[Federal Register Volume 86, Number 17 (Thursday, January 28, 2021)]
[Notices]
[Pages 7387-7391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01977]


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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 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 
Agency 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 Order was signed by the CDC Director on January 25, 2021 
and supersedes the previous Order signed by the CDC Director on January 
12, 2021.

DATES: This Order was effective January 26, 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].

SUPPLEMENTARY INFORMATION: This Order prohibits the introduction into 
the United States of any aircraft passenger departing from any foreign 
country unless the passenger: (1) Has a negative pre-departure test 
result for SARS-CoV-2, the virus that causes COVID-19 (Qualifying 
Test); or (2) written or electronic documentation of recovery from 
COVID-19 after previous SARS-CoV-2 infection in the form of a positive 
viral test result and a letter from a licensed health care provider or 
public health official stating that the passenger has been cleared for 
travel (Documentation of Recovery).
    This Order supersedes the previous Order signed by the CDC Director 
on January 12, 2021. This Order further clarifies the exemption 
categories for federal law enforcement and U.S. Department of Defense 
(DOD) personnel observing DOD precautions to prevent the transmission 
of COVID-19 during travel. This Order also replaces the previous 
language concerning the ability of airlines and aircraft operators to 
request specific waivers and replaces it with a limited humanitarian 
exemption category allowing individuals and organizations to request an 
exemption. To be eligible for this limited humanitarian exemption, the 
individual or organization must demonstrate both: (1) Exigent 
circumstances where emergency travel is required to preserve health and 
safety (e.g., emergency

[[Page 7388]]

medical evacuations); and (2) that predeparture testing cannot be 
accessed or completed before travel. No changes were made to the 
Passenger Attestation.
    This Order 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 conditions outlined in the 
Order.
    A copy of the Order is provided below. A copy of the signed Order 
and Passenger Attestation can be found at https://www.cdc.gov/quarantine/fr-proof-negative-test.html.

Centers for Disease Control and Prevention, Department of Health and 
Human Services

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 1
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    \1\ This Order supersedes the previous order signed by the U.S. 
Centers for Disease Control and Prevention (CDC) Director on January 
12, 2021.
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Summary

    Pursuant to 42 CFR 71.20 and as set forth in greater detail below, 
this Notice and Order prohibit the introduction into the United States 
of any aircraft passenger departing from any foreign country unless the 
passenger: (1) Has a negative pre-departure test result for SARS-CoV-2, 
the virus that causes COVID-19 (Qualifying Test); or (2) written or 
electronic documentation of recovery from COVID-19 after previous SARS-
CoV-2 infection in the form of a positive viral test result and a 
letter from a licensed health care provider or public health official 
stating that the passenger has been cleared for travel (Documentation 
of Recovery).
    The negative pre-departure test must be a viral test that was 
conducted on a specimen collected during the 3 days preceding the 
flight's departure from a foreign country (Qualifying Test). 
Alternatively, if the passenger has recovered from COVID-19, the 
passenger may instead travel with written or electronic documentation 
of a positive viral test result that confirms previous SARS-CoV-2 
infection and a letter from a licensed health care provider or public 
health official stating that the passenger has been cleared for travel 
(Documentation of Recovery). A passenger must retain written or 
electronic documentation reflecting the negative Qualifying Test result 
or Documentation of Recovery presented to the airline or other aircraft 
operator. A passenger must also produce such Qualifying Test result or 
Documentation of Recovery 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 Order constitute 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 following 
conditions to receive permission for the aircraft to enter and 
disembark passengers in the United States:
     Airline or other aircraft operator must verify that every 
passenger--2 years of age or older--onboard the aircraft has attested 
to receiving a negative Qualifying Test result or to having recovered 
from COVID-19 after previous SARS-CoV-2 infection and being cleared to 
travel by a licensed health care provider or public health official.
     Airline or other aircraft operator must confirm that every 
passenger onboard the aircraft has documentation of a negative 
Qualifying Test result or Documentation of Recovery from COVID-19.

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

    Aircraft shall have the same definition as under 42 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 CFR71.1(b).
    Attest/Attestation means having completed the attestation in 
Attachment A. Such attestation may be completed in written or 
electronic form. The attestation is a statement, writing, entry, or 
other representation under 18 U.S.C. 1001.\2\
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    \2\ CDC encourages airline or aircraft operator to incorporate 
the attestation into paperless check-in processes. Airline or 
aircraft operator may use a third party (including a third-party 
application) to collect attestations, including to provide 
translations. But 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. Airline or aircraft operator is 
responsible for any failure of a third party to comply with this 
Order. Airline or aircraft operator may not shift any legal 
responsibility to a third party.
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    Confirm that every passenger onboard the aircraft has documentation 
reflecting a negative Qualifying Test result means confirmation that:

    (1) The personal identifiers (e.g., name and date of birth) on 
the negative Qualifying Test result match the personal identifiers 
on the passenger's passport or other travel documents;
    (2) if the passenger is arriving on a direct flight to the 
United States, the specimen was collected within the 3 days 
preceding the flight's departure;
    (3) if the passenger is arriving via one or more connecting 
flights the specimen was collected within the 3 days preceding the 
departure of the initial flight;
    (4) the test performed was a viral test (as defined below); and
    (5) the test result states ``NEGATIVE,'' ``SARS-CoV-2 RNA NOT 
DETECTED,'' ``SARS-CoV-2 ANTIGEN NOT DETECTED,'' or ``COVID-19 NOT 
DETECTED.'' A test marked ``invalid'' is not acceptable.

    Confirm that a passenger alternatively has written or electronic 
documentation of recovery from COVID-19 means confirmation that:

    (1) The passenger has presented documentation of a positive test 
result and a signed letter on official letterhead that contains the 
name, address, and phone number of a licensed healthcare provider or 
public health official stating that the passenger has been cleared 
for travel; \3\
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    \3\ Health care 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.
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    (2) the positive test result occurred within the last three 
months (90 days) preceding the passenger's flight to the United 
States, or at such other intervals as specified in CDC guidance; \4\
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    \4\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
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    (3) the personal identifiers (e.g., name and date of birth) on 
the positive test result and signed letter match the personal 
identifiers on the passenger's passport or other travel documents;
    (4) the test performed was a viral test (as defined below); and

[[Page 7389]]

    (5) the test result states ``POSITIVE,'' ``SARS-CoV-2 RNA 
DETECTED,'' ``SARS-CoV-2 ANTIGEN DETECTED,'' or ``COVID-19 
DETECTED.'' A test marked ``invalid'' is not acceptable.

    Foreign country means anywhere that is not a state, territory, or 
possession of the United States.
    Negative Pre-departure Test Result for COVID-19 or negative 
Qualifying Test result means documentation of a negative COVID-19 test 
taken within the 3 days preceding a flight's departure. Such 
documentation may be in paper or electronic format as required by this 
Order. Testing must be performed using a viral test. The documentation 
must also include sufficient verification information--such as the name 
and contact information for the laboratory or healthcare personnel who 
performed the test.
    Viral test means a viral detection test for current infection 
(i.e., a nucleic acid amplification test or a viral antigen test) 
approved or authorized by the relevant national authority for the 
detection of SARS-CoV-2.
    United States has the same meaning as ``State'' and ``U.S. 
Territory'' in 42 CFR 71.1(b).

Exemptions

    The following categories of individuals and organizations are 
exempt from the requirements of this Order:
     Crew members of airlines or other aircraft operators 
provided that 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).\5\
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    \5\ https://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/safo/all_safos/media/2020/SAFO20009.pdf. Airlines, aircraft operators, and their crew members 
may follow even stricter protocols for safety, including testing 
protocols.
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     Airlines or other aircraft operators transporting 
passengers with COVID-19 pursuant to CDC authorization and in 
accordance with CDC guidance.\6\
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    \6\ 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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     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 in accordance with CDC guidance. Those traveling for 
training or other business purposes remain subject to the requirements 
of this Order.
     U.S. Department of Defense (DOD) personnel, including 
military personnel and civilian employees, dependents, contractors 
(including whole aircraft charter operators), and other U.S. government 
employees when traveling on DOD assets, provided that such individuals 
are under competent military or U.S. government travel orders and 
observing DOD precautions to prevent the transmission of COVID-19 as 
set forth in Force Protection Guidance Supplement 14--Department of 
Defense Guidance for Personnel Traveling During the Coronavirus Disease 
2019 Pandemic (December 29, 2020) including its testing guidance.
     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. 
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 or spread.

Background

    The COVID-19 pandemic has spread throughout the world. Individuals 
who travel may be at risk for exposure to SARS-CoV-2 before, during, 
and after travel. This could result in U.S.-bound travelers further 
spreading the virus to others during travel, upon arrival in the United 
States, and at their destinations.
    Over the last few weeks, the United Kingdom (UK) has faced a rapid 
increase in COVID-19 cases in South East England, leading to enhanced 
epidemiological and virological investigations. On December 14, 2020, 
Public Health England announced that a new variant of SARS-CoV-2 had 
been identified across the southeast of England.\7\ Preliminary 
analysis in the UK suggests that this SARS-CoV-2 variant may be more 
transmissible than previously circulating variants, with an estimated 
potential to increase the reproductive number (R0) by 0.4-
0.7 or greater with an estimated increased transmissibility of up to 70 
percent.\8\
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    \7\ https://www.gov.uk/government/news/phe-investigating-a-novel-variant-of-covid-19.
    \8\ https://www.ecdc.europa.eu/en/publications-data/threat-assessment-brief-rapid-increase-sars-cov-2-variant-united-kingdom.
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    On December 19, 2020, in response to the emergence of the UK 
variant, the countries comprising the UK announced stricter measures to 
be applied from December 20 and over the coming weeks, with affected 
areas entering a `Tier 4' level with movement restrictions within and 
between more and less heavily affected areas. These measures have 
included recommendations for residents of the most affected areas to 
restrict movements and travel, including international travel, outside 
of these areas. The government of Scotland announced a travel ban 
between Scotland and the rest of the UK. In addition, the Netherlands 
issued a travel ban from the UK effective through January 1, 2021, and 
Belgium temporarily halted flight and train travel from the UK. Other 
countries took similar measures to restrict travel from the UK.
    A second new variant of SARS-CoV-2 was reported in the Republic of 
South Africa (RSA) on December 18, 2020, that also appears to spread 
more rapidly than earlier variants of the virus. The RSA variant is 
distinct from the UK variant but shares a mutation in the spike protein 
that appears to increase transmissibility. Since being identified, the 
new variant has spread inland from coastal regions of RSA and has 
become the predominant variant in some areas of the country.
    During December 21-26, 2020, several countries implemented 
restrictions on travel from South Africa, including China, El Salvador, 
Germany, Guatemala, Israel, Panama, Sudan, Switzerland, Turkey, and the 
UK. The Netherlands imposed a ban on travel from RSA on December 21 but 
lifted the ban for both the UK and RSA on December 23, stating that 
travelers will instead need to present a negative COVID-19 test result 
obtained within 72 hours of their scheduled arrival in the Netherlands, 
followed by 10 days of self-quarantine. On December 28, Japan imposed a 
ban on entry of all foreign nationals through the end of January 2021. 
On December 28, the Government of South Africa announced new 
restrictions on businesses and public movement. As of January 7, 2021, 
Canada requires air passengers 5 years of age or older to test negative 
for COVID-19 before arrival. On January 8, the United Kingdom announced 
a pre-departure testing requirement for all inbound international 
travelers with limited exceptions; a 10-day post-arrival quarantine 
will still be required.
    On December 25, 2020, CDC issued an Order requiring proof of a 
negative Qualifying Test result for all airline

[[Page 7390]]

passengers arriving from the UK to the United States. Since then, cases 
of the UK and RSA variants have been discovered in four Canadian 
provinces, including in individuals with no travel history indicating 
spread in Canada. The UK variant has also been found in at least 50 
countries and the RSA variant has also been detected in at least 15 
countries. The first case of the UK variant in the United States was 
found in Colorado on December 29, in an individual with no known travel 
history. On December 30, a second case was reported in California. 
Since then, the UK variant strain has accounted for 144 cases in 20 
U.S. states. Another new variant strain of concern initially detected 
in South America in March 2020 has been detected in at least 19 
countries on 5 continents through late December and has mutations in 
the spike protein that raise concerns of increased infectivity.
    While it is known and expected that viruses constantly change 
through mutation leading to the emergence of new variants, these new 
variants have emerged at a time when numbers of new cases in the United 
States have continued to increase at alarming rates. Additional new 
virus variants are also likely to emerge as the virus continues to 
evolve and mutate. Accordingly, further action is needed to help 
mitigate the spread of these and other new virus variants into the 
United States.
    Based on increased transmissibility and spread of these new 
variants of SARS-CoV-2, and to reduce introduction and spread of these 
and future SARS-CoV-2 variants into the United States, expanding 
current UK pre-departure testing requirements to all foreign countries 
and U.S.-bound passengers is warranted. This approach to testing-based 
risk assessment 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.\9\ Testing for SARS-
CoV-2 infection is a proactive approach and not dependent on the 
infecting strain. Approximately 120 countries now use testing in some 
form to monitor risk and control introduction and spread. With case 
counts and deaths due to COVID-19 continuing to increase around the 
globe and the high proportion of infected people with asymptomatic or 
pre-symptomatic infections, the United States must take a dual approach 
to combatting the virus. This means concurrently mitigating and slowing 
the introduction and spread of SARS-CoV-2 and controlling transmission 
within U.S. communities that are currently being overwhelmed by a surge 
in infections, hospitalizations, and deaths.
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    \9\ Runway to Recovery 1.1, December 21, 2020, available at 
https://www.transportation.gov/briefing-room/runway-recovery-11.
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    Pre-departure testing may detect travelers infected with SARS-CoV-2 
before they initiate their travel. CDC recommends viral testing and 
receipt of results 1-3 days \10\ before departure for international 
travelers, particularly those traveling long distances or passing 
through transportation hubs such as airports where social distancing 
may be challenging. CDC modeling indicates that pre-departure testing 
is most effective when combined with self-monitoring.\11\ Testing 
before departure results in the greatest reduction of transmission risk 
during travel when the specimen is collected close to the time of 
departure. Earlier testing (i.e., more than 3 days before travel) 
provides little benefit beyond what self-monitoring alone can provide.
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    \10\ https://www.cdc.gov/coronavirus/2019-ncov/travelers/testing-air-travel.html.
    \11\ Johansson MA, Wolford H, Paul P, et al. Reducing travel-
related SARS-CoV-2 transmission with layered mitigation measures: 
Symptom monitoring, quarantine, and testing, available at https://www.medrxiv.org/content/10.1101/2020.11.23.20237412v1.
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    For persons previously diagnosed with COVID-19 who remain 
asymptomatic after recovery, CDC does not recommended retesting 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.\12\ Persons who develop any symptoms of 
COVID-19 during this time period should not travel and seek care for 
testing and evaluation. This guidance may be updated as additional 
information about people who have recovered from COVID-19 becomes 
available.
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    \12\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
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    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, social distancing, 
and hand hygiene, it can make travel safer by reducing spread on 
conveyances, in transportation hubs, and at destinations. For 
international air travelers and others with higher risk of exposure, 
CDC additionally recommends a post-arrival test 3-5 days after arrival 
at destination, combined with self-monitoring and a 7-day period of 
staying home (or in a comparable location such as a hotel room) to 
further reduce the risk of translocating the virus into destination 
communities.\13\
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    \13\ https://www.cdc.gov/coronavirus/2019-ncov/travelers/after-travel-precautions.html.
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    As cases of COVID-19 continue to rise across the globe and travel 
volume increases, routine pre-departure testing of all U.S.-bound 
aircraft passengers is needed not only to reduce introduction of the 
two known SARS-CoV-2 variants from UK and RSA, but also future variants 
that might be more transmissible and cause more severe illness.

Action

    For these reasons, I hereby determine that passengers covered by 
this Order are at risk of transmitting the new SARS-CoV-2 virus 
variants or other potential 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.
1. Requirements for Airlines & Other Aircraft Operators
    Any airline or other aircraft operator with passengers arriving 
into the United States from a foreign country, for each passenger 
onboard the aircraft arriving into the United States, shall--
    a. Verify that each passenger has attested to having received 
either a negative Qualifying Test result or to recovery from COVID-19 
after previous SARS-CoV-2 infection and clearance 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.
    b. Confirm that each passenger aged 2 years or older has 
documentation of a negative Qualifying Test result or Documentation of 
Recovery from COVID-19.
    c. Not board any passenger without verifying the attestation and 
confirming the documentation as set forth in 1.a-b.
    Any airline or other aircraft operator that fails to comply with 
section 1, ``Requirement 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 departing from any foreign country with a 
destination in the United States shall--
    (a) Provide an attestation to the CDC, through the airline or other 
aircraft

[[Page 7391]]

operator, of having received a negative Qualifying Test result or of 
recovery from COVID-19 after previous SARS-CoV-2 infection and 
clearance to travel. The attestation is attached to this order as 
Attachment A. Unless otherwise permitted by law, a parent or other 
authorized individual should attest on behalf of a passenger aged 2 to 
17 years. An authorized individual may attest on behalf to any 
passenger who is unable to attest on his or her own behalf (e.g., by 
reason of physical or mental impairment).
    (b) Retain a copy of the negative Qualifying Test result or 
Documentation of Recovery from COVID-19 in his/her possession and 
present it for inspection to the airline and upon request by an agent 
of the U.S. government or a cooperating state or local public health 
authority.
    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 CFR71.2, 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.
    CDC may modify this Order by an updated publication in the Federal 
Register or by posting an advisory to follow at www.cdc.gov.
    This Order shall be enforceable through the provisions of 18 U.S.C. 
3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR71.2.

Effective Date

    This Order shall enter into effect on January 26, 2021 and shall 
remain in effect until the earliest of (1) the expiration of the 
Secretary of Health and Human Services' declaration that COVID-19 
constitutes a public health emergency; (2) the CDC Director rescinds or 
modifies the order based on specific public health or other 
considerations; or (3) December 31, 2021.

Authority

    The authority for these orders is Sections 361 and 365 of the 
Public Health Service Act (42 U.S.C. 264) and 42 CFR 71.20 & 71.31(b).

    Dated: January 26, 2021.
Sherri Berger,
Acting Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-01977 Filed 1-26-21; 4:15 pm]
BILLING CODE 4163-18-P