[Federal Register Volume 86, Number 232 (Tuesday, December 7, 2021)]
[Notices]
[Pages 69256-69284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Requirements 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 amended Agency 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 a 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. This Amended Order was signed by the CDC Director on December 
2, 2021, and supersedes the previous Order signed by the CDC Director 
on October 25, 2021.

DATES: This Amended Order will become effective at 12:01 a.m. on 
December 6, 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. Email: 
[email protected]. Telephone: 1-800-232-4636.

SUPPLEMENTARY INFORMATION: This Amended Order updates COVID-19 testing 
requirements for air passengers 2 years or older boarding a flight to 
the United States.
    This Amended Order prohibits the boarding of any passenger 2 years 
or older on any airline or aircraft destined to the United States from 
a foreign country unless the passenger presents paper or digital 
documentation of one of the following requirements:
    (i) A negative pre-departure viral test result for SARS-CoV-2 
conducted on a specimen collected no more than 1 calendar day before 
the flight's departure from a foreign country (Qualifying Test)

Or

    (ii) Documentation of having recovered from COVID-19 in the past 90 
days in the form of both of the following (Documentation of Recovery):
     A positive viral test result for SARS-CoV-2 conducted on a 
specimen

[[Page 69257]]

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.
    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 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)

REQUIREMENTS 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 and 71.31(b) and as set forth in greater 
detail below, this Notice and Amended Order prohibits the boarding of 
any passenger--2 years of age or older--on any aircraft destined to the 
United States \1\ from a foreign country unless the passenger: \2\
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    \1\ This includes any flight regardless of whether the United 
States is the final destination or a connection to another country.
    \2\ A parent or other authorized individual may present the 
required documentation on behalf of a passenger 2-17 years of age. 
Children under the age of 2 years of age are not subject to the 
requirements of this Amended Order. 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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    Presents paper or digital documentation of one of the following 
requirements:
    (iii) A negative pre-departure viral test result for SARS-CoV-2 
conducted on a specimen collected no more than 1 calendar day before 
the flight's departure from a foreign country (Qualifying Test)

Or

    (iv) Documentation of having recovered from COVID-19 in the past 90 
days in the form of both of the following (Documentation of Recovery):
     A positive viral test result for SARS-CoV-2 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.
    Each passenger must retain paper or digital documentation presented 
to the airline or other aircraft operator reflecting one of the 
following:
     A negative result for the Qualifying Test; or
     Documentation of Recovery from COVID-19.
    Upon request, a passenger, or the passenger's authorized 
representative, must also produce such documentation 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 constitutes a controlled free 
pratique to any airline or other aircraft operator with an aircraft 
arriving into the United States.\3\ 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 within the United States:
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    \3\ On October 25, 2021, the President issued a Proclamation, 
titled, ``Advancing the Safe Resumption of Global Travel During the 
COVID-19 Pandemic.'' On November 26, 2021, the President issued a 
Proclamation, titled, ``A Proclamation on Suspension of Entry as 
Immigrants and Nonimmigrants of Certain Additional Persons Who Pose 
a Risk of Transmitting Coronavirus Disease 2019.'' These 
Proclamations were issued pursuant to Sections1182(f) and 1185(a)(1) 
of Title 8, and Section 301 of Title 3, United States Code. This 
amended CDC Order complements and advances these Proclamations.
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     Airline or other aircraft operator must confirm that every 
passenger onboard the aircraft has presented a negative result for a 
Qualifying Test or Documentation of Recovery.
     Airline or other aircraft operator must verify that every 
passenger onboard the aircraft has attested to receiving a negative 
result for the Qualifying Test 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.
    This Notice and Amended Order does not alter the obligation of 
persons to comply with the applicable requirements of other CDC Orders, 
including:
     Requirement for Persons to Wear Masks While on Conveyances 
and at Transportation Hubs (published at 86 FR 8025, February 3, 2021) 
(as may be further amended);
     Amended Order Implementing Presidential Proclamation on 
Advancing the Safe Resumption of Global Travel During the COVID-19 
Pandemic (published at 86 FR 61224, November 5, 2021); and
     Other CDC Orders or CDC Directives that may be published 
relating to preventing the introduction, transmission, and spread of 
COVID-19 into and throughout the United States.
    This Notice and Amended Order supersede the previous Order signed 
by the CDC Director on October 25, 2021. This Order shall enter into 
effect for flights departing at or after 12:01 a.m. EST (5:01 a.m. GMT) 
on December 06, 2021.

Statement of Intent

    This Amended 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 the Omicron virus variant and other 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

    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.\4\ Such attestation may be completed in paper or digital 
form. The attestation

[[Page 69258]]

is a statement, writing, entry, or other representation under 18 U.S.C. 
1001.\5\
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    \4\ CDC has provided a combined passenger disclosure and 
attestation that fulfills the requirements of CDC Orders: 
Requirements for Negative Pre-departure COVID-19 Test Result or 
Documentation of Recovery from COVID-19 and Testing for All Airline 
or Other Aircraft Passengers Arriving into the United States from 
Any Foreign Country and Order Implementing Presidential Proclamation 
on Advancing the Safe Resumption of Global Travel During the COVID-
19 Pandemic.
    \5\ 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 
having recovered from COVID-19 in the form of a positive SARS-CoV-2 
viral test result 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).\6\ \7\ The viral test must have been 
conducted on a specimen collected no more than 90 calendar days before 
the departure of the flight, or at such other intervals as specified in 
CDC guidance.
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    \6\ 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.
    \7\ 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.
    Qualifying Test 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.
    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) cleared, approved, or issued an emergency use authorization (EUA) 
by the U.S. Food and Drug Administration, or granted marketing 
authorization by the relevant national authority, for the detection of 
SARS-CoV-2, performed in accordance with the approval/clearance/EUA/
marketing authorization.

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).\8\
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    \8\ 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.\9\
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    \9\ 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.\10\
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    \10\ 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.

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 December 
02, 2021, there have been over 262,000,000 million cases of COVID-19 
globally, resulting in over 5,200,000 deaths.\11\ In the United States, 
more than 48,000,000 cases have been identified, and over 775,000 
deaths attributed to the disease.
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    \11\ 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.\12\ \13\ 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.\14\ \15\
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    \12\ 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.
    \13\ 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.
    \14\ 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.
    \15\ 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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[[Page 69259]]

    Among adults, the risk for severe illness from COVID-19 increases 
with age, with older adults at highest risk.\16\ Severe illness means 
that persons with COVID-19 may require hospitalization, intensive care, 
or a ventilator to help them breathe. 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.\17\
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    \16\ CDC. COVID-19 Risks and Vaccine Information for Older 
Adults https://www.cdc.gov/aging/covid19/covid19-older-adults.html.
    \17\ 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: Omicron

    New variants of SARS-CoV-2 have emerged globally, several of which 
have been broadly classified as ``variants of concern.'' Some variants 
are more transmissible, even among those who are vaccinated, and some 
may cause more severe disease, which can lead to more hospitalizations 
and deaths among infected individuals.\18\ Furthermore, recent findings 
suggest that antibodies generated during previous infection or 
vaccination may have a reduced ability to neutralize some variants, 
resulting in reduced effectiveness of treatments or vaccines, or 
increased diagnostic detection failures.\19\ The emergence of variants 
that substantially decrease the effectiveness of available vaccines 
against severe or deadly disease is a primary public health concern.
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    \18\ 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).
    \19\ 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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    On November 24, 2021, the Republic of South Africa informed the 
World Health Organization (WHO) of a new variant of SARS-CoV-2, the 
virus that causes COVID-19, that was detected in that country. On 
November 26, 2021, WHO designated the variant B.1.1.529 as a variant of 
concern and named it Omicron.\20\ This decision was based on the 
evidence presented to the Technical Advisory Group on SARS-CoV-2 Virus 
Evolution (TAG-VE) which is a group of independent experts charged with 
assessing the evolution of SARS-CoV-2 and examining if specific 
mutations and combinations of mutations may alter how the virus spreads 
and whether it may cause more severe illness. The evidence presented to 
the TAG-VE noted that Omicron has several mutations that may have an 
impact on how easily it spreads or the severity of illness it 
causes.\21\
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    \20\ https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-concern.
    \21\ https://www.who.int/news/item/28-11-2021-update-on-omicron.
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    Currently, there are no data available to assess the ability of 
sera from vaccinated persons or those with previous SARS-CoV-2 
infection to neutralize the Omicron variant. The spike protein is the 
primary target of vaccine-induced immunity. The Omicron variant 
contains more changes in the spike protein than have been observed in 
other variants. Based on the number of substitutions, the location of 
these substitutions, and data from other variants with similar spike 
protein substitutions, significant reductions in neutralizing activity 
of sera from vaccinated or previously infected individuals, which may 
indicate reduced protection from infection, are anticipated.\22\
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    \22\ Science Brief: Omicron (B.1.1.529) Variant, Centers for 
Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-omicron-variant.html.
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    At the present time, WHO and CDC are coordinating with many 
researchers around the world to better understand the Omicron variant. 
Studies include assessments of transmissibility, severity of infection 
(including symptoms), performance of vaccines and diagnostic tests, and 
effectiveness of treatments. CDC and other federal agencies are working 
closely with international public health agencies to monitor the 
situation closely and are taking steps to enhance surveillance for and 
response to the Omicron variant within the United States. Considering 
these ongoing studies into the potential danger to public health posed 
by this newly identified variant, CDC has determined that proactive 
measures must be implemented now to protect the U.S. public health from 
the importation, transmission and spread of the emergent Omicron 
variant into the United States.

C. Requirement for Pre-Departure Testing Regardless of Vaccination 
Status

    On November 26, 2021, the President issued a Proclamation 
suspending the entry into the United States, of immigrants or 
nonimmigrants, of noncitizens who were physically present within 
certain Southern African countries during the 14-day period preceding 
their entry or attempted entry into the United States.\23\ This 
Proclamation was issued under the authority of sections 212(f) and 
215(a) of the Immigration and Nationality Act, as codified at sections 
1182(f) and 1185(a) of title 8, United States Code (U.S.C.), and 3 
U.S.C. 301 based on a determination that entry of certain noncitizens 
covered by the Proclamation would be detrimental to the interests of 
the United States. The Proclamation directs the Secretary of State, the 
Secretary of Transportation, and the Secretary of Homeland Security to 
endeavor to ensure that any noncitizen subject to the Proclamation does 
not board an aircraft traveling to the United States, to the extent 
permitted by law. The Proclamation also states that any individuals 
exempt from the suspension may nevertheless be subject to an entry 
suspension, limitation, or restriction under Proclamation 10294 of 
October 25, 2021.
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    \23\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/11/26/a-proclamation-on-suspension-of-entry-as-immigrants-and-nonimmigrants-of-certain-additional-persons-who-pose-a-risk-of-transmitting-coronavirus-disease-2019/.
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    As the virus that causes COVID-19 spreads, it has new opportunities 
to change (mutate) and become more difficult to control. While it is 
known and expected that viruses change through mutation leading to the 
emergence of new variants, the emergent Omicron variant is particularly 
concerning and of critical significance for this Amended Order. CDC has 
determined that given the rapid spread of the Omicron variant, 
including to countries and regions outside of those originally 
identified in the November 26 Proclamation, requiring a SARS-CoV-2 test 
no more than 1 calendar day before the flight's departure from a 
foreign country as specified in this Notice and Amended Order, and 
applicable to all passengers regardless of vaccination status or 
country of origin (except passengers who present valid Documentation of 
Recovery), is necessary to protect the public health of the United 
States.
    In response to this new variant, the United States Government, 
including CDC, reexamined its policies on international travel and 
concluded the proactive 1 calendar day testing measure is necessary to 
protect the public health and should remain in place until more 
information becomes available that may alter or improve the public 
health outlook. This Amended Order requires that all passengers,

[[Page 69260]]

regardless of vaccination status or country of origin, except 
passengers who present a valid Documentation of Recovery, provide 
documentation of a negative SARS-CoV-2 viral test result from a 
specimen collected no more than 1 calendar day preceding the departure 
of the passenger's originating flight to the United States. While CDC's 
previous Amended Order \24\ indicated that ``decreasing the time window 
for testing before departure from three days to one day provides 
minimal additional public health benefit for fully vaccinated 
travelers,'' this statement did not account for the Omicron variant, 
which had not yet been identified.
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    \24\ https://www.federalregister.gov/documents/2021/11/05/2021-24388/requirement-for-negative-pre-departure-covid-19-test-result-or-documentation-of-recovery-from.
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    At this time, it is unknown what level of protection current 
vaccines will provide against this newly emergent mutated variant. To 
best protect the health of the United States, unless and until CDC can 
confirm that current approved and authorized vaccines provide adequate 
protection against the Omicron variant, all passengers--including those 
who are fully vaccinated, but excluding passengers who present a valid 
Documentation of Recovery--must obtain a viral test on a specimen 
collected no more than 1 calendar day before their flight's departure 
to meet the requirements of this Amended Order. The one-day time 
window, a reduction from the previous 3-day window for fully vaccinated 
passengers, will provide less opportunity to develop infection with the 
Omicron variant prior to arrival into the United States.
    Testing for SARS-CoV-2 infection is a proactive, risk-based 
approach that is not dependent on the infecting variant, nor on 
vaccination status of the individual. 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.\25\ Most countries now use testing in 
some form to monitor risk and control introduction and spread of SARS-
CoV-2.\26\ With case counts and deaths due to COVID-19 continuing to 
increase around the globe and the emergence of the new and concerning 
Omicron variant, the United States is taking a multi-layered proactive 
approach to combating COVID-19, concurrently preventing and slowing the 
continued introduction of cases and further spread of the virus within 
U.S. communities. CDC acknowledges that pre-departure testing does not 
eliminate all risk.
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    \25\ Runway to Recovery 1.1, December 21, 2020, available at 
https://www.transportation.gov/briefing-room/runway-recovery-11.
    \26\ https://ourworldindata.org/coronavirus-testing#testing-and-contact-tracing-policy.
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D. Statement of Good Cause Under the Administrative Procedure Act 
(``APA'')

    To reduce introduction and spread of current and 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 help curtail the 
introduction and spread of the Omicron variant into the United States. 
As of December 2, 2021, WHO has indicated that 23 countries have 
reported cases of the Omicron variant, many of which were associated 
with international travelers.
    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, including the recently identified 
emergent Omicron variant, 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 Omicron variant or other emerging variants through 
passengers.
    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 the emergent Omicron variant and other virus variants. 
Accordingly, requiring passengers to demonstrate pre-departure either a 
negative COVID-19 test result or recovery from COVID-19 after previous 
SARS-CoV-2 infection in the past 90 days is necessary to reduce the 
risk of transmission of the SARS-CoV-2 virus, including the Omicron 
variant and other virus variants, and to protect the health of fellow 
passengers, aircraft crew, 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.

[[Page 69261]]

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 or Documentation of Recovery.
    (1) Requirements for a Qualifying Test include:
    a. Documentation of a negative SARS-CoV-2 viral test result from a 
specimen collected no more than 1 calendar day preceding the 
passenger's flight to the United States. The negative SARS-CoV-2 viral 
test result must 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 1 calendar day before the flight's departure (or 
first flight in a series of connections booked on the same itinerary);
    iii. the 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.
    (2) Requirements for Documentation of Recovery include:
    a. Documentation of a positive SARS-CoV-2 viral test result from a 
specimen collected no more than 90 calendar days preceding the 
passenger's scheduled flight to the United States.\27\ The positive 
SARS-CoV-2 viral test result must include:
---------------------------------------------------------------------------

    \27\ 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.28 29 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.
---------------------------------------------------------------------------

    \28\ 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.
    \29\ 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 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 section 1.A and 1.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.
2. Requirements for Aircraft Passengers
    Any aircraft passenger \30\ departing from any foreign country with 
a destination in the United States shall--
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    \30\ 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).
---------------------------------------------------------------------------

    A. Present paper or digital documentation reflecting one of the 
following:
    (1) A negative Qualifying Test that has a specimen collection date 
indicating that the specimen was collected no more than 1 calendar day 
before the flight's departure (or first flight in a series of 
connections booked on the same itinerary); or
    (2) 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.31 32
---------------------------------------------------------------------------

    \31\ 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.
    \32\ 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:
    (1) Having received a negative result for the Qualifying Test; or
    (2) 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 documentation upon request to any U.S. 
government official or a cooperating state or local public health 
authority after arrival into 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.

[[Page 69262]]

    As the pandemic continues to rapidly evolve and more scientific 
data becomes available regarding the emergent Omicron variant and/or 
the effectiveness of COVID-19 vaccines related to currently circulating 
variants, CDC may exercise its enforcement discretion to adjust the 
scope of accepted pre-departure testing requirements 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 for flights departing at 
or after 12:01 a.m. EST (5:01 a.m. GMT) on December 6, 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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[[Page 69284]]



Authority

    The authority for this Amended Order is Section 361 of the Public 
Health Service Act (42 U.S.C. 264) and 42 CFR 71.20 & 71.31(b).

Sherri Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-26603 Filed 12-3-21; 4:15 pm]
BILLING CODE 4163-18-C