[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]


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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.

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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:
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    \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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    (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).
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    \4\ https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html.
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    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:
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    \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.
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     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\
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    \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
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    \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
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    \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.
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    \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.
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    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.
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    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\
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    \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.
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     Airlines or other aircraft operators transporting 
passengers with COVID-19 pursuant to CDC authorization and in 
accordance with CDC guidance.\15\
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    \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.
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     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\
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    \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.
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    \17\ https://covid19.who.int/.
    \18\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
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    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\
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    \19\ https://covid19.who.int/.
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    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\
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    \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.
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    \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: http://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\
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    \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.
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    \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.
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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

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close contacts can be identified and quarantined.\35\
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    \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/index.html. (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).
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    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\
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    \36\ https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
    \37\ Ibid.
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    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
---------------------------------------------------------------------------

    \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/index.html.
    \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/index.html.
    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \49\ International Travel During COVID-19 https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html.
---------------------------------------------------------------------------

    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
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \61\ Ibid.
---------------------------------------------------------------------------

    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:
---------------------------------------------------------------------------

    \62\ Interim Guidance on Ending Isolation and Precautions for 
Adults with COVID-19 https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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--
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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
---------------------------------------------------------------------------

    \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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Sherri Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-24388 Filed 11-3-21; 4:15 pm]
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