Emergency Request Memo - signed

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health
Service
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30333
January 26, 2021

Dominic Mancini
Acting Deputy Director
Office of Information and Regulatory Affairs
Office of Management and Budget
Washington, D.C.
Subject: Request for Emergency Clearance
Dear Mr. Mancini:
Pursuant to the Office of Management and Budget (OMB) procedures established at 5
CFR 1320, Controlling Paperwork Burdens on the Public, I request that the following
collection of information, Requirement for Negative Pre-Departure Covid-19 Test Result
or Documentation Of Recent Recovery From Covid-19 for all Airline or Other Aircraft
Passengers Arriving into the United States From Any Foreign Country, be processed in
accordance with section 1320.13 Emergency Processing.
Over the last few weeks, the United Kingdom (UK) has faced a rapid increase in COVID19 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. 1
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. 2
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,
1

https://www.gov.uk/government/news/phe-investigating-a-novel-variant-of-covid-19.
https://www.ecdc.europa.eu/en/publications-data/threat-assessment-brief-rapid-increase-sars-cov-2variant-united-kingdom.
2

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 selfquarantine. 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 postarrival quarantine will still be required.
On December 25, 2020, CDC issued an Order requiring proof of a negative Qualifying
Test result for all airline 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 more than 140 cases in more than 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. 3 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.
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 4 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. 5 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.
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. 6 For these travelers, the
requirement under this order is that they submit their positive test from the last three
months and documentation of recovery from COVID-19 and clearance for travel issued
by a licensed healthcare provider or health department.
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 postarrival test 3-5 days after arrival at destination, combined with self-monitoring and a 7day 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. 7
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.
As such, I have determined that this information must be collected prior to the expiration
of time periods established under Part 1320, and that this information is essential to
3

Runway to Recovery 1.1, December 21, 2020, available at https://www.transportation.gov/briefing-room/runway-recovery-11
https://www.cdc.gov/coronavirus/2019-ncov/travelers/testing-air-travel.html.
5 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.
6 https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html
7 https://www.cdc.gov/coronavirus/2019-ncov/travelers/after-travel-precautions.html
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CDC’s ability to effectively address this public health emergency. CDC cannot
reasonably comply with the normal clearance procedures due to the public harm that
could result if routine processing of this request is required. CDC requests emergency
clearance to require air travelers from all foreign countries to the US to provide negative
COVID-19 tests to airlines prior to boarding and to attest that those tests are truthful and
accurate.
The information will not be collected or maintained by CDC and is instead primarily a 3rd
party disclosure requirement between travelers and airlines. In limited circumstances,
CDC may require that the traveler provide the test results in the course of a specific
public health response. However, travelers are expected to retain these materials.
Please provide an approval/disapproval determination of this request to collect
information under an emergency clearance by close of business Wednesday, January 27,
2021.

Respectfully,
Rima F. Khabbaz -S

Digitally signed by Rima F. Khabbaz S
Date: 2021.01.26 16:40:20 -05'00'

Rima Khabbaz, MD
Director
National Center for Emerging and Zoonotic
Infectious Diseases
Centers for Disease Control and Prevention