the further introduction,
transmission, and spread of the virus
that causes COVID–19 into the United
States, including new virus variants;
• Preserving the health and safety of
crew members, passengers, airport
personnel, and communities; and
• Preserving hospital, healthcare, and
emergency response resources within
the United States.
Definitions
Accepted COVID–19 Vaccine means:
5 On October 25, 2021, the President issued a
Proclamation pursuant to Sections1182(f) and
1185(a)(1) of Title 8, and Section 301 of Title 3,
United States Code, titled, ‘‘Advancing the Safe
Resumption of Global Travel During the COVID–19
Pandemic.’’ Pursuant to this Proclamation. The
President has implemented a global suspension and
restriction on entry for noncitizens who are
nonimmigrants seeking to enter the United States
by air travel and who are not fully vaccinated
against COVID–19. This amended CDC Order
complements and advances the safe resumption of
global travel.
6 A parent or other authorized individual may
present the required documentation on behalf of a
passenger 2–17 years of age. An authorized
individual may act on behalf of any passenger who
is unable to act on their own behalf (e.g., by reason
of age, or physical or mental impairment).
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• A vaccine authorized for emergency
use or approved by the U.S. Food and
Drug Administration; 7 or
• A vaccine listed for emergency use
by the World Health Organization
(WHO); 8 or
• A vaccine or combination of
vaccines 9 listed by CDC in CDC’s
Technical Instructions for Implementing
Presidential Proclamation Advancing
Safe Resumption of Global Travel
During the COVID–19 Pandemic and
CDC’s Order.
Aircraft shall have the same definition
as under 49 U.S.C. 40102(a)(6).
‘‘Aircraft’’ includes, but is not limited
to, commercial, general aviation, and
private aircraft destined for the United
States from a foreign country.
Aircraft Operator means an individual
or organization causing or authorizing
the operation of an aircraft.
Airline shall have the same definition
as under 42 CFR 71.1(b).
Attest/Attestation means having
completed the attestation in Attachment
A.10 Such attestation may be completed
in paper or digital form. The attestation
is a statement, writing, entry, or other
representation under 18 U.S.C. 1001.11
Documentation of Recovery means
paper or digital documentation of
recovery from COVID–19 in the form of
a positive SARS–CoV–2 viral test result
7 For a list of vaccines approved or authorized in
the United States to prevent COVID–19, see https://
www.cdc.gov/coronavirus/2019-ncov/vaccines/
different-vaccines.html.
8 See WHO’s website for more information about
WHO emergency use-listed COVID–19 vaccines.
9 CDC has not recommended the use of
heterologous (i.e., mix-and-match) primary series.
However, the use of such strategies (including
mixing of mRNA, adenoviral, and mRNA plus
adenoviral products) is increasingly common in
many countries outside of the United States.
Accordingly, additional vaccinations or
combinations of vaccinations may be listed in
CDC’s in Technical Instructions for Implementing
Presidential Proclamation Advancing Safe
Resumption of Global Travel During the COVID–19
Pandemic and CDC’s Order for purposes of the
interpretation of vaccination records.
10 CDC has provided a combined passenger
disclosure and attestation that fulfills the
requirements of CDC Orders: Requirement for Proof
of Negative COVID–19 Test Result or Recovery from
COVID–19 for All Airline Passengers Arriving into
the United States and Order Implementing
Presidential Proclamation on Advancing the Safe
Resumption of Global Travel During the COVID–19
Pandemic.
11 CDC encourages airlines and aircraft operators
to incorporate the attestation into paperless checkin processes. An airline or aircraft operator may use
a third party (including a third-party application) to
collect attestations, including to provide
translations. However, an airline or aircraft operator
has sole legal responsibility to provide and collect
attestations, to ensure the accuracy of any
translation, and to comply with all other obligations
under this Order. An airline or aircraft operator is
responsible for any failure of a third party to
comply with this Order. An airline or aircraft
operator may not shift any legal responsibility to a
third party.
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and a letter from a licensed healthcare
provider or public health official stating
that the person has been cleared for
travel (i.e., has recovered).12 13 The viral
test must have been conducted on a
specimen collected no more than 90
calendar days before the departure of
the flight.
Foreign country means anywhere that
is not a state, territory, or possession of
the United States.
Fully Vaccinated Against COVID–19
means it has been:
• 2 weeks (14 days) or more since a
person received one dose of an accepted
single-dose series COVID–19 vaccine;
OR
• 2 weeks (14 days) or more since a
person’s second dose in a 2-dose series
of an accepted COVID–19 vaccine; OR
• 2 weeks (14 days) or more since a
person received a complete series of a
vaccine or combination of vaccines
listed by CDC in CDC’s Technical
Instructions for Implementing
Presidential Proclamation Advancing
Safe Resumption of Global Travel
During the COVID–19 Pandemic and
CDC’s Order.
Not Fully Vaccinated Against COVID–
19 means a person does not meet the
definition of Fully Vaccinated Against
COVID–19.
Proof of Being Fully Vaccinated
against COVID–19 means a person has
an acceptable paper or digital format of
a vaccination record or a verifiable
vaccination record confirming that the
person is Fully Vaccinated Against
COVID–19 as defined and listed by CDC
in CDC’s Technical Instructions for
Implementing Presidential Proclamation
Advancing Safe Resumption of Global
Travel During the COVID–19 Pandemic
and CDC’s Order.
Qualifying Test for Fully Vaccinated
means a negative result on a SARS–
CoV–2 viral test that was conducted on
a specimen collected no more than 3
calendar days before the flight’s
departure from a foreign country to the
United States for passengers who have
Proof of Being Fully Vaccinated Against
COVID–19.
Qualifying Test for Not Fully
Vaccinated means a negative result on
a SARS–CoV–2 viral test that was
conducted on a specimen collected no
more than 1 calendar day before the
12 Healthcare providers and public health officials
should follow CDC guidance in clearing patients for
travel to the United States. Applicable guidance is
available at https://www.cdc.gov/coronavirus/2019ncov/hcp/disposition-in-home-patients.html.
13 A letter from a healthcare provider or a public
health official that clears the person to end isolation
(e.g., to return to work or school), can also be used
to show that the person has been cleared to travel,
even if travel is not specifically mentioned in the
letter.
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flight’s departure from a foreign country
to the United States for passengers who
do not have Proof of Being Fully
Vaccinated Against COVID–19.
United States has the same definition
as ‘‘United States’’ in 42 CFR 71.1(b),
meaning ‘‘the 50 States, District of
Columbia, and the territories (also
known as possessions) of the United
States, including American Samoa,
Guam, the Northern Mariana Islands,
the Commonwealth of Puerto Rico, and
the U.S. Virgin Islands.’’
Viral test means a viral detection test
for current infection (i.e., a nucleic acid
amplification test [NAAT] or a viral
antigen test) approved or authorized by
the relevant national authority or the
U.S. Food and Drug Administration for
the detection of SARS–CoV–2.
U.S. Department of Defense guidance to
prevent the transmission of COVID–19
as set forth in Force Protection
Guidance Supplement 20—Department
of Defense Guidance for Personnel
Traveling During the Coronavirus
Disease 2019 Pandemic (April 12, 2021)
including its testing guidance.16
• Individuals and organizations for
which the issuance of a humanitarian
exemption is necessary based on both:
(1) Exigent circumstances where
emergency travel is required to preserve
health and safety (e.g., emergency
medical evacuations) and (2) where predeparture testing cannot be accessed or
completed before travel because of
exigent circumstances. Additional
conditions may be placed on those
granted such exemptions, including but
not limited to, observing precautions
during travel, providing consent to postarrival testing, and/or self-quarantine
after arrival in the United States, as may
be directed by federal, state, territorial,
tribal or local public health authorities
to reduce the risk of transmission.
Exemptions
The following categories of
individuals and organizations are
exempt from the requirements of this
Amended Order:
• Crew members of airlines or other
aircraft operators if they follow industry
standard protocols for the prevention of
COVID–19 as set forth in relevant Safety
Alerts for Operators (SAFOs) issued by
the Federal Aviation Administration
(FAA).14
• Airlines or other aircraft operators
transporting passengers with COVID–19
pursuant to CDC authorization and in
accordance with CDC guidance.15
• U.S. federal law enforcement
personnel on official orders who are
traveling for the purpose of carrying out
a law enforcement function, provided
they are covered under an occupational
health and safety program that takes
measures to ensure personnel are not
symptomatic or otherwise at increased
risk of spreading COVID–19 during
travel. Those traveling for training or
other business purposes remain subject
to the requirements of this Order.
• U.S. military personnel, including
civilian employees, dependents,
contractors, and other U.S. government
employees when traveling on U.S.
military assets (including whole aircraft
charter operators), if such individuals
are under competent military or U.S
government travel orders and observing
Since January 2020, the respiratory
disease known as ‘‘COVID–19,’’ caused
by a novel coronavirus (SARS–CoV–2),
has spread globally, including cases
reported in all 50 states within the
United States, plus the District of
Columbia and all U.S. territories. As of
October 22, 2021, there have been over
242,000,000 million cases of COVID–19
globally, resulting in over
4,900,000deaths.17 More than
45,000,000 cases have been identified in
the United States, with new cases
reported daily, and over 733,000 deaths
have been attributed to the disease. A
renewed surge in cases in the United
States began in early July 2021; daily
case counts rose from 19,000 cases on
July 1, 2021 to 159,000 cases on
September 1, 2021. While cases are
currently decreasing in the United
States, during the entirety of this
pandemic, cases have tended to surge in
waves, including after high-volume
travel periods, with 4 waves as of
October 2021.18 Therefore, additional
14 Airlines, aircraft operators, and their crew
members may follow stricter protocols for crew and
passenger health, including testing protocols. SAFO
20009, COVID–19: Updated Interim Occupational
Health and Safety Guidance for Air Carriers and
Crews, available at https://www.faa.gov/other_visit/
aviation_industry/airline_operators/airline_safety/
safo/all_safos/media/2020/SAFO20009.pdf.
15 Interim Guidance for Transporting or Arranging
Transportation by Air into, from, or within the
United States of People with COVID–19 or COVID–
19 Exposure, available at https://www.cdc.gov/
quarantine/interim-guidance-transporting.html.
16 Force Protection Guidance Supplement 20—
Department of Defense Guidance for Personnel
Traveling During the Coronavirus Disease 2019
Pandemic, available at https://media.defense.gov/
2021/Apr/16/2002622876/-1/-1/1/MEMORANDUMFOR-FORCE-HEALTH-PROTECTION-GUIDANCESUPPLEMENT%2020-DEPARTMENT-OFDEFENSE-GUIDANCE-FOR-PERSONNELTRAVELING-DURING-THE-CORONAVIRUSDISEASE-2019-PANDEMIC.PDF.
17 https://covid19.who.int/.
18 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
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Background
A. COVID–19 Pandemic
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surges of cases and deaths are very
possible.
Many countries have begun
widespread vaccine administration;
however, 98 countries continue to
experience high or substantial incidence
rates (>50 cases per 100,000 people in
the last seven days) and 65 countries,
including the United States, are
experiencing a high incidence of
reported new cases at this time.19
SARS–CoV–2 spreads mainly from
person-to-person through respiratory
fluids released during exhalation, such
as when an infected person coughs,
sneezes, or talks.
Exposure to these respiratory fluids
occurs in three principal ways: (1)
Inhalation of very fine respiratory
droplets and aerosol particles, (2)
deposition of respiratory droplets and
particles on exposed mucous
membranes in the mouth, nose, or eye
by direct splashes and sprays, and (3)
touching mucous membranes with
hands that have been soiled either
directly by virus-containing respiratory
fluids or indirectly by touching surfaces
with virus on them.20 21 Spread is more
likely when people are in close contact
with one another (within about 6 feet),
especially in crowded or poorly
ventilated indoor settings. Persons who
are not fully vaccinated, including those
with asymptomatic or pre-symptomatic
infections, are significant contributors to
community SARS–CoV–2 transmission
and occurrence of COVID–19.22 23
Among adults, the risk for severe
illness from COVID–19 increases with
age, with older adults at highest risk.24
Severe illness means that persons with
COVID–19 may require hospitalization,
intensive care, or a ventilator to help
them breathe, and may die. People of
any age with certain underlying medical
conditions (e.g., cancer, obesity, serious
jspears on DSK121TN23PROD with NOTICES1
20 Scientific Brief: SARS–CoV–2 Transmission,
Centers for Disease Control and Prevention (May 7,
2021), https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/sars-cov-2-transmission.html.
21 Science Brief: SARS–CoV–2 and Surface
(Fomite) Transmission for Indoor Community
Environments, Centers for Disease Control and
Prevention (Apr. 5, 2021), https://www.cdc.gov/
coronavirus/2019-ncov/more/science-and-research/
surface-transmission.html.
22 Moghadas SM, Fitzpatrick MC, Sah P, et al. The
implications of silent transmission for the control
of COVID–19 outbreaks. Proc Natl Acad Sci U S A.
2020;117(30):17513–17515.10.1073/
pnas.2008373117, available at https://
www.ncbi.nlm.nih.gov/pubmed/32632012.
23 Johansson MA, Quandelacy TM, Kada S, et al.
SARS–CoV–2 Transmission from People Without
COVID–19 Symptoms. Johansson MA, et al. JAMA
Netw Open. 2021 January4;4(1):e2035057. doi:
10.1001/jamanetworkopen.2020.35057.
24 CDC. COVID–19 Risks and Vaccine Information
for Older Adults https://www.cdc.gov/aging/
covid19/covid19-older-adults.html.
21:40 Nov 04, 2021
B. Emergence of Variants of Concern
New variants of SARS–CoV–2 have
emerged globally, several of which have
been identified as variants of concern,
including the Delta variant. Some
variants are more transmissible and
some may cause more severe disease,
which can lead to more hospitalizations,
and deaths among infected
individuals.26 Furthermore, findings
suggest some variants may reduce levels
of virus neutralization by antibodies
generated during previous infection or
vaccination, resulting in reduced
effectiveness of treatments or vaccines,
or increased diagnostic detection
failures.27 The emergence of variants
that substantially decreases the
effectiveness of available vaccines
against severe or deadly disease is a
primary public health concern. 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 remains not only a
possibility, but a current reality.
As the virus spreads, it has new
opportunities to change (mutate) and
may become more difficult to control.
While it is known and expected that
viruses change through mutation
leading to the emergence of new
variants, the existing Delta variant is
particularly concerning because it
spreads more easily than previous
variants of SARS–CoV–2.28 The Delta
variant has rapidly become the
predominant strain in the United States
with more than 99% of U.S. cases
attributed to it as of October 16, 2021.29
Globally, 193 countries have reported
25 People
19 https://covid19.who.int/.
VerDate Sep<11>2014
heart conditions, diabetes, conditions
that weaken the immune system) are at
increased risk for severe illness from
COVID–19.25
Jkt 256001
with Certain Medical Conditions
https://www.cdc.gov/coronavirus/2019-ncov/needextra-precautions/people-with-medicalconditions.html.
26 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:
https://dx.doi.org/10.15585/mmwr.mm7028e2
(describing a B.1.617.2 (Delta) Variant COVID–19
outbreak associated with a gymnastics facility and
finding that the Delta variant is highly transmissible
in indoor sports settings and households, which
might lead to increased incidence rates).
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.
28 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.
29 https://covid.cdc.gov/covid-data-tracker/
#variant-proportions.
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cases of the Delta variant as of October
19, 2021.30
Of critical significance for this
Amended Order, the Delta variant has
increased transmissibility, especially
among persons who are not fully
vaccinated, and increases the risk of
infection in fully vaccinated individuals
in the absence of other mitigation
strategies, such as mask wearing.31 For
persons not fully vaccinated, Delta is a
formidable threat and the surge in cases
since the summer of 2021 has been
fueled in part by low vaccination
coverage in many U.S. communities.32
Available evidence suggests all three
vaccines currently approved or
authorized in the United States provide
significant protection.33 However, a
small proportion of people who are fully
vaccinated may become infected, a risk
that is increased with the Delta variant;
emerging evidence suggests that fully
vaccinated persons who do become
infected with the Delta variant are at
risk for transmitting it to others.34
However, the vast majority of fully
vaccinated individuals continue to be
protected from severe illness,
hospitalization, and death, even with
the Delta variant.
C. Availability of Testing and Vaccines
in the United States and Globally
The potential for asymptomatic and
pre-symptomatic transmission makes
testing an essential part of COVID–19
mitigation protocols. With the
additional testing capacity available
through antigen tests, infected persons
can be identified more rapidly so they
can be isolated until they no longer pose
a risk of spreading the virus and their
30 https://www.who.int/publications/m/item/
weekly-epidemiological-update-on-covid-19---19october-2021.
31 Delta Variant: What We Know About the
Science, https://www.cdc.gov/coronavirus/2019ncov/variants/delta-variant.html.
32 COVID Data Tracker Weekly Review,
Interpretive Summary for July 23, 2021, Centers for
Disease Control and Prevention, https://
www.cdc.gov/coronavirus/2019-ncov/covid-data/
covidview/past-reports/07232021.html https://
www.cdc.gov/coronavirus/2019-ncov/covid-data/
covidview/past-reports/07232021.html.
33 Science Brief: COVID–19 Vaccines and
Vaccination, Centers for Disease Control and
Prevention, https://www.cdc.gov/coronavirus/2019ncov/science/science-briefs/fully-vaccinatedpeople.html. Other vaccines, particularly the one
manufactured by AstraZeneca, show reduced
efficacy against infection with certain variants but
may still protect against severe disease; at the time
of the issuance of this Order, the FDA has not
authorized the AstraZeneca COVID–19 vaccine for
use in the United States.
34 Delta Variant: What We Know About the
Science, https://www.cdc.gov/coronavirus/2019ncov/variants/delta-variant.html.
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close contacts can be identified and
quarantined.35
COVID–19 vaccines are now widely
available in the United States, and
vaccination is recommended for all
people 12 years of age and older. As of
October 23, 2021, approximately 190.4
million people in the United States
(67.1% of the population 12 years or
older) have been fully vaccinated and
over 219 million people in the United
States (77.6% of the population 12 years
or older) have received at least one
dose.36 However, after a rapid increase
in the proportion of the U.S. population
vaccinated against COVID–19 in the first
months of 2021, vaccinations
administered in the United States have
slowed, particularly in those under the
age of 65 years.37
The combination of the substantial
proportion of the population that
remains not fully vaccinated either
through ineligibility (in the case of
children under 12 years) or by choice,
and the extreme transmissibility of the
Delta variant resulted in sharp increases
in COVID–19 cases in the United States
over the summer and early fall of 2021,
primarily and disproportionately
affecting persons not fully vaccinated.
The availability of COVID–19
vaccines is also rising globally but is
still small when compared to the
availability of vaccines in the United
States and a handful of other
countries.38 Approximately 6.84 billion
doses of COVID–19 vaccine have been
administered globally. However,
vaccine supplies and testing capacity
remain limited in many low-income
countries.39 40 Outbreaks linked to
international travel caused by
unvaccinated and untested travelers
have the potential to increase the
introduction, transmission, and spread
of COVID–19 variants into the United
States. Many other countries around the
35 See COVID–19 Testing and Diagnostics
Working Group (TDWG). U.S. Department of Health
and Human Services (HHS), https://www.hhs.gov/
coronavirus/testing/testing-diagnostics-workinggroup/. (defining the role of the COVID–
19 TDWG, which develops testing-related guidance
and provides targeted investments to expand the
available testing supply and maximize testing
capacity).
36 https://covid.cdc.gov/covid-data-tracker/
#vaccinations_vacc-total-admin-rate-total.
37 Ibid.
38 See ‘‘PAHO Director calls for fair and broad
access to COVID–19 vaccines for Latin America and
the Caribbean,’’ Pan American Health Organization,
https://www.paho.org/en/news/7-7-2021-pahodirector-calls-fair-and-broad-access-covid-19vaccines-latin-america-and (noting the
discrepancies in vaccine availability coverage
among North, Central, and South American
countries).
39 https://ourworldindata.org/covid-vaccinations.
40 https://ourworldindata.org/coronavirustesting#testing-vs-gdp-per-capita.
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world are making efforts to increase
COVID–19 vaccination for their
populations, with some considering or
adding proof of vaccination
requirements as a condition for
entry.41 42 43
CDC is aware of a rising number of
SARS–CoV–2 infections in vaccinated
individuals; 44 since vaccines are not
100% effective at preventing infection,
some people who are fully vaccinated
may still get COVID–19. While the
vaccines currently approved or
authorized by the FDA are successful in
preventing severe illness and death,
including from the highly transmissible
Delta variant, infections and even mild
to moderate illness have been
documented in a small percentage of
vaccinated persons. However, studies so
far show that vaccinated people are 5
times less likely to be infected and more
than 10 times less likely to experience
hospitalization or death due to COVID–
19 than people who are not fully
vaccinated.45 The emergence of the
more transmissible Delta variant, as well
as the potential emergence of a variant
of high consequence that could reduce
the effectiveness of treatments or
vaccines, increases the urgency to
expand vaccination coverage.
D. Justification for Continued PreDeparture Testing
On December 25, 2020, in response to
a new COVID–19 variant (now referred
to as the Alpha variant 46) spreading in
the United Kingdom (UK), CDC issued
an Order requiring proof of a negative
viral test result for all air passengers 2
years of age and older arriving from the
UK to the United States. A month later,
cases, including those from the Alpha
variant, continued to increase
significantly, and variants of concern
41 See CNN Travel, New Zealand says foreign
nationals must have coronavirus vaccination to
enter country from November, https://
www.cnn.com/travel/article/new-zealand-travelvaccination-covid-lockdown-ardern-intl/.
42 See CNN Canada issues COVID–19 vaccine
mandate for travelers 12 or older on trains and
planes, https://www.cnn.com/travel/article/canadatrudeau-vaccine-mandate/.
43 https://www.forbes.com/sites/geoffwhitmore/
2021/10/20/covid-19-vaccine-mandates-for-travel/
?sh=23fc0cdd4edb.
44 COVID–19 Vaccine Breakthrough Case
Investigation and Reporting, https://www.cdc.gov/
vaccines/covid-19/health-departments/
breakthrough-cases.html.
45 Scobie HM, Johnson AG, Suthar AB, et al.
Monitoring Incidence of COVID–19 Cases,
Hospitalizations, and Deaths, by Vaccination
Status—13 U.S. Jurisdictions, April 4–July 17, 2021.
MMWR Morb Mortal Wkly Rep. 2021;70(37):1284–
1290. Published 2021 Sep 17. doi:10.15585/
mmwr.mm7037e1.
46 SARS–CoV–2 Variant Classifications and
Definitions, https://www.cdc.gov/coronavirus/2019ncov/variants/variant-info.html.
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were identified in other countries,
leading to CDC issuing an Order on
January 25, 2021 requiring all air
passengers 2 years of age and older
traveling from any foreign country to
show a negative pre-departure COVID–
19 test result or documentation of
recovery from COVID–19 in the
previous 90 calendar days before
boarding a flight to the United States.
Testing for SARS–CoV–2 infection is
a proactive, risk-based approach that is
not dependent on the infecting variant.
This risk-based testing approach has
been addressed in CDC guidance and
the Runway to Recovery guidance
jointly issued by the Departments of
Transportation, Homeland Security, and
Health and Human Services.47 Most
countries now use testing in some form
to monitor risk and control introduction
and spread of SARS–CoV–2.48 With case
counts and deaths due to COVID–19,
particularly the Delta variant,
continuing to increase around the globe,
the high proportion of unvaccinated
people in the United States and around
the world, and infected people with
asymptomatic or pre-symptomatic
infections, the United States is taking a
multi-layered approach to combatting
COVID–19, concurrently preventing and
slowing the continued introduction of
cases and further spread of the virus
within U.S. communities. Vaccination is
the most important measure for
reducing risk for SARS–CoV–2
transmission during travel and in
avoiding severe illness, hospitalization,
and death; however, infections in fully
vaccinated people indicate that
vaccination is a necessary but not
sufficient measure; testing of these
travelers is still necessary and thus
required.
Pre-departure testing does not
eliminate all risk. However, when predeparture testing is combined with
other measures such as self-monitoring
for symptoms of COVID–19, wearing
masks, physical distancing, and hand
hygiene, it can make travel safer by
reducing spread on conveyances, in
transportation hubs, and at destinations.
CDC recommends all international
travelers get a viral test 3–5 days after
arrival at their U.S. destination,
combined with self-monitoring.
Additionally, CDC recommends
international travelers who are not fully
vaccinated stay home (or in a
comparable location such as a hotel
room) and self-quarantine for a full 7
47 Runway to Recovery 1.1, December 21, 2020,
available at https://www.transportation.gov/
briefing-room/runway-recovery-11.
48 https://ourworldindata.org/coronavirustesting#testing-and-contact-tracing-policy.
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days after travel, or for 10 days if they
do not get tested, to further reduce the
risk of translocating the virus into
destination communities.49
People who have recovered from
COVID–19 can continue to shed
detectable but non-infectious SARS–
CoV–2 RNA in upper respiratory
specimens for up to 3 months after
illness onset.50 For this reason, CDC
does not recommend retesting of
persons previously diagnosed with
COVID–19 within 3 months after the
date of symptom onset (or the date of
first positive viral diagnostic test if their
infection was asymptomatic) for the
initial SARS–CoV–2 infection, unless
they have symptoms of COVID–19.
People who develop any symptoms of
COVID–19 during this 90-day period
following infection should not travel
and should consult a healthcare
provider who can evaluate for other
causes of their symptoms and determine
if testing is needed. This guidance may
be updated as additional information
about people who have recovered from
COVID–19 becomes available.
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E. Pre-Departure Testing Requirements
Based on Vaccination Status
Recent CDC modeling that
incorporated the transmission
characteristics of the Delta variant
shows evidence that for persons not
fully vaccinated, getting a viral test one
day prior to departure can reduce the
risk of traveling with COVID–19 by
40%.51 When this window is expanded
to two days prior to departure, the
reduction in risk is 26%, and for three
days prior to departure, the risk
reduction is only an estimated 14%.
This modeling was based on real-world
data on virus transmissibility.52 53 54
CDC’s modeling also demonstrates
that among travelers who are fully
vaccinated with a vaccine that has 60%
effectiveness against SARS–CoV–2
infection, getting tested with a NAAT or
49 International Travel During COVID–19 https://
www.cdc.gov/coronavirus/2019-ncov/travelers/
international-travel-during-covid19.html.
50 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/duration-isolation.html.
51 Public Health Guidance for Potential COVID–
19 Exposure Associated with Travel https://
www.cdc.gov/coronavirus/2019-ncov/php/riskassessment.html.
52 He, X., Lau, E.H.Y., Wu, P. et al. Temporal
dynamics in viral shedding and transmissibility of
COVID–19. Nat Med 26, 672–675 (2020). https://
doi.org/10.1038/s41591-020-0869-5.
53 Wo
¨ lfel, R., Corman, V.M., Guggemos, W. et al.
Virological assessment of hospitalized patients with
COVID–2019. Nature 581, 465–469 (2020). https://
doi.org/10.1038/s41586-020-2196-x.
54 Rachael Pung, Tze Minn Mak, Adam J
Kucharski, Vernon J Lee, Serial intervals in SARS–
CoV–2 B.1.617.2 variant cases, The Lancet, 2021
ISSN 0140–6736, https://doi.org/10.1016/S01406736(21)01697-4.
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antigen test 3 days before departure can
reduce risk that a person is infectious
with COVID–19 during travel by 66%.55
Among fully vaccinated travelers, if this
testing window is decreased to two
days, this risk is reduced by 71%, and
by 76% at one day before travel.
Therefore, there is little public health
advantage to shortening the time period
for testing for fully vaccinated air
passengers.56 The combination of
vaccination and pre-travel testing
provides a greater level of protection
than either measure alone and is
consistent with a layered strategy.
These models informed by analyses of
real-world surveillance data support the
requirement of this Amended Order that
passengers who are not fully vaccinated
get a specimen collected for a viral
COVID–19 test no more than 1 day
before departure to the United States to
minimize the risk of transmission
during travel and importing additional
COVID–19 cases and possible variants
into the United States. The time
window between testing and travel is
particularly relevant for those with
longer-duration travel, such as traveling
long distances or on connecting flights.
However, decreasing the time window
for testing before departure from three
days to one day provides minimal
additional public health benefit for fully
vaccinated travelers. Therefore, fully
vaccinated air passengers will continue
to be allowed to get a specimen
collected no more than 3 calendar days
before their flight departure to meet the
requirements of this Amended Order.
F. Proof of Being Fully Vaccinated
Against COVID–19
Documentation of COVID–19
vaccination status varies globally.
Governments, private industries, or
medical providers may use a paper or
digital certification reflecting a person’s
COVID–19 vaccination status that
includes handwritten or typed text from
an authorized healthcare care provider,
55 Public Health Guidance for Potential COVID–
19 Exposure Associated with Travel https://
www.cdc.gov/coronavirus/2019-ncov/php/riskassessment.html.
56 CDC recommends that fully vaccinated cruise
ship passengers receive a COVID–19 PCR or rapid
antigen test no more than 2 days before boarding
or on embarkation day. See https://www.cdc.gov/
quarantine/cruise/covid19-operations-manualcso.html. While cruise ships share similarities with
other forms of travel, including air travel, cruise
ships represent a unique environment that
facilitates the spread of COVID–19 based on such
factors as their larger size, with larger cruises of
more than 6,000 passengers, and ability to bring an
international cohort of passengers and crew
together for days or weeks at a time through
frequent events such as group and buffet dining,
entertainment events, and excursions. Accordingly,
testing, and other public health recommendations
for cruise ships and air travel may differ.
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pharmacy, or other qualified entity.
Some governments and private
industries have developed vaccination
credentials that are considered
‘‘verifiable’’ because they can be
electronically linked back to a person’s
vaccination data held by a trusted
source. The trusted source is able to
then confirm the authenticity and
validity of the certificate and/or confirm
that the vaccination took place. An
example of verifiable vaccination
credentials is a QR code image on paper
or in digital format, such as on a mobile
phone, that links to the person’s verified
vaccination data.
Considering the variability of vaccine
credentials globally, this Amended
Order provides the airline or aircraft
operator the discretion to accept
different forms of vaccine credentials,
whether paper, digital, or verifiable, for
passengers who submit a Qualifying
Test for Fully Vaccinated accompanied
by Proof of Being Fully Vaccinated
Against COVID–19. While this
Amended Order may be enforced
through criminal penalties under 18
U.S.C. 3559, 3571; 42 U.S.C. 271; and 42
CFR 71.2, CDC does not intend to rely
on this enforcement mechanism for
airlines or aircraft operators who accept
paper or digital documentation of
vaccination (i.e., paper or digital
vaccination records, verifiable
vaccination credential) from a passenger
in good faith and use best efforts to
fulfill the requirements of this Amended
Order.
G. Statement of Good Cause Under the
Administrative Procedure Act (‘‘APA’’)
COVID–19 cases, hospitalizations,
and deaths rapidly increased over the
summer and early fall of 2021,
especially in areas with higher levels of
community transmission and lower
vaccination coverage.57 Pediatric cases
and hospitalizations also increased over
the same time period.58 59 While cases
are currently decreasing in the United
57 Scobie HM, Johnson AG, Suthar AB, Severson
R, Alden NB, Balter S, Bertolino D, Blythe D, Brady
S, Cadwell B, Cheng I. Monitoring incidence of
covid–19 cases, hospitalizations, and deaths, by
vaccination status—13 US jurisdictions, April 4–
July 17, 2021. Morbidity and Mortality Weekly
Report. 2021 Sep 17;70(37):1284.
58 Delahoy MJ, Ujamaa D, Whitaker M, O’Halloran
A, Anglin O, Burns E, Cummings C, Holstein R,
Kambhampati AK, Milucky J, Patel K.
Hospitalizations associated with COVID–19 among
children and adolescents—COVID–NET, 14 states,
March 1, 2020–August 14, 2021. Morbidity and
Mortality Weekly Report. 2021 Sep 10;70(36):1255.
59 Siegel DA, Reses HE, Cool AJ et al. Trends in
COVID–19 cases, emergency department visits, and
hospital admissions among children and
adolescents aged 0–17 years—United States, August
2020–August 2021. Morbidity and Mortality Weekly
Report. 2021 Sep 10;70(36):1249.
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States, during the entirety of this
pandemic, cases have tended to surge in
waves, including after high-volume
travel periods, with 4 waves as of
October 2021.18 Therefore, additional
surges of cases and deaths are very
possible.
To reduce introduction and spread of
future SARS–CoV–2 variants into the
United States at a time when global air
travel is increasing, CDC must take
quick and targeted action to curtail the
introduction of other new variants into
the United States.
This Amended Order is not a rule
within the meaning of the
Administrative Procedure Act (‘‘APA’’)
but rather is an emergency action taken
under the existing authority of 42 U.S.C.
264(a) and 42 CFR 71.20 and 71.31(b),
which were promulgated in accordance
with the APA after full notice and
comment rulemaking and a delay in
effective date. In the event that this
Amended Order qualifies as a new 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
comment and a delay in effective date.
See 5 U.S.C. 553(b)(B), (d)(3).
Considering the rapid and
unpredictable developments in the
public health emergency caused by
COVID–19, 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 Amended Order. Further delay
could increase risk of transmission and
importation of additional undetected
cases of SARS–CoV–2 Delta variant or
other emerging variants through not
fully vaccinated passengers who become
infectious during the 3-day window
currently allowed for predeparture
testing.
Similarly, the Office of Information
and Regulatory Affairs has determined
that if this Amended Order were a rule,
it would be a major rule under Subtitle
E of the Small Business Regulatory
Enforcement Fairness Act of 1996 (the
Congressional Review Act), 5 U.S.C.
804(2), but there would not be a delay
in its effective date as the agency has
determined that there would be good
cause to make the requirements herein
effective immediately under the APA, 5
U.S.C. 808(2).
This Amended Order is also an
economically significant regulatory
action under Executive Order 12866 and
has therefore been reviewed by the
Office of Information and Regulatory
Affairs of the Office of Management and
Budget.
If any provision of this Amended
Order, or the application of any
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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.
Pursuant to 5 U.S.C. 553(b)(B), and for
the reasons stated above, I hereby
conclude that notice-and-comment
rulemaking would defeat the purpose of
the Amended Order and endanger the
public health, and is, therefore,
impracticable and contrary to the public
interest. For the same reasons, I have
determined, consistent with 5 U.S.C.
553(d)(3), that there is good cause to
make this Amended Order effective
immediately upon filing at the Office of
the Federal Register.
Action
For the reasons outlined above, I
hereby determine that passengers
covered by this Amended Order are at
risk of transmitting SARS–CoV–2 virus,
including virus variants, and that
requiring such passengers to
demonstrate either negative COVID–19
test results or recovery from COVID–19
after previous SARS–CoV–2 infection is
needed as a public health measure to
protect the health of fellow travelers and
U.S. communities. These actions are
necessary to reduce the risk of
transmission of new SARS–CoV–2
virus, including virus variants, and to
protect the health of fellow travelers and
U.S. communities.
This Amended Order shall remain
effective until either the expiration of
the Secretary of HHS’ declaration that
COVID–19 constitutes a public health
emergency, or I determine that based on
specific public health or other
considerations that continuation of this
Order is no longer necessary to prevent
the further introduction, transmission,
and spread of COVID–19 into the United
States, whichever occurs first. Upon
determining that continuation of this
Order is no longer necessary to prevent
the further introduction, transmission,
and spread of COVID–19 into the United
States, I will publish a notice in the
Federal Register terminating this Order.
I retain the authority to modify or
terminate the Order, or its
implementation, at any time as needed
to protect public health.
1. Requirements for Airlines & Other
Aircraft Operators
Any airline or other aircraft operator
with passengers arriving into the United
States from a foreign country, shall:
A. Confirm that every passenger—2
years or older—onboard the aircraft has
paper or digital documentation
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reflecting a Qualifying Test for Fully
Vaccinated, a Qualifying Test for Not
Fully Vaccinated, or Documentation of
Recovery.
(1) Requirements for a Qualifying Test
for Fully Vaccinated include:
a. Documentation of a negative SARS–
CoV–2 viral test result from a specimen
collected no more than 3 calendar days
preceding the passenger’s flight to the
United States. The negative SARS–CoV–
2 viral test result should include:
i. Personal identifiers (e.g., name and
date of birth) on the negative test result
that match the personal identifiers on
the passenger’s passport or other travel
documents;
ii. a specimen collection date
indicating that the specimen was
collected no more than 3 days before the
flight’s departure (or first flight in a
series of connections booked on the
same itinerary); 60
iii. type of viral test indicating it is a
NAAT or antigen test;
iv. a test result that states
‘‘NEGATIVE,’’ ‘‘SARS–CoV–2 RNA
NOT DETECTED,’’ ‘‘SARS–CoV–2
ANTIGEN NOT DETECTED,’’ or
‘‘COVID–19 NOT DETECTED,’’ or other
indication that SARS–CoV–2 was not
detected in the individual’s specimen. A
test marked ‘‘invalid’’ is not acceptable;
and
v. information about the entity issuing
the result (e.g., laboratory, healthcare
entity, or telehealth service), such as the
name and contact information; and
b. Proof of Being Fully Vaccinated
Against COVID–19 against COVID–19 as
defined in this Amended Order, that
includes personal identifiers (e.g., name
and date of birth) that match the
personal identifiers on the passenger’s
passport or other travel documents.
(2) Requirements for a Qualifying Test
for Not Fully Vaccinated include:
a. Documentation of a negative SARS–
CoV–2 viral test result from a specimen
collected no more than 1 day preceding
the passenger’s flight to the United
States. The negative SARS–CoV–2 viral
test result should include:
i. Personal identifiers (e.g., name and
date of birth) on the negative test result
that match the personal identifiers on
the passenger’s passport or other travel
documents;
ii. specimen collection date indicating
that the specimen was collected no
more than 1 day before the flight’s
departure (or first flight in a series of
60 Passengers traveling on a series of connections
booked on the same itinerary also have the option
of obtaining the required negative test result en
route to the United States if testing within the
required time frame is not available at their point
of origin.
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connections booked on the same
itinerary); 61
iii. type of viral test indicating it is a
NAAT or antigen test;
iv. a test result that states
‘‘NEGATIVE,’’ ‘‘SARS–CoV–2 RNA
NOT DETECTED,’’ ‘‘SARS–CoV–2
ANTIGEN NOT DETECTED,’’ or
‘‘COVID–19 NOT DETECTED,’’ or other
indication that SARS–CoV–2 was not
detected in the individual’s specimen. A
test marked ‘‘invalid’’ is not acceptable;
and
v. information about the entity issuing
the result (e.g., laboratory, healthcare
entity, or telehealth service), such as the
name and contact information.
(3) Requirements for Documentation
of Recovery include:
a. Documentation of a positive SARS–
CoV–2 viral test result from a specimen
collected no more than three months (90
calendar days) preceding the
passenger’s flight to the United States,
or at such other intervals as specified in
CDC guidance. 62 The positive SARS–
CoV–2 viral test result should include:
i. Personal identifiers (e.g., name and
date of birth) on the positive test result
match the personal identifiers on the
passenger’s passport or other travel
documents;
ii. a specimen collection date
indicating that the specimen was
collected no more than 90 calendar days
before the flight’s departure;
iii. information that the test
performed was a viral test indicating it
is a NAAT or antigen test;
iv. a test result that states
‘‘POSITIVE,’’ ‘‘SARS–CoV–2 RNA
DETECTED,’’ ‘‘SARS–CoV–2 ANTIGEN
DETECTED,’’ or ‘‘COVID–19
DETECTED,’’ or other indication that
SARS–CoV–2 was detected in the
individual’s specimen. A test marked
‘‘invalid’’ is not acceptable; and
v. information about the entity issuing
the result (e.g., laboratory, healthcare
entity, or telehealth service), such as the
name and contact information.
b. A signed letter from a licensed
healthcare provider or a public health
official stating that the passenger has
been cleared for travel.63 64 The letter
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61 Ibid.
62 Interim Guidance on Ending Isolation and
Precautions for Adults with COVID–19 https://
www.cdc.gov/coronavirus/2019-ncov/hcp/durationisolation.html.
63 Healthcare providers and public health officials
should follow CDC guidance in clearing patients for
travel to the United States. Applicable guidance is
available at https://www.cdc.gov/coronavirus/2019ncov/hcp/disposition-in-home-patients.html.
64 A letter from a healthcare provider or a public
health official that clears the person to end
isolation, e.g., to return to work or school, can also
be used to show that the person has been cleared
to travel, even if travel is not specifically mentioned
in the letter.
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must have personal identifiers (e.g.,
name and date of birth) that match the
personal identifiers on the passenger’s
passport or other travel documents. The
letter must be signed and dated on
official letterhead that contains the
name, address, and phone number of
the healthcare provider or public health
official who signed the letter.
B. Confirm that each passenger has
attested to having received a negative
result for a Qualifying Test for Fully
Vaccinated plus being fully vaccinated,
a negative result for a Qualifying Test
for Not Fully Vaccinated, or having
tested positive for SARS–CoV–2 on a
specimen collected no more than 90
calendar days before the flight and been
cleared to travel. Airlines or other
aircraft operators must retain a copy of
each passenger attestation for 2 years.
The attestation is attached to this order
as Attachment A.
C. Not board any passenger without
confirming the documentation as set
forth in A and B.
Any airline or other aircraft operator
that fails to comply with section 1,
‘‘Requirements for Airlines & Other
Aircraft Operators,’’ may be subject to
criminal penalties under, inter alia, 42
U.S.C. 271 and 42 CFR 71.2, in
conjunction with 18 U.S.C. 3559 and
3571. However, CDC does not intend to
rely on this enforcement mechanism for
airlines or aircraft operators who accept
paper or digital documentation of
vaccination (i.e., paper or digital
vaccination records, or verifiable
vaccination credential) from a passenger
in good faith and use best efforts to
fulfill the requirements of this Amended
Order.
2. Requirements for Aircraft Passengers
Any aircraft passenger 65 66 departing
from any foreign country with a
destination in the United States shall—
A. Present paper or digital
documentation reflecting one of the
following:
65 A parent or other authorized individual may
present the required documentation on behalf of a
passenger 2–17 years of age. An authorized
individual may act on behalf of any passenger who
is unable to act on their own behalf (e.g., by reason
of age, or physical or mental impairment).
66 Children between the ages of 2 and 17 who are
not fully vaccinated may board a flight to the
United States with a negative pre-departure
COVID–19 viral test conducted on a specimen
collected no more than 3 calendar days before
departure (i.e., Qualifying Test for Fully
Vaccinated) if traveling accompanied by fully
vaccinated parents or guardians. If traveling
unaccompanied or if one or more of the parents or
guardians accompanying the child is not fully
vaccinated, the child must present a negative predeparture COVID–19 viral test on a specimen
collected no more than 1 day before departure (i.e.,
a Qualifying Test for Not Fully Vaccinated).
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(1) A negative Qualifying Test for
Fully Vaccinated that has a specimen
collection date indicating that the
specimen was collected no more than 3
calendar days before the flight’s
departure (or first flight in a series of
connections booked on the same
itinerary) 67 plus Proof of Being Fully
Vaccinated Against COVID–19 against
COVID–19;
(2) A negative Qualifying Test for Not
Fully Vaccinated that has a specimen
collection date indicating that the
specimen was collected no more than 1
day before the flight’s departure (or first
flight in a series of connections booked
on the same itinerary); 68 or
(3) Documentation of Recovery from
COVID–19 that includes a positive
SARS–CoV–2 viral test result conducted
on a specimen collected no more than
90 calendar days before the flight and a
letter from a licensed healthcare
provider or public health official stating
that the passenger has been cleared for
travel.69 70
B. Provide the attestation to the
airline or other aircraft operator, of one
of the following:
(1) having received a negative result
for the Qualifying Test for Vaccinated
and being fully vaccinated against
COVID–19;
(2) having received a negative result
for the Qualifying Test for Not Fully
Vaccinated; or
(3) having tested positive for SARSCoV–2 on a specimen collected no more
than 90 calendar days before the flight
and been cleared to travel.
The attestation is attached to this
order as Attachment A. Unless
otherwise permitted by law, a parent or
other authorized individual may present
the required documentation on behalf of
a passenger 2–17 years of age. An
authorized individual may act on behalf
of any passenger who is unable to act on
their own behalf (e.g., by reason of age,
or physical or mental impairment).
C. Retain a copy of the applicable
documentation listed in part A of this
section and produce such
67 Passengers traveling on a series of connections
booked on the same itinerary also have the option
of obtaining the required negative test result en
route to the United States if testing within the
required time frame is not available at their point
of origin.
68 Ibid.
69 A letter from a healthcare provider or a public
health official that clears the person to end
isolation, e.g., to return to work or school, can also
be used to show that the person has been cleared
to travel, even if travel is not specifically mentioned
in the letter.
70 Healthcare providers and public health officials
should follow CDC guidance in clearing patients for
travel to the United States. Applicable guidance is
available at https://www.cdc.gov/coronavirus/2019ncov/hcp/disposition-in-home-patients.html.
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documentation upon request to any U.S.
government official or a cooperating
state or local public health authority
after arrival in the United States.
Any passenger who fails to comply
with the requirements of section 2,
‘‘Requirements for Aircraft Passengers,’’
may be subject to criminal penalties
under, inter alia, 42 U.S.C. 271 and 42
CFR 71.2, in conjunction with 18 U.S.C.
3559 and 3571. Willfully giving false or
misleading information to the
government may result in criminal
penalties under, inter alia, 18 U.S.C.
1001.
This Amended Order shall be
enforceable through the provisions of 18
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U.S.C. 3559, 3571; 42 U.S.C. 243, 268,
271; and 42 CFR 71.2.
As the pandemic continues to rapidly
evolve and more scientific data becomes
available regarding additional variants
of concern and/or the effectiveness of
COVID–19 vaccines, CDC may exercise
its enforcement discretion to broaden
the scope of accepted vaccines or
combinations of accepted vaccines to
allow passengers and airline and aircraft
operators greater flexibility regarding
the requirements of this Amended Order
or to align with current CDC guidance.
Such exercises of enforcement
discretion will be announced on CDC’s
website and the Amended Order will be
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further amended as soon as practicable
through an updated publication in the
Federal Register.
Effective Date
This Amended Order shall enter into
effect at 12:01am EST (5:01am GMT) on
November 8, 2021, and will remain in
effect unless modified or rescinded
based on specific public health or other
considerations, or until the Secretary of
Health and Human Services rescinds the
determination under section 319 of the
Public Health Service Act (42 U.S.C.
247d) that a public health emergency
exists with respect to COVID–19.
BILLING CODE 4163–18–P
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61276
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices
Sherri Berger,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2021–24388 Filed 11–3–21; 4:15 pm]
BILLING CODE 4163–18–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB #0970–0529]
Proposed Information Collection
Activity; Prevention Services Data
Collection
Children’s Bureau,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), Children’s
Bureau is requesting a 3-year extension
of the Prevention Services Data
Collection (OMB #0970–0529,
expiration 7/31/2022). There are no
changes requested to the form.
DATES: Comments due within 60 days of
publication. In compliance with the
SUMMARY:
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Section 471(e)(4)(E) of
the Social Security Act (the Act) (42
U.S.C. 671), as amended by Public Law
115–123, requires state and tribal child
welfare agencies to collect and report to
ACF information on children receiving
prevention and family services and
programs. Title IV–E Agencies must
report the following:
• The specific services or programs
provided.
• The total expenditures for each of
the services or programs provided.
• The duration of the services or
programs provided, and
• If the child was identified in a
prevention plan as a candidate for foster
care:
Æ The child’s placement status at the
beginning, and at the end, of the 12month period that begins on the date the
child was identified as a candidate for
foster care in a prevention plan; and
Æ Whether the child entered foster
care during the initial 12-month period
and during the subsequent 12-month
period.
To date, approximately 3⁄4 of the Title
IV–E Agencies have chosen to provide
these prevention services; however, it is
believed that this number will continue
to increase over time as states
voluntarily opt-in to the program in
order to utilize IV–E funding to provide
prevention programs and services to
children and families.
The data collected will continue to
inform federal policy decisions,
program management, and responses to
Congressional and Departmental
inquiries. Specifically, the data will
provide information about the use and
availability of prevention services to
children to prevent the need for foster
care placement. The data contains
personally identifiable information (date
of birth and race/ethnicity).
Respondents: Title IV–E Agencies.
jspears on DSK121TN23PROD with NOTICES1
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Annual
burden hours
Prevention Services Data Collection ...................................
55
2
31
3,410
1,137
Estimated Total Annual Burden
Hours: 1,137.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 471(e)(4)(E) of the
Act (42 U.S.C. 671), as amended by
Public Law 115–123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–24224 Filed 11–4–21; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Request for Certification of
Adult Victims of Human Trafficking
Office on Trafficking in
Persons, Administration for Children
and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), Office on
Trafficking in Persons (OTIP), is
SUMMARY:
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requesting a 3-year extension of the
Request for Certification of Adult
Victims of Human Trafficking (RFC)
form (Office of Management and Budget
(OMB) #: 0970–0454, expiration 2/28/
22). Minor revisions have been made to
the form, including the addition of a few
fields that will enable OTIP to be more
responsive to congressional inquiries,
federal reporting requirements, and the
needs of victims.
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
DATES:
You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05NON1.SGM
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Agencies
[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61252-61276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Requirement for Negative Pre-Departure COVID-19 Test Result or
Documentation of Recovery From COVID-19 for All Airline or Other
Aircraft Passengers Arriving Into the United States From Any Foreign
Country
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of agency amended order.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces an
Amended Order requiring negative pre-departure COVID-19 test results or
documentation of recovery from COVID-19 for all airline or other
aircraft passengers arriving into the United States from any foreign
country. This Amended Order was signed by the CDC Director on October
25, 2021, and supersedes the previous Order signed by the CDC Director
on January 25, 2021.
DATES: This Amended Order will become effective at 12:01 a.m. on
November 8, 2021.
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. Telephone: 404-498-
1600. Email: [email protected].
SUPPLEMENTARY INFORMATION: This Amended Order updates COVID-19 testing
requirements for air passengers 2 years of age and older boarding a
flight to the United States, depending on their COVID-19 vaccination
status.
This Amended Order prohibits the boarding of any passenger 2 years
of age and older on any airline or aircraft destined to the United
States from a foreign country unless the passenger presents:
(1) Paper or digital documentation of a negative pre-departure
viral test result for SARS-CoV-2, the virus that causes COVID-19, that
meets one of the following requirements:
For passengers who are fully vaccinated against COVID-19,
the viral test must be conducted on a specimen collected no more than 3
days before the flight's departure from a foreign country.
For passengers not fully vaccinated against COVID-19, the
viral test must be conducted on a specimen collected no more than 1 day
before the flight's departure from a foreign country.
Or
(2) Paper or digital documentation of recovery from COVID-19 in the
form of both:
A positive viral test result conducted on a specimen
collected no more than 90 days before the flight; and
A letter from a licensed health care provider or public
health official stating that the passenger has been cleared for travel.
This Amended Order also constitutes a controlled free pratique to
any airline or other aircraft operator with an aircraft arriving into
the United States. Pursuant to this controlled free pratique, the
airline or other aircraft operator must comply with the requirements
outlined in the Amended Order.
A copy of the Amended Order and Passenger Attestation form is
provided below. A copy of the signed Amended Order and Passenger
Attestation form can be found at https://www.cdc.gov/quarantine/fr-proof-negative-test.html.
Centers for Disease Control and Prevention (CDC), Department of Health
and Human Services (HHS)
Notice and Amended Order Under Section 361 of the Public Health Service
Act (42 U.S.C. 264) and 42 Code of Federal Regulations 71.20 & 71.31(b)
Requirement for Negative Pre-Departure COVID-19 Test Result or
Documentation of Recovery From COVID-19 for All Airline or Other
Aircraft Passengers Arriving Into the United States From Any Foreign
Country
Summary
Pursuant to 42 CFR 71.20, 71.31(b) and as set forth in greater
detail below, this Notice and Amended Order \1\ prohibits the boarding
of any passenger--2 years of age or older--on any aircraft destined to
the United States \2\ from a foreign country unless the passenger \3\
presents:
---------------------------------------------------------------------------
\1\ This Amended Order supersedes the previous order signed by
the Centers for Disease Control and Prevention (CDC) Director on
January 25, 2021.
\2\ This includes any flight, regardless of whether the United
States is final destination or connection to another country.
\3\ A parent or other authorized individual may present the
required documentation on behalf of a passenger 2-17 years of age.
An authorized individual may act on behalf of any passenger who is
unable to act on their own behalf (e.g., by reason of age, or
physical or mental impairment).
---------------------------------------------------------------------------
(1) Paper or digital documentation of a negative pre-departure
viral test result for SARS-CoV-2, the virus that causes COVID-19, that
meets one of the following requirements:
For passengers who are fully vaccinated against COVID-19,
the viral test must be conducted on a specimen collected no more than 3
calendar days before the flight's departure from a foreign country
(Qualifying Test for Fully Vaccinated).
For passengers who are not fully vaccinated against COVID-
19, the viral test must be conducted on a specimen collected no more
than 1 calendar day before the flight's departure from a foreign
country (Qualifying Test for Not Fully Vaccinated).
Or
(2) Paper or digital documentation of recovery from COVID-19 in the
form of both:
[[Page 61253]]
A positive viral test result conducted on a specimen
collected no more than 90 calendar days before the flight; and
A letter from a licensed healthcare provider or public
health official stating that the passenger has been cleared for travel
(Documentation of Recovery).
The option to present Documentation of Recovery is available to
passengers regardless of their vaccination status.
Passengers who have a Qualifying Test for Fully Vaccinated, i.e., a
negative pre-departure viral test conducted on a specimen collected no
more than 3 calendar days before the flight's departure from a foreign
country, must have paper or digital documentation of being fully
vaccinated with an Accepted COVID-19 Vaccine (Proof of Being Fully
Vaccinated Against COVID-19).
Passengers who have a Qualifying Test for Not Fully Vaccinated,
i.e., a negative pre-departure viral test conducted on a specimen
collected no more than 1 calendar day before the flight's departure
from a foreign country, do not need to present Proof of Being Fully
Vaccinated Against COVID-19.
Alternatively, if a passenger has tested positive for SARS-CoV-2 on
a specimen collected no more than 90 calendar days before the flight's
departure and recovered from COVID-19 (i.e., met CDC criteria to end
isolation),\4\ the passenger may instead travel with paper or digital
documentation of the positive viral test result that confirms the
previous SARS-CoV-2 infection and a letter from a licensed healthcare
provider or public health official stating that the passenger has been
cleared for travel (Documentation of Recovery).
---------------------------------------------------------------------------
\4\ https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html.
---------------------------------------------------------------------------
Each passenger must retain paper or digital documentation presented
to the airline or other aircraft operator reflecting one of the
following:
Negative result for Qualifying Test for Fully Vaccinated
plus Proof of Being Fully Vaccinated Against COVID-19;
Negative result for the Qualifying Test for Not Fully
Vaccinated; or
Documentation of Recovery from COVID-19.
A passenger, or the passenger's authorized representative, must
also produce such documentation upon request to any U.S. government
official or a cooperating state or local public health authority.
Pursuant to 42 CFR 71.31(b) and as set forth in greater detail
below, this Notice and Amended Order constitute a controlled free
pratique to any airline or other aircraft operator with an aircraft
arriving in the United States.\5\ Pursuant to this controlled free
pratique, the airline or other aircraft operator must comply with the
following conditions to receive permission for the aircraft to enter
and disembark passengers in the United States:
---------------------------------------------------------------------------
\5\ On October 25, 2021, the President issued a Proclamation
pursuant to Sections1182(f) and 1185(a)(1) of Title 8, and Section
301 of Title 3, United States Code, titled, ``Advancing the Safe
Resumption of Global Travel During the COVID-19 Pandemic.'' Pursuant
to this Proclamation. The President has implemented a global
suspension and restriction on entry for noncitizens who are
nonimmigrants seeking to enter the United States by air travel and
who are not fully vaccinated against COVID-19. This amended CDC
Order complements and advances the safe resumption of global travel.
---------------------------------------------------------------------------
Airline or other aircraft operator must confirm that every
passenger onboard the aircraft based on vaccination status has
documentation of a negative result for a Qualifying Test for Fully
Vaccinated plus Proof of Being Fully Vaccinated Against COVID-19, a
negative result for a Qualifying Test for Not Fully Vaccinated, or
Documentation of Recovery.
Airline or other aircraft operator must verify that every
passenger onboard the aircraft based on vaccination status has attested
to receiving a negative result for the Qualifying Test for Fully
Vaccinated plus being fully vaccinated, receiving a negative result for
the Qualifying Test for Not Fully Vaccinated, or having tested positive
for SARS-CoV-2 on a specimen collected no more than 90 calendar days
before the flight and been cleared to travel as Documentation of
Recovery.\6\
---------------------------------------------------------------------------
\6\ A parent or other authorized individual may present the
required documentation on behalf of a passenger 2-17 years of age.
An authorized individual may act on behalf of any passenger who is
unable to act on their own behalf (e.g., by reason of age, or
physical or mental impairment).
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Statement of Intent
This Order shall be interpreted and implemented to achieve the
following paramount objectives:
Preservation of human life;
Preventing the further introduction, transmission, and
spread of the virus that causes COVID-19 into the United States,
including new virus variants;
Preserving the health and safety of crew members,
passengers, airport personnel, and communities; and
Preserving hospital, healthcare, and emergency response
resources within the United States.
Definitions
Accepted COVID-19 Vaccine means:
A vaccine authorized for emergency use or approved by the
U.S. Food and Drug Administration; \7\ or
---------------------------------------------------------------------------
\7\ For a list of vaccines approved or authorized in the United
States to prevent COVID-19, see https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html.
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A vaccine listed for emergency use by the World Health
Organization (WHO); \8\ or
---------------------------------------------------------------------------
\8\ See WHO's website for more information about WHO emergency
use-listed COVID-19 vaccines.
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A vaccine or combination of vaccines \9\ listed by CDC in
CDC's Technical Instructions for Implementing Presidential Proclamation
Advancing Safe Resumption of Global Travel During the COVID-19 Pandemic
and CDC's Order.
---------------------------------------------------------------------------
\9\ CDC has not recommended the use of heterologous (i.e., mix-
and-match) primary series. However, the use of such strategies
(including mixing of mRNA, adenoviral, and mRNA plus adenoviral
products) is increasingly common in many countries outside of the
United States. Accordingly, additional vaccinations or combinations
of vaccinations may be listed in CDC's in Technical Instructions for
Implementing Presidential Proclamation Advancing Safe Resumption of
Global Travel During the COVID-19 Pandemic and CDC's Order for
purposes of the interpretation of vaccination records.
---------------------------------------------------------------------------
Aircraft shall have the same definition as under 49 U.S.C.
40102(a)(6). ``Aircraft'' includes, but is not limited to, commercial,
general aviation, and private aircraft destined for the United States
from a foreign country.
Aircraft Operator means an individual or organization causing or
authorizing the operation of an aircraft.
Airline shall have the same definition as under 42 CFR 71.1(b).
Attest/Attestation means having completed the attestation in
Attachment A.\10\ Such attestation may be completed in paper or digital
form. The attestation is a statement, writing, entry, or other
representation under 18 U.S.C. 1001.\11\
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\10\ CDC has provided a combined passenger disclosure and
attestation that fulfills the requirements of CDC Orders:
Requirement for Proof of Negative COVID-19 Test Result or Recovery
from COVID-19 for All Airline Passengers Arriving into the United
States and Order Implementing Presidential Proclamation on Advancing
the Safe Resumption of Global Travel During the COVID-19 Pandemic.
\11\ CDC encourages airlines and aircraft operators to
incorporate the attestation into paperless check-in processes. An
airline or aircraft operator may use a third party (including a
third-party application) to collect attestations, including to
provide translations. However, an airline or aircraft operator has
sole legal responsibility to provide and collect attestations, to
ensure the accuracy of any translation, and to comply with all other
obligations under this Order. An airline or aircraft operator is
responsible for any failure of a third party to comply with this
Order. An airline or aircraft operator may not shift any legal
responsibility to a third party.
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Documentation of Recovery means paper or digital documentation of
recovery from COVID-19 in the form of a positive SARS-CoV-2 viral test
result
[[Page 61254]]
and a letter from a licensed healthcare provider or public health
official stating that the person has been cleared for travel (i.e., has
recovered).12 13 The viral test must have been conducted on
a specimen collected no more than 90 calendar days before the departure
of the flight.
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\12\ Healthcare providers and public health officials should
follow CDC guidance in clearing patients for travel to the United
States. Applicable guidance is available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html.
\13\ A letter from a healthcare provider or a public health
official that clears the person to end isolation (e.g., to return to
work or school), can also be used to show that the person has been
cleared to travel, even if travel is not specifically mentioned in
the letter.
---------------------------------------------------------------------------
Foreign country means anywhere that is not a state, territory, or
possession of the United States.
Fully Vaccinated Against COVID-19 means it has been:
2 weeks (14 days) or more since a person received one dose
of an accepted single-dose series COVID-19 vaccine; OR
2 weeks (14 days) or more since a person's second dose in
a 2-dose series of an accepted COVID-19 vaccine; OR
2 weeks (14 days) or more since a person received a
complete series of a vaccine or combination of vaccines listed by CDC
in CDC's Technical Instructions for Implementing Presidential
Proclamation Advancing Safe Resumption of Global Travel During the
COVID-19 Pandemic and CDC's Order.
Not Fully Vaccinated Against COVID-19 means a person does not meet
the definition of Fully Vaccinated Against COVID-19.
Proof of Being Fully Vaccinated against COVID-19 means a person has
an acceptable paper or digital format of a vaccination record or a
verifiable vaccination record confirming that the person is Fully
Vaccinated Against COVID-19 as defined and listed by CDC in CDC's
Technical Instructions for Implementing Presidential Proclamation
Advancing Safe Resumption of Global Travel During the COVID-19 Pandemic
and CDC's Order.
Qualifying Test for Fully Vaccinated means a negative result on a
SARS-CoV-2 viral test that was conducted on a specimen collected no
more than 3 calendar days before the flight's departure from a foreign
country to the United States for passengers who have Proof of Being
Fully Vaccinated Against COVID-19.
Qualifying Test for Not Fully Vaccinated means a negative result on
a SARS-CoV-2 viral test that was conducted on a specimen collected no
more than 1 calendar day before the flight's departure from a foreign
country to the United States for passengers who do not have Proof of
Being Fully Vaccinated Against COVID-19.
United States has the same definition as ``United States'' in 42
CFR 71.1(b), meaning ``the 50 States, District of Columbia, and the
territories (also known as possessions) of the United States, including
American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of
Puerto Rico, and the U.S. Virgin Islands.''
Viral test means a viral detection test for current infection
(i.e., a nucleic acid amplification test [NAAT] or a viral antigen
test) approved or authorized by the relevant national authority or the
U.S. Food and Drug Administration for the detection of SARS-CoV-2.
Exemptions
The following categories of individuals and organizations are
exempt from the requirements of this Amended Order:
Crew members of airlines or other aircraft operators if
they follow industry standard protocols for the prevention of COVID-19
as set forth in relevant Safety Alerts for Operators (SAFOs) issued by
the Federal Aviation Administration (FAA).\14\
---------------------------------------------------------------------------
\14\ Airlines, aircraft operators, and their crew members may
follow stricter protocols for crew and passenger health, including
testing protocols. SAFO 20009, COVID-19: Updated Interim
Occupational Health and Safety Guidance for Air Carriers and Crews,
available at https://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/safo/all_safos/media/2020/SAFO20009.pdf.
---------------------------------------------------------------------------
Airlines or other aircraft operators transporting
passengers with COVID-19 pursuant to CDC authorization and in
accordance with CDC guidance.\15\
---------------------------------------------------------------------------
\15\ Interim Guidance for Transporting or Arranging
Transportation by Air into, from, or within the United States of
People with COVID-19 or COVID-19 Exposure, available at https://www.cdc.gov/quarantine/interim-guidance-transporting.html.
---------------------------------------------------------------------------
U.S. federal law enforcement personnel on official orders
who are traveling for the purpose of carrying out a law enforcement
function, provided they are covered under an occupational health and
safety program that takes measures to ensure personnel are not
symptomatic or otherwise at increased risk of spreading COVID-19 during
travel. Those traveling for training or other business purposes remain
subject to the requirements of this Order.
U.S. military personnel, including civilian employees,
dependents, contractors, and other U.S. government employees when
traveling on U.S. military assets (including whole aircraft charter
operators), if such individuals are under competent military or U.S
government travel orders and observing U.S. Department of Defense
guidance to prevent the transmission of COVID-19 as set forth in Force
Protection Guidance Supplement 20--Department of Defense Guidance for
Personnel Traveling During the Coronavirus Disease 2019 Pandemic (April
12, 2021) including its testing guidance.\16\
---------------------------------------------------------------------------
\16\ Force Protection Guidance Supplement 20--Department of
Defense Guidance for Personnel Traveling During the Coronavirus
Disease 2019 Pandemic, available at https://media.defense.gov/2021/Apr/16/2002622876/-1/-1/1/MEMORANDUM-FOR-FORCE-HEALTH-PROTECTION-GUIDANCE-SUPPLEMENT%2020-DEPARTMENT-OF-DEFENSE-GUIDANCE-FOR-PERSONNEL-TRAVELING-DURING-THE-CORONAVIRUS-DISEASE-2019-PANDEMIC.PDF.
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Individuals and organizations for which the issuance of a
humanitarian exemption is necessary based on both: (1) Exigent
circumstances where emergency travel is required to preserve health and
safety (e.g., emergency medical evacuations) and (2) where pre-
departure testing cannot be accessed or completed before travel because
of exigent circumstances. Additional conditions may be placed on those
granted such exemptions, including but not limited to, observing
precautions during travel, providing consent to post-arrival testing,
and/or self-quarantine after arrival in the United States, as may be
directed by federal, state, territorial, tribal or local public health
authorities to reduce the risk of transmission.
Background
A. COVID-19 Pandemic
Since January 2020, the respiratory disease known as ``COVID-19,''
caused by a novel coronavirus (SARS-CoV-2), has spread globally,
including cases reported in all 50 states within the United States,
plus the District of Columbia and all U.S. territories. As of October
22, 2021, there have been over 242,000,000 million cases of COVID-19
globally, resulting in over 4,900,000deaths.\17\ More than 45,000,000
cases have been identified in the United States, with new cases
reported daily, and over 733,000 deaths have been attributed to the
disease. A renewed surge in cases in the United States began in early
July 2021; daily case counts rose from 19,000 cases on July 1, 2021 to
159,000 cases on September 1, 2021. While cases are currently
decreasing in the United States, during the entirety of this pandemic,
cases have tended to surge in waves, including after high-volume travel
periods, with 4 waves as of October 2021.\18\ Therefore, additional
[[Page 61255]]
surges of cases and deaths are very possible.
---------------------------------------------------------------------------
\17\ https://covid19.who.int/.
\18\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
---------------------------------------------------------------------------
Many countries have begun widespread vaccine administration;
however, 98 countries continue to experience high or substantial
incidence rates (>50 cases per 100,000 people in the last seven days)
and 65 countries, including the United States, are experiencing a high
incidence of reported new cases at this time.\19\
---------------------------------------------------------------------------
\19\ https://covid19.who.int/.
---------------------------------------------------------------------------
SARS-CoV-2 spreads mainly from person-to-person through respiratory
fluids released during exhalation, such as when an infected person
coughs, sneezes, or talks.
Exposure to these respiratory fluids occurs in three principal
ways: (1) Inhalation of very fine respiratory droplets and aerosol
particles, (2) deposition of respiratory droplets and particles on
exposed mucous membranes in the mouth, nose, or eye by direct splashes
and sprays, and (3) touching mucous membranes with hands that have been
soiled either directly by virus-containing respiratory fluids or
indirectly by touching surfaces with virus on them.20 21
Spread is more likely when people are in close contact with one another
(within about 6 feet), especially in crowded or poorly ventilated
indoor settings. Persons who are not fully vaccinated, including those
with asymptomatic or pre-symptomatic infections, are significant
contributors to community SARS-CoV-2 transmission and occurrence of
COVID-19.22 23
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\20\ Scientific Brief: SARS-CoV-2 Transmission, Centers for
Disease Control and Prevention (May 7, 2021), https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html.
\21\ Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission
for Indoor Community Environments, Centers for Disease Control and
Prevention (Apr. 5, 2021), https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html.
\22\ Moghadas SM, Fitzpatrick MC, Sah P, et al. The implications
of silent transmission for the control of COVID-19 outbreaks. Proc
Natl Acad Sci U S A. 2020;117(30):17513-17515.10.1073/
pnas.2008373117, available at https://www.ncbi.nlm.nih.gov/pubmed/32632012.
\23\ Johansson MA, Quandelacy TM, Kada S, et al. SARS-CoV-2
Transmission from People Without COVID-19 Symptoms. Johansson MA, et
al. JAMA Netw Open. 2021 January4;4(1):e2035057. doi: 10.1001/
jamanetworkopen.2020.35057.
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Among adults, the risk for severe illness from COVID-19 increases
with age, with older adults at highest risk.\24\ Severe illness means
that persons with COVID-19 may require hospitalization, intensive care,
or a ventilator to help them breathe, and may die. People of any age
with certain underlying medical conditions (e.g., cancer, obesity,
serious heart conditions, diabetes, conditions that weaken the immune
system) are at increased risk for severe illness from COVID-19.\25\
---------------------------------------------------------------------------
\24\ CDC. COVID-19 Risks and Vaccine Information for Older
Adults https://www.cdc.gov/aging/covid19/covid19-older-adults.html.
\25\ People with Certain Medical Conditions https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
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B. Emergence of Variants of Concern
New variants of SARS-CoV-2 have emerged globally, several of which
have been identified as variants of concern, including the Delta
variant. Some variants are more transmissible and some may cause more
severe disease, which can lead to more hospitalizations, and deaths
among infected individuals.\26\ Furthermore, findings suggest some
variants may reduce levels of virus neutralization by antibodies
generated during previous infection or vaccination, resulting in
reduced effectiveness of treatments or vaccines, or increased
diagnostic detection failures.\27\ The emergence of variants that
substantially decreases the effectiveness of available vaccines against
severe or deadly disease is a primary public health concern. 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 remains not only a possibility, but a
current reality.
---------------------------------------------------------------------------
\26\ 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: https://dx.doi.org/10.15585/mmwr.mm7028e2
(describing a B.1.617.2 (Delta) Variant COVID-19 outbreak associated
with a gymnastics facility and finding that the Delta variant is
highly transmissible in indoor sports settings and households, which
might lead to increased incidence rates).
\27\ SARS-CoV-2 Variant Classifications and Definitions, Centers
for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern.
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As the virus spreads, it has new opportunities to change (mutate)
and may become more difficult to control. While it is known and
expected that viruses change through mutation leading to the emergence
of new variants, the existing Delta variant is particularly concerning
because it spreads more easily than previous variants of SARS-CoV-
2.\28\ The Delta variant has rapidly become the predominant strain in
the United States with more than 99% of U.S. cases attributed to it as
of October 16, 2021.\29\ Globally, 193 countries have reported cases of
the Delta variant as of October 19, 2021.\30\
---------------------------------------------------------------------------
\28\ 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.
\29\ https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
\30\ https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---19-october-2021.
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Of critical significance for this Amended Order, the Delta variant
has increased transmissibility, especially among persons who are not
fully vaccinated, and increases the risk of infection in fully
vaccinated individuals in the absence of other mitigation strategies,
such as mask wearing.\31\ For persons not fully vaccinated, Delta is a
formidable threat and the surge in cases since the summer of 2021 has
been fueled in part by low vaccination coverage in many U.S.
communities.\32\ Available evidence suggests all three vaccines
currently approved or authorized in the United States provide
significant protection.\33\ However, a small proportion of people who
are fully vaccinated may become infected, a risk that is increased with
the Delta variant; emerging evidence suggests that fully vaccinated
persons who do become infected with the Delta variant are at risk for
transmitting it to others.\34\ However, the vast majority of fully
vaccinated individuals continue to be protected from severe illness,
hospitalization, and death, even with the Delta variant.
---------------------------------------------------------------------------
\31\ Delta Variant: What We Know About the Science, https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html.
\32\ COVID Data Tracker Weekly Review, Interpretive Summary for
July 23, 2021, Centers for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/past-reports/07232021.html https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/past-reports/07232021.html.
\33\ Science Brief: COVID-19 Vaccines and Vaccination, Centers
for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. Other
vaccines, particularly the one manufactured by AstraZeneca, show
reduced efficacy against infection with certain variants but may
still protect against severe disease; at the time of the issuance of
this Order, the FDA has not authorized the AstraZeneca COVID-19
vaccine for use in the United States.
\34\ Delta Variant: What We Know About the Science, https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html.
---------------------------------------------------------------------------
C. Availability of Testing and Vaccines in the United States and
Globally
The potential for asymptomatic and pre-symptomatic transmission
makes testing an essential part of COVID-19 mitigation protocols. With
the additional testing capacity available through antigen tests,
infected persons can be identified more rapidly so they can be isolated
until they no longer pose a risk of spreading the virus and their
[[Page 61256]]
close contacts can be identified and quarantined.\35\
---------------------------------------------------------------------------
\35\ See COVID-19 Testing and Diagnostics Working Group (TDWG).
U.S. Department of Health and Human Services (HHS), https://www.hhs.gov/coronavirus/testing/testing-diagnostics-working-group/. (defining the role of the COVID-19 TDWG, which develops
testing-related guidance and provides targeted investments to expand
the available testing supply and maximize testing capacity).
---------------------------------------------------------------------------
COVID-19 vaccines are now widely available in the United States,
and vaccination is recommended for all people 12 years of age and
older. As of October 23, 2021, approximately 190.4 million people in
the United States (67.1% of the population 12 years or older) have been
fully vaccinated and over 219 million people in the United States
(77.6% of the population 12 years or older) have received at least one
dose.\36\ However, after a rapid increase in the proportion of the U.S.
population vaccinated against COVID-19 in the first months of 2021,
vaccinations administered in the United States have slowed,
particularly in those under the age of 65 years.\37\
---------------------------------------------------------------------------
\36\ https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
\37\ Ibid.
---------------------------------------------------------------------------
The combination of the substantial proportion of the population
that remains not fully vaccinated either through ineligibility (in the
case of children under 12 years) or by choice, and the extreme
transmissibility of the Delta variant resulted in sharp increases in
COVID-19 cases in the United States over the summer and early fall of
2021, primarily and disproportionately affecting persons not fully
vaccinated.
The availability of COVID-19 vaccines is also rising globally but
is still small when compared to the availability of vaccines in the
United States and a handful of other countries.\38\ Approximately 6.84
billion doses of COVID-19 vaccine have been administered globally.
However, vaccine supplies and testing capacity remain limited in many
low-income countries.39 40 Outbreaks linked to international
travel caused by unvaccinated and untested travelers have the potential
to increase the introduction, transmission, and spread of COVID-19
variants into the United States. Many other countries around the world
are making efforts to increase COVID-19 vaccination for their
populations, with some considering or adding proof of vaccination
requirements as a condition for entry.41 42 43
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\38\ See ``PAHO Director calls for fair and broad access to
COVID-19 vaccines for Latin America and the Caribbean,'' Pan
American Health Organization, https://www.paho.org/en/news/7-7-2021-paho-director-calls-fair-and-broad-access-covid-19-vaccines-latin-america-and (noting the discrepancies in vaccine availability
coverage among North, Central, and South American countries).
\39\ https://ourworldindata.org/covid-vaccinations.
\40\ https://ourworldindata.org/coronavirus-testing#testing-vs-gdp-per-capita.
\41\ See CNN Travel, New Zealand says foreign nationals must
have coronavirus vaccination to enter country from November, https://www.cnn.com/travel/article/new-zealand-travel-vaccination-covid-lockdown-ardern-intl/.
\42\ See CNN Canada issues COVID-19 vaccine mandate for
travelers 12 or older on trains and planes, https://www.cnn.com/travel/article/canada-trudeau-vaccine-mandate/.
\43\ https://www.forbes.com/sites/geoffwhitmore/2021/10/20/covid-19-vaccine-mandates-for-travel/?sh=23fc0cdd4edb.
---------------------------------------------------------------------------
CDC is aware of a rising number of SARS-CoV-2 infections in
vaccinated individuals; \44\ since vaccines are not 100% effective at
preventing infection, some people who are fully vaccinated may still
get COVID-19. While the vaccines currently approved or authorized by
the FDA are successful in preventing severe illness and death,
including from the highly transmissible Delta variant, infections and
even mild to moderate illness have been documented in a small
percentage of vaccinated persons. However, studies so far show that
vaccinated people are 5 times less likely to be infected and more than
10 times less likely to experience hospitalization or death due to
COVID-19 than people who are not fully vaccinated.\45\ The emergence of
the more transmissible Delta variant, as well as the potential
emergence of a variant of high consequence that could reduce the
effectiveness of treatments or vaccines, increases the urgency to
expand vaccination coverage.
---------------------------------------------------------------------------
\44\ COVID-19 Vaccine Breakthrough Case Investigation and
Reporting, https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html.
\45\ Scobie HM, Johnson AG, Suthar AB, et al. Monitoring
Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by
Vaccination Status--13 U.S. Jurisdictions, April 4-July 17, 2021.
MMWR Morb Mortal Wkly Rep. 2021;70(37):1284-1290. Published 2021 Sep
17. doi:10.15585/mmwr.mm7037e1.
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D. Justification for Continued Pre-Departure Testing
On December 25, 2020, in response to a new COVID-19 variant (now
referred to as the Alpha variant \46\) spreading in the United Kingdom
(UK), CDC issued an Order requiring proof of a negative viral test
result for all air passengers 2 years of age and older arriving from
the UK to the United States. A month later, cases, including those from
the Alpha variant, continued to increase significantly, and variants of
concern were identified in other countries, leading to CDC issuing an
Order on January 25, 2021 requiring all air passengers 2 years of age
and older traveling from any foreign country to show a negative pre-
departure COVID-19 test result or documentation of recovery from COVID-
19 in the previous 90 calendar days before boarding a flight to the
United States.
---------------------------------------------------------------------------
\46\ SARS-CoV-2 Variant Classifications and Definitions, https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html.
---------------------------------------------------------------------------
Testing for SARS-CoV-2 infection is a proactive, risk-based
approach that is not dependent on the infecting variant. This risk-
based testing approach has been addressed in CDC guidance and the
Runway to Recovery guidance jointly issued by the Departments of
Transportation, Homeland Security, and Health and Human Services.\47\
Most countries now use testing in some form to monitor risk and control
introduction and spread of SARS-CoV-2.\48\ With case counts and deaths
due to COVID-19, particularly the Delta variant, continuing to increase
around the globe, the high proportion of unvaccinated people in the
United States and around the world, and infected people with
asymptomatic or pre-symptomatic infections, the United States is taking
a multi-layered approach to combatting COVID-19, concurrently
preventing and slowing the continued introduction of cases and further
spread of the virus within U.S. communities. Vaccination is the most
important measure for reducing risk for SARS-CoV-2 transmission during
travel and in avoiding severe illness, hospitalization, and death;
however, infections in fully vaccinated people indicate that
vaccination is a necessary but not sufficient measure; testing of these
travelers is still necessary and thus required.
---------------------------------------------------------------------------
\47\ Runway to Recovery 1.1, December 21, 2020, available at
https://www.transportation.gov/briefing-room/runway-recovery-11.
\48\ https://ourworldindata.org/coronavirus-testing#testing-and-contact-tracing-policy.
---------------------------------------------------------------------------
Pre-departure testing does not eliminate all risk. However, when
pre-departure testing is combined with other measures such as self-
monitoring for symptoms of COVID-19, wearing masks, physical
distancing, and hand hygiene, it can make travel safer by reducing
spread on conveyances, in transportation hubs, and at destinations. CDC
recommends all international travelers get a viral test 3-5 days after
arrival at their U.S. destination, combined with self-monitoring.
Additionally, CDC recommends international travelers who are not fully
vaccinated stay home (or in a comparable location such as a hotel room)
and self-quarantine for a full 7
[[Page 61257]]
days after travel, or for 10 days if they do not get tested, to further
reduce the risk of translocating the virus into destination
communities.\49\
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\49\ International Travel During COVID-19 https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html.
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People who have recovered from COVID-19 can continue to shed
detectable but non-infectious SARS-CoV-2 RNA in upper respiratory
specimens for up to 3 months after illness onset.\50\ For this reason,
CDC does not recommend retesting of persons previously diagnosed with
COVID-19 within 3 months after the date of symptom onset (or the date
of first positive viral diagnostic test if their infection was
asymptomatic) for the initial SARS-CoV-2 infection, unless they have
symptoms of COVID-19. People who develop any symptoms of COVID-19
during this 90-day period following infection should not travel and
should consult a healthcare provider who can evaluate for other causes
of their symptoms and determine if testing is needed. This guidance may
be updated as additional information about people who have recovered
from COVID-19 becomes available.
---------------------------------------------------------------------------
\50\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
---------------------------------------------------------------------------
E. Pre-Departure Testing Requirements Based on Vaccination Status
Recent CDC modeling that incorporated the transmission
characteristics of the Delta variant shows evidence that for persons
not fully vaccinated, getting a viral test one day prior to departure
can reduce the risk of traveling with COVID-19 by 40%.\51\ When this
window is expanded to two days prior to departure, the reduction in
risk is 26%, and for three days prior to departure, the risk reduction
is only an estimated 14%. This modeling was based on real-world data on
virus transmissibility.52 53 54
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\51\ Public Health Guidance for Potential COVID-19 Exposure
Associated with Travel https://www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.html.
\52\ He, X., Lau, E.H.Y., Wu, P. et al. Temporal dynamics in
viral shedding and transmissibility of COVID-19. Nat Med 26, 672-675
(2020). https://doi.org/10.1038/s41591-020-0869-5.
\53\ W[ouml]lfel, R., Corman, V.M., Guggemos, W. et al.
Virological assessment of hospitalized patients with COVID-2019.
Nature 581, 465-469 (2020). https://doi.org/10.1038/s41586-020-2196-x.
\54\ Rachael Pung, Tze Minn Mak, Adam J Kucharski, Vernon J Lee,
Serial intervals in SARS-CoV-2 B.1.617.2 variant cases, The Lancet,
2021 ISSN 0140-6736, https://doi.org/10.1016/S0140-6736(21)01697-4.
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CDC's modeling also demonstrates that among travelers who are fully
vaccinated with a vaccine that has 60% effectiveness against SARS-CoV-2
infection, getting tested with a NAAT or antigen test 3 days before
departure can reduce risk that a person is infectious with COVID-19
during travel by 66%.\55\ Among fully vaccinated travelers, if this
testing window is decreased to two days, this risk is reduced by 71%,
and by 76% at one day before travel. Therefore, there is little public
health advantage to shortening the time period for testing for fully
vaccinated air passengers.\56\ The combination of vaccination and pre-
travel testing provides a greater level of protection than either
measure alone and is consistent with a layered strategy.
---------------------------------------------------------------------------
\55\ Public Health Guidance for Potential COVID-19 Exposure
Associated with Travel https://www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.html.
\56\ CDC recommends that fully vaccinated cruise ship passengers
receive a COVID-19 PCR or rapid antigen test no more than 2 days
before boarding or on embarkation day. See https://www.cdc.gov/quarantine/cruise/covid19-operations-manual-cso.html. While cruise
ships share similarities with other forms of travel, including air
travel, cruise ships represent a unique environment that facilitates
the spread of COVID-19 based on such factors as their larger size,
with larger cruises of more than 6,000 passengers, and ability to
bring an international cohort of passengers and crew together for
days or weeks at a time through frequent events such as group and
buffet dining, entertainment events, and excursions. Accordingly,
testing, and other public health recommendations for cruise ships
and air travel may differ.
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These models informed by analyses of real-world surveillance data
support the requirement of this Amended Order that passengers who are
not fully vaccinated get a specimen collected for a viral COVID-19 test
no more than 1 day before departure to the United States to minimize
the risk of transmission during travel and importing additional COVID-
19 cases and possible variants into the United States. The time window
between testing and travel is particularly relevant for those with
longer-duration travel, such as traveling long distances or on
connecting flights. However, decreasing the time window for testing
before departure from three days to one day provides minimal additional
public health benefit for fully vaccinated travelers. Therefore, fully
vaccinated air passengers will continue to be allowed to get a specimen
collected no more than 3 calendar days before their flight departure to
meet the requirements of this Amended Order.
F. Proof of Being Fully Vaccinated Against COVID-19
Documentation of COVID-19 vaccination status varies globally.
Governments, private industries, or medical providers may use a paper
or digital certification reflecting a person's COVID-19 vaccination
status that includes handwritten or typed text from an authorized
healthcare care provider, pharmacy, or other qualified entity. Some
governments and private industries have developed vaccination
credentials that are considered ``verifiable'' because they can be
electronically linked back to a person's vaccination data held by a
trusted source. The trusted source is able to then confirm the
authenticity and validity of the certificate and/or confirm that the
vaccination took place. An example of verifiable vaccination
credentials is a QR code image on paper or in digital format, such as
on a mobile phone, that links to the person's verified vaccination
data.
Considering the variability of vaccine credentials globally, this
Amended Order provides the airline or aircraft operator the discretion
to accept different forms of vaccine credentials, whether paper,
digital, or verifiable, for passengers who submit a Qualifying Test for
Fully Vaccinated accompanied by Proof of Being Fully Vaccinated Against
COVID-19. While this Amended Order may be enforced through criminal
penalties under 18 U.S.C. 3559, 3571; 42 U.S.C. 271; and 42 CFR 71.2,
CDC does not intend to rely on this enforcement mechanism for airlines
or aircraft operators who accept paper or digital documentation of
vaccination (i.e., paper or digital vaccination records, verifiable
vaccination credential) from a passenger in good faith and use best
efforts to fulfill the requirements of this Amended Order.
G. Statement of Good Cause Under the Administrative Procedure Act
(``APA'')
COVID-19 cases, hospitalizations, and deaths rapidly increased over
the summer and early fall of 2021, especially in areas with higher
levels of community transmission and lower vaccination coverage.\57\
Pediatric cases and hospitalizations also increased over the same time
period.58 59 While cases are currently decreasing in the
United
[[Page 61258]]
States, during the entirety of this pandemic, cases have tended to
surge in waves, including after high-volume travel periods, with 4
waves as of October 2021.\18\ Therefore, additional surges of cases and
deaths are very possible.
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\57\ Scobie HM, Johnson AG, Suthar AB, Severson R, Alden NB,
Balter S, Bertolino D, Blythe D, Brady S, Cadwell B, Cheng I.
Monitoring incidence of covid-19 cases, hospitalizations, and
deaths, by vaccination status--13 US jurisdictions, April 4-July 17,
2021. Morbidity and Mortality Weekly Report. 2021 Sep
17;70(37):1284.
\58\ Delahoy MJ, Ujamaa D, Whitaker M, O'Halloran A, Anglin O,
Burns E, Cummings C, Holstein R, Kambhampati AK, Milucky J, Patel K.
Hospitalizations associated with COVID-19 among children and
adolescents--COVID-NET, 14 states, March 1, 2020-August 14, 2021.
Morbidity and Mortality Weekly Report. 2021 Sep 10;70(36):1255.
\59\ Siegel DA, Reses HE, Cool AJ et al. Trends in COVID-19
cases, emergency department visits, and hospital admissions among
children and adolescents aged 0-17 years--United States, August
2020-August 2021. Morbidity and Mortality Weekly Report. 2021 Sep
10;70(36):1249.
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To reduce introduction and spread of future SARS-CoV-2 variants
into the United States at a time when global air travel is increasing,
CDC must take quick and targeted action to curtail the introduction of
other new variants into the United States.
This Amended Order is not a rule within the meaning of the
Administrative Procedure Act (``APA'') but rather is an emergency
action taken under the existing authority of 42 U.S.C. 264(a) and 42
CFR 71.20 and 71.31(b), which were promulgated in accordance with the
APA after full notice and comment rulemaking and a delay in effective
date. In the event that this Amended Order qualifies as a new 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 comment and a delay in effective date. See 5 U.S.C.
553(b)(B), (d)(3).
Considering the rapid and unpredictable developments in the public
health emergency caused by COVID-19, 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 Amended
Order. Further delay could increase risk of transmission and
importation of additional undetected cases of SARS-CoV-2 Delta variant
or other emerging variants through not fully vaccinated passengers who
become infectious during the 3-day window currently allowed for
predeparture testing.
Similarly, the Office of Information and Regulatory Affairs has
determined that if this Amended Order were a rule, it would be a major
rule under Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (the Congressional Review Act), 5 U.S.C. 804(2),
but there would not be a delay in its effective date as the agency has
determined that there would be good cause to make the requirements
herein effective immediately under the APA, 5 U.S.C. 808(2).
This Amended Order is also an economically significant regulatory
action under Executive Order 12866 and has therefore been reviewed by
the Office of Information and Regulatory Affairs of the Office of
Management and Budget.
If any provision of this Amended 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.
Pursuant to 5 U.S.C. 553(b)(B), and for the reasons stated above, I
hereby conclude that notice-and-comment rulemaking would defeat the
purpose of the Amended Order and endanger the public health, and is,
therefore, impracticable and contrary to the public interest. For the
same reasons, I have determined, consistent with 5 U.S.C. 553(d)(3),
that there is good cause to make this Amended Order effective
immediately upon filing at the Office of the Federal Register.
Action
For the reasons outlined above, I hereby determine that passengers
covered by this Amended Order are at risk of transmitting SARS-CoV-2
virus, including virus variants, and that requiring such passengers to
demonstrate either negative COVID-19 test results or recovery from
COVID-19 after previous SARS-CoV-2 infection is needed as a public
health measure to protect the health of fellow travelers and U.S.
communities. These actions are necessary to reduce the risk of
transmission of new SARS-CoV-2 virus, including virus variants, and to
protect the health of fellow travelers and U.S. communities.
This Amended Order shall remain effective until either the
expiration of the Secretary of HHS' declaration that COVID-19
constitutes a public health emergency, or I determine that based on
specific public health or other considerations that continuation of
this Order is no longer necessary to prevent the further introduction,
transmission, and spread of COVID-19 into the United States, whichever
occurs first. Upon determining that continuation of this Order is no
longer necessary to prevent the further introduction, transmission, and
spread of COVID-19 into the United States, I will publish a notice in
the Federal Register terminating this Order. I retain the authority to
modify or terminate the Order, or its implementation, at any time as
needed to protect public health.
1. Requirements for Airlines & Other Aircraft Operators
Any airline or other aircraft operator with passengers arriving
into the United States from a foreign country, shall:
A. Confirm that every passenger--2 years or older--onboard the
aircraft has paper or digital documentation reflecting a Qualifying
Test for Fully Vaccinated, a Qualifying Test for Not Fully Vaccinated,
or Documentation of Recovery.
(1) Requirements for a Qualifying Test for Fully Vaccinated
include:
a. Documentation of a negative SARS-CoV-2 viral test result from a
specimen collected no more than 3 calendar days preceding the
passenger's flight to the United States. The negative SARS-CoV-2 viral
test result should include:
i. Personal identifiers (e.g., name and date of birth) on the
negative test result that match the personal identifiers on the
passenger's passport or other travel documents;
ii. a specimen collection date indicating that the specimen was
collected no more than 3 days before the flight's departure (or first
flight in a series of connections booked on the same itinerary); \60\
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\60\ Passengers traveling on a series of connections booked on
the same itinerary also have the option of obtaining the required
negative test result en route to the United States if testing within
the required time frame is not available at their point of origin.
---------------------------------------------------------------------------
iii. type of viral test indicating it is a NAAT or antigen test;
iv. a test result that states ``NEGATIVE,'' ``SARS-CoV-2 RNA NOT
DETECTED,'' ``SARS-CoV-2 ANTIGEN NOT DETECTED,'' or ``COVID-19 NOT
DETECTED,'' or other indication that SARS-CoV-2 was not detected in the
individual's specimen. A test marked ``invalid'' is not acceptable; and
v. information about the entity issuing the result (e.g.,
laboratory, healthcare entity, or telehealth service), such as the name
and contact information; and
b. Proof of Being Fully Vaccinated Against COVID-19 against COVID-
19 as defined in this Amended Order, that includes personal identifiers
(e.g., name and date of birth) that match the personal identifiers on
the passenger's passport or other travel documents.
(2) Requirements for a Qualifying Test for Not Fully Vaccinated
include:
a. Documentation of a negative SARS-CoV-2 viral test result from a
specimen collected no more than 1 day preceding the passenger's flight
to the United States. The negative SARS-CoV-2 viral test result should
include:
i. Personal identifiers (e.g., name and date of birth) on the
negative test result that match the personal identifiers on the
passenger's passport or other travel documents;
ii. specimen collection date indicating that the specimen was
collected no more than 1 day before the flight's departure (or first
flight in a series of
[[Page 61259]]
connections booked on the same itinerary); \61\
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\61\ Ibid.
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iii. type of viral test indicating it is a NAAT or antigen test;
iv. a test result that states ``NEGATIVE,'' ``SARS-CoV-2 RNA NOT
DETECTED,'' ``SARS-CoV-2 ANTIGEN NOT DETECTED,'' or ``COVID-19 NOT
DETECTED,'' or other indication that SARS-CoV-2 was not detected in the
individual's specimen. A test marked ``invalid'' is not acceptable; and
v. information about the entity issuing the result (e.g.,
laboratory, healthcare entity, or telehealth service), such as the name
and contact information.
(3) Requirements for Documentation of Recovery include:
a. Documentation of a positive SARS-CoV-2 viral test result from a
specimen collected no more than three months (90 calendar days)
preceding the passenger's flight to the United States, or at such other
intervals as specified in CDC guidance. \62\ The positive SARS-CoV-2
viral test result should include:
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\62\ Interim Guidance on Ending Isolation and Precautions for
Adults with COVID-19 https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
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i. Personal identifiers (e.g., name and date of birth) on the
positive test result match the personal identifiers on the passenger's
passport or other travel documents;
ii. a specimen collection date indicating that the specimen was
collected no more than 90 calendar days before the flight's departure;
iii. information that the test performed was a viral test
indicating it is a NAAT or antigen test;
iv. a test result that states ``POSITIVE,'' ``SARS-CoV-2 RNA
DETECTED,'' ``SARS-CoV-2 ANTIGEN DETECTED,'' or ``COVID-19 DETECTED,''
or other indication that SARS-CoV-2 was detected in the individual's
specimen. A test marked ``invalid'' is not acceptable; and
v. information about the entity issuing the result (e.g.,
laboratory, healthcare entity, or telehealth service), such as the name
and contact information.
b. A signed letter from a licensed healthcare provider or a public
health official stating that the passenger has been cleared for
travel.63 64 The letter must have personal identifiers
(e.g., name and date of birth) that match the personal identifiers on
the passenger's passport or other travel documents. The letter must be
signed and dated on official letterhead that contains the name,
address, and phone number of the healthcare provider or public health
official who signed the letter.
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\63\ Healthcare providers and public health officials should
follow CDC guidance in clearing patients for travel to the United
States. Applicable guidance is available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html.
\64\ A letter from a healthcare provider or a public health
official that clears the person to end isolation, e.g., to return to
work or school, can also be used to show that the person has been
cleared to travel, even if travel is not specifically mentioned in
the letter.
---------------------------------------------------------------------------
B. Confirm that each passenger has attested to having received a
negative result for a Qualifying Test for Fully Vaccinated plus being
fully vaccinated, a negative result for a Qualifying Test for Not Fully
Vaccinated, or having tested positive for SARS-CoV-2 on a specimen
collected no more than 90 calendar days before the flight and been
cleared to travel. Airlines or other aircraft operators must retain a
copy of each passenger attestation for 2 years. The attestation is
attached to this order as Attachment A.
C. Not board any passenger without confirming the documentation as
set forth in A and B.
Any airline or other aircraft operator that fails to comply with
section 1, ``Requirements for Airlines & Other Aircraft Operators,''
may be subject to criminal penalties under, inter alia, 42 U.S.C. 271
and 42 CFR 71.2, in conjunction with 18 U.S.C. 3559 and 3571. However,
CDC does not intend to rely on this enforcement mechanism for airlines
or aircraft operators who accept paper or digital documentation of
vaccination (i.e., paper or digital vaccination records, or verifiable
vaccination credential) from a passenger in good faith and use best
efforts to fulfill the requirements of this Amended Order.
2. Requirements for Aircraft Passengers
Any aircraft passenger 65 66 departing from any foreign
country with a destination in the United States shall--
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\65\ A parent or other authorized individual may present the
required documentation on behalf of a passenger 2-17 years of age.
An authorized individual may act on behalf of any passenger who is
unable to act on their own behalf (e.g., by reason of age, or
physical or mental impairment).
\66\ Children between the ages of 2 and 17 who are not fully
vaccinated may board a flight to the United States with a negative
pre-departure COVID-19 viral test conducted on a specimen collected
no more than 3 calendar days before departure (i.e., Qualifying Test
for Fully Vaccinated) if traveling accompanied by fully vaccinated
parents or guardians. If traveling unaccompanied or if one or more
of the parents or guardians accompanying the child is not fully
vaccinated, the child must present a negative pre-departure COVID-19
viral test on a specimen collected no more than 1 day before
departure (i.e., a Qualifying Test for Not Fully Vaccinated).
---------------------------------------------------------------------------
A. Present paper or digital documentation reflecting one of the
following:
(1) A negative Qualifying Test for Fully Vaccinated that has a
specimen collection date indicating that the specimen was collected no
more than 3 calendar days before the flight's departure (or first
flight in a series of connections booked on the same itinerary) \67\
plus Proof of Being Fully Vaccinated Against COVID-19 against COVID-19;
---------------------------------------------------------------------------
\67\ Passengers traveling on a series of connections booked on
the same itinerary also have the option of obtaining the required
negative test result en route to the United States if testing within
the required time frame is not available at their point of origin.
---------------------------------------------------------------------------
(2) A negative Qualifying Test for Not Fully Vaccinated that has a
specimen collection date indicating that the specimen was collected no
more than 1 day before the flight's departure (or first flight in a
series of connections booked on the same itinerary); \68\ or
---------------------------------------------------------------------------
\68\ Ibid.
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(3) Documentation of Recovery from COVID-19 that includes a
positive SARS-CoV-2 viral test result conducted on a specimen collected
no more than 90 calendar days before the flight and a letter from a
licensed healthcare provider or public health official stating that the
passenger has been cleared for travel.69 70
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\69\ A letter from a healthcare provider or a public health
official that clears the person to end isolation, e.g., to return to
work or school, can also be used to show that the person has been
cleared to travel, even if travel is not specifically mentioned in
the letter.
\70\ Healthcare providers and public health officials should
follow CDC guidance in clearing patients for travel to the United
States. Applicable guidance is available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html.
---------------------------------------------------------------------------
B. Provide the attestation to the airline or other aircraft
operator, of one of the following:
(1) having received a negative result for the Qualifying Test for
Vaccinated and being fully vaccinated against COVID-19;
(2) having received a negative result for the Qualifying Test for
Not Fully Vaccinated; or
(3) having tested positive for SARS-CoV-2 on a specimen collected
no more than 90 calendar days before the flight and been cleared to
travel.
The attestation is attached to this order as Attachment A. Unless
otherwise permitted by law, a parent or other authorized individual may
present the required documentation on behalf of a passenger 2-17 years
of age. An authorized individual may act on behalf of any passenger who
is unable to act on their own behalf (e.g., by reason of age, or
physical or mental impairment).
C. Retain a copy of the applicable documentation listed in part A
of this section and produce such
[[Page 61260]]
documentation upon request to any U.S. government official or a
cooperating state or local public health authority after arrival in the
United States.
Any passenger who fails to comply with the requirements of section
2, ``Requirements for Aircraft Passengers,'' may be subject to criminal
penalties under, inter alia, 42 U.S.C. 271 and 42 CFR 71.2, in
conjunction with 18 U.S.C. 3559 and 3571. Willfully giving false or
misleading information to the government may result in criminal
penalties under, inter alia, 18 U.S.C. 1001.
This Amended Order shall be enforceable through the provisions of
18 U.S.C. 3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR 71.2.
As the pandemic continues to rapidly evolve and more scientific
data becomes available regarding additional variants of concern and/or
the effectiveness of COVID-19 vaccines, CDC may exercise its
enforcement discretion to broaden the scope of accepted vaccines or
combinations of accepted vaccines to allow passengers and airline and
aircraft operators greater flexibility regarding the requirements of
this Amended Order or to align with current CDC guidance. Such
exercises of enforcement discretion will be announced on CDC's website
and the Amended Order will be further amended as soon as practicable
through an updated publication in the Federal Register.
Effective Date
This Amended Order shall enter into effect at 12:01am EST (5:01am
GMT) on November 8, 2021, and will remain in effect unless modified or
rescinded based on specific public health or other considerations, or
until the Secretary of Health and Human Services rescinds the
determination under section 319 of the Public Health Service Act (42
U.S.C. 247d) that a public health emergency exists with respect to
COVID-19.
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[[Page 61276]]
Sherri Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-24388 Filed 11-3-21; 4:15 pm]
BILLING CODE 4163-18-C