[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
[Rules and Regulations]
[Pages 16559-16567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06238]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[Docket No. CDC-2020-0033]
RIN 0920-AA76
Control of Communicable Diseases; Foreign Quarantine: Suspension
of Introduction of Persons Into United States From Designated Foreign
Countries or Places for Public Health Purposes
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Interim final rule with request for comments.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the U.S. Department of Health and Human Services (HHS) issues this
interim final rule with request for comments to amend its Foreign
Quarantine Regulations. This interim final rule provides a procedure
for CDC to suspend the introduction of persons from designated
countries or places, if required, in the interest of public health.
DATES:
Effective date: This interim final rule is effective on 11:59 p.m.
EDT on March 20th, 2020.
Comment date: Written comments are invited and must be submitted on
or before 30 days from the date of publication of this interim final
rule in the Federal Register.
Expiration date: Unless extended after consideration of submitted
comments, this interim final rule will cease to be in effect on the
earlier of (1) one year from the publication of this interim final
rule, or (2) when the HHS Secretary determines there is no longer a
need for this interim final rule. The Secretary will publish a document
in the Federal Register announcing the expiration date.
[[Page 16560]]
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0033, by the following method:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name
and docket number or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://regulations.gov, including any personal information provided.
For access to the docket to read background documents or comments
received, go to http://www.regulations.gov.
Any comment that is submitted will be shared with the Department of
Homeland Security and the Department of State, and will also be made
available to the public. Comments must be identified by RIN 0920-AA76.
Because of staff and resource limitations, all comments must be
submitted electronically to www.regulations.gov. Follow the ``Submit a
comment'' instructions.
Warning: Do not include any personally identifiable information
(such as name, address, or other contact information) or confidential
business information that you do not want publicly disclosed. All
comments may be posted on the internet and can be retrieved by most
internet search engines. No deletions, modifications, or redactions
will be made to comments received.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including personally identifiable or confidential business information
that is included in a comment.
FOR FURTHER INFORMATION CONTACT: Kyle McGowan, Office of the Chief of
Staff, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-10, Atlanta, GA 30329. Telephone: 404-498-7000; email:
cdcregulations@cdc.gov.
SUPPLEMENTARY INFORMATION: The IFR is organized as follows:
Table of Contents
I. Background
II. Statutory Authority
III. Provisions of New Sec. 71.40
IV. Request for Comment
V. Rationale for Issuance of an Interim Final Rule With Immediate
Effectiveness
VI. Regulatory Impact Analysis
I. Background
The Centers for Disease Control and Prevention (CDC), a component
of the U.S. Department of Health and Human Services (HHS), is amending
the regulations that implement section 362 of the Public Health Service
(PHS) Act, 42 U.S.C. 265, as part of its response to Coronavirus
Disease 2019 (COVID-19). Section 362 provides that if the Secretary \1\
``determines that by reason of the existence of any communicable
disease in a foreign country there is serious danger of the
introduction of such disease into the United States, and that this
danger is so increased by the introduction of persons or property from
such country that a suspension of the right to introduce such persons
and property is required in the interest of the public health,'' he has
the authority, in accordance with regulations approved by the
President,\2\ ``to prohibit, in whole or in part, the introduction of
persons and property from such countries or places as he shall
designate in order to avert such danger, and for such period of time as
he may deem necessary for such purpose.'' PHS Act 362, 42 U.S.C. 265.
Pursuant to a delegation of the Secretary's authority, the CDC Director
has promulgated regulations under section 362 to suspend the
introduction of property into the United States. Current regulations,
however, only address suspension of the introduction of property into
the United States and the procedures to quarantine or isolate persons.
That is, current regulations permit CDC to quarantine or isolate
persons entering the United States, but they do not address the
suspension of the introduction of persons into the United States under
section 362.
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\1\ The statute assigns this authority to the Surgeon General of
the Public Health Service. However, Reorganization Plan No. 3 of
1966 abolished the Office of the Surgeon General and transferred all
statutory powers and functions of the Surgeon General and other
officers of the Public Health Service and of all agencies of or in
the Public Health Service to the Secretary of Health, Education, and
Welfare, now the Secretary of Health and Human Services, 31 FR 8855,
80 Stat. 1610 (June 25, 1966), see also Public Law 96-88, 509(b), 93
Stat. 695 (codified at 20 U.S.C. 3508(b)). References in the PHS Act
to the Surgeon General are to be read in light of the transfer of
statutory functions and re-designation. Although the Office of the
Surgeon General was re-established in 1987, the Secretary of HHS has
retained the authorities previously held by the Surgeon General.
\2\ Executive Order 13295 assigned the functions of the
President under section 362 to the Secretary of HHS.
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CDC's experience with COVID-19 is that, under some circumstances,
quarantine or isolation is not a viable solution for protecting the
public health from the introduction of a communicable disease from
another country. For example, the arrival in U.S. ports of cruise ships
with numerous passengers requiring quarantine or isolation has
presented complex logistical challenges, consumed disproportionate
agency resources, and taken CDC personnel away from other critical
parts of the domestic and international response to COVID-19. To
continue to respond promptly and effectively to the public health
emergency presented by COVID-19, CDC needs a more efficient regulatory
mechanism to exercise its section 362 authority and suspend the
introduction of persons who would otherwise pose a serious danger of
introduction of COVID-19 into the United States.
Even though COVID-19 is present in certain locations within the
United States, the suspension of the introduction of persons into the
United States may be required in the interest of public health to avert
the danger of further introduction of the disease into the same or
other locations in the United States. For example, hypothetically, the
introduction of COVID-19 into the United States would occur if two
infected persons disembarked in a large metropolitan city in the
Midwest from an international flight. Another vector for further
introduction of COVID-19 into the United States would be a group of two
infected persons who entered that Midwestern state by land after
crossing the border from Canada. Suspension of the introduction of
those two persons into the United States at the land border would
mitigate the serious and increased danger of further introduction of
COVID-19 in the United States. The same public health analysis would
apply if two infected persons walked across the land border from Canada
into a Northeastern State.
Past Experience With Migration and Communicable Disease
International travel and migration play a significant role in the
global transmission of infectious biological agents or their toxic
products that pose risks for vulnerable populations.\3\ Travelers can
serve as unwitting vectors of disease, and thereby increase the risk of
communicable disease transmission and of the introduction of
communicable disease into the United States. The risk increases when
travelers are in congregate settings, such as
[[Page 16561]]
carriers (i.e., ships, aircraft, trains, and road vehicles) or
terminals with shared sitting, sleeping, eating, or recreational areas,
all of which are conducive to disease transmission.\4\
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\3\ See, e.g., Institute of Medicine (US) Forum on Microbial
Threats, ``Infectious Disease Movement in a Borderless World:
Workshop Summary,'' National Academies Press (US); 2010, available
at https://www.ncbi.nlm.nih.gov/books/NBK45728/ (hereinafter
``Infectious Disease Movement in a Borderless World''); Wilson, ME.
Travel and the Emergence of Infectious Diseases. Emerging Infectious
Diseases. 1995;1(2):39-46. doi:10.3201/eid0102.950201; Tatem, A.J.,
Rogers, D.J. & Hay, S. Global Transport Networks and Infectious
Disease Spread. Adv. Parasitology 62, 293-343 (2006).
\4\ E.g., https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-by-air-land-sea/cruise-ship-travel (noting that the ``often crowded,
semi-enclosed environments onboard ships can facilitate the spread
of person-to-person, foodborne, or waterborne diseases''); CDC,
``Interim US Guidance for Risk Assessment and Public Health
Management of Persons with Potential Coronavirus Disease 2019
(COVID-19) Exposures: Geographic Risk and Contacts of Laboratory-
confirmed Cases,'' Updated March 7, 2020, available at https://www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.html.
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The speed and far reach of global travel were factors in prior
outbreaks that expanded to numerous continents. Examples include: The
H1N1 influenza pandemic in 2009; severe acute respiratory syndrome
(SARs) coronavirus in 2003; tuberculosis; measles; Middle East
Respiratory Syndrome (MERS-CoV) in 2012; and Ebola Virus Disease in
2014 and 2018.\5\ All of these high-consequence diseases posed
significant public health risks, especially given the compressed
timeframes in which the outbreaks occurred.
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\5\ Infectious Disease Movement in a Borderless World (noting
that ``swine-origin H1N1 has spread globally, its movement hastened
by global air travel'' and [i]t is easy to see how travelers could
play a key role in the global epidemiology of infections that are
transmitted from person to person, such as HIV, SARS, tuberculosis,
influenza, and measles'') (citing Hufnagel L, Brockmann D, Geisel T.
Forecast and Control of Epidemics in a Globalized World. Proceedings
of the National Academy of Sciences. 2004;101(42):15124-15129).
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For example, the Federal response to the H1N1 influenza pandemic in
2009 would have benefitted from the availability of an efficient
mechanism for suspending the introduction of persons into the United
States. The initial cases of H1N1 occurred in Mexico, before the first
confirmed cases in the United States. Retrospective research findings
in Mexico indicated that transmission of the virus in Mexico involved
person-to-person spread with multiple generations of transmission.\6\
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\6\ https://www.cdc.gov/h1n1flu/cdcresponse.htm.
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Like 2009 H1N1, COVID-19 is a pandemic. But the new coronavirus is
more infectious than 2009 H1N1.\7\ Indeed, it appears that the virus
may at times be transmitted by persons who are asymptomatic. As
discussed below, COVID-19 is also more likely to cause death in high-
risk individuals.
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\7\ See generally, CDC, ``2009 H1N1 Pandemic Timeline,''
available at https://www.cdc.gov/flu/pandemic-resources/2009-pandemic-timeline.html; Van Kerkhove, Maria D et al. Estimating age-
specific cumulative incidence for the 2009 influenza pandemic: A
meta-analysis of A(H1N1)pdm09 serological studies from 19 countries.
Influenza and Other Respiratory Viruses vol. 7,5 (2013): 872-86,
available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5781221/;
CDC, Interim Clinical Guidance for Management of Patients with
Confirmed Coronavirus Disease (COVID-19), available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html.
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In addition, global travel has increased dramatically since prior
infectious disease outbreaks. By 2018, international visitations to the
U.S. totaled over 20 million more per year than in 2009, when the 2009
H1N1 pandemic occurred, and 10 million more per year than in 2014, when
the Ebola Virus Disease outbreak occurred.\8\ These differences make
the availability of an efficient mechanism for exercising the section
362 authority all the more important to the protection of the public
health going forward.
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\8\ https://travel.trade.gov/outreachpages/download_data_table/Fast_Facts_2018.pdf.
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The Current Outbreak of COVID-19
COVID-19 is a communicable disease caused by a novel (new)
coronavirus, SARS-CoV-2, that was first identified as the cause of an
outbreak of respiratory illness that began in Wuhan, Hubei Province,
People's Republic of China (``PRC''). The virus is thought to be
transmitted primarily by person-to-person contact through respiratory
droplets produced when an infected person coughs or sneezes. It may
also be transmitted through contact with surfaces or objects. While
much is still unknown about the transmission of COVID-19, asymptomatic
transmission may also occur.
Manifestations of severe disease have included severe pneumonia,
acute respiratory distress syndrome (ARDS), septic shock, and multi-
organ failure. According to the World Health Organization (WHO), as of
March 17, 2020, approximately 4.1% of reported COVID-19 cases have
resulted in death globally. This mortality rate is higher among seniors
or those with compromised immune systems. Older adults and people who
have severe chronic medical conditions like hypertension, heart, lung,
or kidney disease are also at higher risk for more serious COVID-19
illness. Early data suggest older people are twice as likely to have
serious COVID-19 illness.
As of March 17, 2020, there were over 179,100 cases of COVID-19
globally in over 150 locations (including countries), resulting in over
7,425 deaths; more than 4,225 cases have been identified in the United
States, with new cases being reported daily and with at least 75 deaths
due to the disease. Continued introduction into the United States of
persons from foreign countries where COVID-19 exists presents a danger
of disease transmission in congregate settings such as carriers or
terminals, which may, in turn, result in a danger of disease
transmission in contiguous areas.\9\
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\9\ See supra n.4; see also CDC, Travelers from Countries with
Widespread Sustained (Ongoing) Transmission Arriving in the United
States, available at https://www.cdc.gov/coronavirus/2019-ncov/travelers/after-travel-precautions.html.
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Unfortunately, at this time, there is no vaccine that can prevent
infection with COVID-19, nor are there therapeutics for those who
become infected. Treatment is currently limited to supportive (or
palliative) care to manage symptoms while the body fights off the
disease. Hospitalization may be required in severe cases and mechanical
respiratory support may be needed in the most severe cases. The ease of
COVID-19 transmission presents a risk of a surge in hospitalizations
for COVID-19, which would limit hospital capacity available to treat
other serious conditions.
Testing is available to confirm suspected cases of COVID-19
infection. Testing generally requires specimens collected from the
nose, throat, or lungs; such specimens can only be analyzed in a
laboratory setting. However, commercial test results are typically
available within three to four days. Currently, the time required to
obtain test results--coupled with the incubation period of the
disease--makes it impracticable to confirm whether each person moving
into the United States is infected with COVID-19 at the time of the
movement. Widespread, compulsory Federal quarantines or isolations of
such persons pending test results are impracticable due to the numbers
of persons involved, logistical challenges, and CDC resource and
personnel constraints.
On January 30, 2020, the Director General of WHO declared that the
outbreak of COVID-19 is a Public Health Emergency of International
Concern under the International Health Regulations.\10\ The following
day, the Secretary of HHS declared COVID-19 a public health emergency
under the PHS Act.\11\ On March 11, 2020, the WHO declared COVID-19 a
pandemic. On March 13, 2020, the President issued a
[[Page 16562]]
Proclamation on Declaring a National Emergency Concerning the Novel
Coronavirus Disease (COVID-19) Outbreak.\12\ As of March 16, 2020, all
50 states and several local and territorial jurisdictions declared
states of emergency.
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\10\ Statement on the second meeting of the International Health
Regulations (2005) Emergency Committee regarding the outbreak of
novel coronavirus (2019-nCoV) (January 30, 2020), available at
https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-
emergency-committee-regarding-the-outbreak-of-novel-coronavirus-
(2019-ncov).
\11\ HHS, ``Determination that a Public Health Emergency
Exists,'' available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
\12\ ``Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak,'' March 13, 2020,
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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Global efforts to slow disease transmission have included sweeping
measures to limit travel and exposure to COVID-19. A number of
countries, such as Russia, Australia, the Philippines, Japan, and
Israel, have imposed stringent restrictions on travelers who have
recently been to the PRC. On March 17, 2020, the European Union
approved a plan to ban all nonessential travel into its bloc for a
minimum of 30 days. Many countries are asking persons to self-
quarantine for 14 days (a period estimated to encompass the incubation
period for the disease) following return from foreign countries or
places with sustained community transmission.
The President has exercised his authority in section 212(f) of the
Immigration and Nationality Act (``INA''), 8 U.S.C. 1182(f), to suspend
entry into the United States of certain foreign nationals who have
recently visited PRC (excluding the Special Administrative Regions of
Hong Kong and Macau), the Islamic Republic of Iran, the Schengen Area
(comprised of 26 countries in Europe), the United Kingdom (excluding
overseas territories outside of Europe), and the Republic of Ireland,
within 14 days preceding their entry or attempted entry into the United
States due to concerns of person-to-person transmission of COVID-19.
CDC has issued Level 3 Travel Health Notices recommending that
travelers avoid all nonessential travel to PRC (excluding the Special
Administrative Regions of Hong Kong and Macau), the Islamic Republic of
Iran, the Republic of Korea, and the Schengen Area. The U.S. Department
of State has issued a Global Level 3 Health Advisory directing U.S.
citizens to reconsider all travel abroad due to the global impact of
COVID-19 and Level 4 Travel Advisories (Do Not Travel) for PRC
(excluding the Special Administrative Regions of Hong Kong and Macau),
Iran, and certain regions of Italy. In addition, CDC has recommended
that travelers, particularly those with underlying health conditions,
avoid all cruise ship travel worldwide. The U.S. Department of State
has similarly issued guidance that U.S. citizens should not travel by
cruise ship at this time. On March 16, 2020, the Federal government
announced guidelines recommending that the public should avoid
discretionary travel; discretionary shopping trips; social visits;
gatherings in groups of more than 10 people; and eating or drinking at
bars, restaurants, and food courts. Numerous States and cities have
gone further and shut down restaurants, bars, nightclubs, and theaters.
On March 18, 2020, the United States and Canada announced plans to, by
mutual consent, close the U.S.-Canadian border to nonessential travel.
The COVID-19 pandemic highlights why CDC needs an efficient
regulatory mechanism to suspend the introduction of persons who would
otherwise increase the serious danger of the introduction of a
communicable disease into the United States. Section 212(f) of the
Immigration and Nationality Act (``INA'') applies to the ``entry'' of
aliens, but section 362 instead provides the authority to prohibit the
``introduction'' of persons into the United States. Despite the
unprecedented global efforts at mitigating or slowing the transmission
of COVID-19, cases of COVID-19 have rapidly propagated and multiplied,
crossing international borders with ease. As of March 17, 2020, CDC
reported that 229 of the confirmed cases of COVID-19 in the United
States with an established source of exposure were travel-related as
opposed to community transmission, accounting for almost half of the
474 cases with an established source of exposure; another 3,752 cases
remain under investigation. As of March 14, 2020, travelers from Japan
have exported at least 20 COVID-19 cases to eight countries. As of
March 14, 2020, travelers from the Islamic Republic of Iran have
exported at least 145 COVID-19 cases to 17 other countries, as reported
by the WHO, and travelers from the Schengen Area have exported 624
COVID-19 cases to 70 countries, including to the United States. In the
near future, persons traveling from other foreign countries and
jurisdictions may compound the serious danger of further introduction
of COVID-19 into the United States.
To summarize, CDC knows that COVID-19 infection transmits easily,
spreads quickly through global travel, and can have a high mortality
rate for some of the most vulnerable members of society. At this time,
there is no vaccine, therapeutic, or rapid testing for the disease. CDC
needs a robust, efficient mechanism for exercising its authority under
section 362 and other applicable authorities to suspend the
introduction of persons into the United States, should the public
health require it. In issuing orders pursuant to this interim final
rule, CDC would coordinate with the Secretary of State in order to
ensure compliance with the international legal obligations of the
United States and to take due account of U.S. national and security
interests.
Other Public Health Risks
Beyond the current COVID-19 pandemic, the suspension authority is
also critical to CDC because there is always a risk of another
emerging, or re-emerging, communicable disease that may harm the
American public. One such risk is pandemic influenza (as opposed to
seasonal influenza), which occurs when a novel, or new, influenza virus
strain spreads over a wide geographic area and affects an exceptionally
high proportion of the population. In such circumstances, the strain of
virus is new, there is usually no available vaccine, and humans do not
typically have immunity to the virus, often resulting in a more severe
illness. The severity and unpredictable nature of an influenza pandemic
requires public health systems to prepare constantly for the next
occurrence. Whenever a new strain of influenza virus appears, or a
major change to a preexisting virus occurs, individuals may have little
or no immunity, which can lead to a pandemic when the virus passes
easily from human to human and causes serious illness or death. The
most recent influenza pandemics include H1N1 in 2009-2010, the 1968-
1969 Hong Kong Flu, the 1957-1958 Asian Flu, and the 1918-1919 Spanish
Flu.
It is difficult to predict the impact that another emerging, or re-
emerging, communicable disease would have on the U.S. public health
system. The 2009 H1N1 pandemic caused between 100,000 and 600,000
deaths worldwide,\13\ while the 1918-1919 Spanish Flu was estimated to
have caused over 50 million deaths worldwide.\14\ Although advances in
health care quality have greatly improved since 1918, the dramatic
increases in global mobility in the 21st century have increased the
rate at which a communicable disease can spread. Modern pandemics,
spread through international travel, can engulf the world in three
months or less. Moreover, pandemics can last from 12
[[Page 16563]]
to 18 months and are not considered one-time events.
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\13\ https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html.
\14\ https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html.
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The introduction of another emerging, or re-emerging, communicable
disease into the United States is always a risk. The PHS Act section
362 suspension authority would be critical to any effort by CDC and its
Federal, State, and local partners to contain or mitigate the risk. CDC
expects to mitigate the risk in the future by issuing a Final Rule,
after considering comments, to implement a permanent regulatory
structure regarding the potential suspension of introduction of persons
into the United States in the event a serious danger of the
introduction of communicable disease arises in the future.
II. Statutory Authority
The primary legal authority supporting this rulemaking is section
362 of the PHS Act, which is codified at 42 U.S.C. 265. Under section
362, the Secretary \15\ has the authority--if he were to determine that
the existence of a communicable disease in a foreign country creates a
serious danger of the introduction of such disease into the United
States, and that this danger is increased by the introduction of
persons or property from such country such that suspension of
introduction is necessary to protect the public health--to suspend, in
accordance with regulations approved by the President,\16\ such
introduction for determined periods of time.
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\15\ See supra at n.1.
\16\ See supra at n.2.
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In addition to section 362, other sections of the PHS Act are
relevant to this rulemaking, including section 311, 42 U.S.C. 243;
section 361, 42 U.S.C. 264; section 365, 42 U.S.C. 268; and section
367, 42 U.S.C. 270. Section 311 authorizes the Secretary to accept
State and local assistance in the enforcement of quarantine rules and
regulations and to assist States and their political subdivisions in
the control of communicable diseases. Section 361 authorizes the
Secretary to make and enforce such regulations that in the Secretary's
judgment are necessary to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries into the United
States. It also permits the ``apprehension, detention, or conditional
release of individuals'' in order to prevent the ``introduction,
transmission, or spread'' of such communicable diseases as may be
specified from time to time in Executive Orders of the President upon
the recommendation of the Secretary, in consultation with the Surgeon
General. Section 365 provides that it shall be the duty of designated
customs officers and of Coast Guard officers to aid in the enforcement
of quarantine rules and regulations.\17\ Section 367 authorizes the
application of certain sections of the PHS Act and promulgated
regulations (including penalties and forfeitures for violations of such
sections and regulations) to air navigation and aircraft to such extent
and upon such conditions as deemed necessary for safeguarding public
health.\18\
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\17\ The terms ``officer of the customs'' and ``customs
officer'' are defined by statute to mean, ``any officer of the
United States Customs Service of the Treasury Department (also
hereinafter referred to as the ``Customs Service'') or any
commissioned, warrant, or petty officer of the Coast Guard, or any
agent or other person, including foreign law enforcement officers,
authorized by law or designated by the Secretary of the Treasury to
perform any duties of an officer of the Customs Service.'' 19 U.S.C.
1401(i). Although this provision refers to the Secretary of the
Treasury, the Homeland Security Act transferred to the Secretary of
Homeland Security all ``the functions, personnel, assets, and
liabilities of . . . the United States Customs Service of the
Department of the Treasury, including the functions of the Secretary
of the Treasury relating thereto . . . [,]'' 6 U.S.C. 203(1), such
that reference to the Secretary of the Treasury should be read to
reference the Secretary of Homeland Security.
\18\ HHS quarantine authorities also apply to vessels. See,
e.g., PHS Act 364 (providing for quarantine stations at anchorages
and vessel quarantine inspections), 366 (providing for bills of
health for vessels, authorizing issuance of regulations applicable
to vessels, and certificate of a quarantine officer before a vessel
can enter any U.S. port to discharge cargo or land passengers).
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III. Provisions of New Sec. 71.40
This interim final rule will implement section 362 and other
applicable provisions of the PHS Act to enable the CDC Director to
suspend the introduction of persons into the United States consistent
with the statute and applicable law.
Section 71.40(a) sets forth the statutory requirements for the CDC
Director to suspend the introduction of persons into the United States.
The provision establishes that the CDC Director may prohibit the
introduction into the United States of persons from designated foreign
countries (or one or more political subdivisions and regions thereof)
or places, only for such period of time that the Director deems
necessary for the public health, by issuing an order in which the
Director determines that:
(1) By reason of the existence of any communicable disease in a
foreign country (or one or more political subdivisions or regions
thereof) or place, there is serious danger of the introduction of such
communicable disease into the United States, and
(2) This danger is so increased by the introduction of persons from
such country (or one or more political subdivisions or regions thereof)
or place that a suspension of the introduction of such persons into the
United States is required in the interest of the public health.
Section 71.40(b) sets forth definitions of several terms used in
Sec. 71.40. CDC defines the ``introduction into the United States of
persons'' from a foreign country (or one or more political subdivisions
or regions thereof) or place'' as the movement of a person from a
foreign country (or one or more political subdivisions or regions
thereof) or a place, or series of foreign countries or places, into the
United States so as to bring the person into contact with others in the
United States, or so as to cause the contamination of property in the
United States, in a manner that the Director determines to present a
risk of transmission of the communicable disease to persons or
property, even if the communicable disease has already been introduced,
transmitted, or is spreading within the United States.
Section 362 refers to the ``introduction of persons'' from foreign
countries. CDC defines ``introduction into the United States of
persons'' from a foreign country (including one or more political
subdivisions or regions thereof) or place to clarify that
``introduction'' can encompass those who have physically crossed a
border of the United States and are in the process of moving into the
interior in a manner the Director determines to present a risk of
transmission of a communicable disease. This additional mechanism to
halt the travel of such persons and rapidly moving them outside the
United States constitutes preventing their ``introduction'' into the
United States for purposes of Sec. 71.40.
Similarly, Section 362 refers to the ``introduction of [a
communicable disease] into the United States.'' CDC defines ``serious
danger of the introduction of such communicable disease into the United
States'' to mean the potential for introduction of vectors of the
communicable disease into the United States, even if persons or
property in the United States are already infected or contaminated with
the communicable disease. CDC establishes this definition to clarify
that, even if persons or property (e.g. animals) in the United States
are already infected or contaminated with a communicable disease in
some localities, the potential for introduction of additional vectors
that would introduce, transmit, or spread the disease in the same or
different localities can present a serious danger of the introduction
of the disease into the United States. Suspension of
[[Page 16564]]
the introduction of persons into the United States may be required, in
the interest of public health, to avert the increased danger that
results from further introduction, transmission, or spread of the
disease within the United States.
Finally, for purposes of this section, CDC defines the term
``place'' to include any location specified by the Director, including
any carrier, whatever the carrier's nationality. CDC does this in order
to remove all doubt that when this interim final rule refers to
``place,'' it refers not just to territory within or outside of a
country, but also to carriers, as that term is defined in 42 CFR 71.1,
whatever the carrier's nationality.
CDC will establish the requirement to suspend the introduction of
persons into the United States from certain designated places for
certain periods of time by means of an order executed by the CDC
Director. In Sec. 71.40(c), CDC describes the required contents of
such order. In any Sec. 71.40 order, the CDC Director must designate:
The foreign countries (or one or more designated political
subdivisions or regions thereof) or places from which the introduction
of persons is being suspended.
The period of time or circumstances under which the
introduction of any persons or class of persons into the United States
is being suspended.
The conditions under which that prohibition on
introduction should be effective in whole or in part, including any
relevant exceptions that the CDC Director determines are appropriate.
CDC might at times rely on (1) State and local authorities who
agree to help implement orders issued pursuant to Sec. 71.40, or (2)
other Federal agencies to implement and execute the orders issued under
this section. Accordingly, in Sec. 71.40(d), CDC establishes that,
before issuing any Sec. 71.40 order, CDC may coordinate with the
appropriate State and local authorities or other Federal agency (or
agencies). If the order will be implemented in whole or in part by
State and local authorities under 42 U.S.C. 243(a), the Director's
order may explain the procedures and standards by which those State or
local authorities are expected to aid in the order's enforcement.
Similarly, if the order will be implemented in whole or in part by
designated customs officers (including officers of the Department of
Homeland Security with U.S. Customs and Border Protection who exercise
the authorities of customs officers) or the United States Coast Guard
under 42 U.S.C. 268(b), or another Federal department or agency, the
CDC Director, in coordination with the Secretary of Homeland Security
or the head of the other applicable department or agency, shall explain
in the order the procedures and standards by which any authorities or
officers or agents are expected to aid in the enforcement of the order,
to the extent that they are permitted to do so under their existing
legal authorities.
Section 71.40(e) provides that this section does not apply to
members of the armed forces of the United States and associated
personnel for whom the Secretary of Defense provides assurance to the
Director that the Secretary of Defense, through measures such as
quarantine, isolation, or other measures maintaining control over such
individuals, is preventing the risk of transmission of a communicable
disease to persons or property in the United States. CDC includes this
exception because the Secretary of Defense has authority and means to
prevent the introduction of a communicable disease into the United
States from his personnel returning from foreign countries. Therefore,
this interim final rule need not apply to Department of Defense
personnel.
Although section 362 applies to ``persons,'' this interim final
rule will not apply to U.S. citizens or lawful permanent residents.
Congress provided CDC with the authority to prohibit the introduction
of persons who would increase a serious danger of introducing into the
United States a communicable disease, when required in the interest of
the public health. CDC believes that, at present, quarantine,
isolation, and conditional release, in combination with other
authorities, while not perfect solutions, can mitigate any transmission
or spread of COVID-19 caused by the introduction of U.S. citizens or
lawful permanent residents into the United States. Section 71.40(f)
therefore explains that this interim final rule shall not apply to U.S.
citizens and lawful permanent residents. Determining the appropriate
protections for U.S. citizens and lawful permanent aliens requires a
complex balancing of numerous interests and would benefit from
additional consideration and public comment. HHS does not want such
concerns to delay the issuance of this interim final rule, which would
enable the CDC Director to issue orders that would have the effect of
slowing the introduction, transmission, and spread of COVID-19 in the
United States.
V. Rationale for Issuance of an Interim Final Rule With Immediate
Effectiveness
Agency rulemaking is governed by section 553 of the Administrative
Procedure Act (APA) (5 U.S.C. 553). Section 553(b) requires that,
unless the rule falls within one of the enumerated exemptions, HHS must
publish a notice of proposed rulemaking in the Federal Register that
provides interested persons an opportunity to submit written data,
views, or arguments, prior to finalization of regulatory requirements.
Section 553(b)(3)(B) of the APA authorizes a department or agency to
dispense with the prior notice and opportunity for public comment
requirement when the agency, for ``good cause,'' finds that notice and
public comment thereon are impracticable, unnecessary, or contrary to
the public interest. In addition, because this interim final rule
represents a critical part of the dialogue between the United States
and the Governments of Mexico and Canada in preventing the spread of
COVID-19 along our shared borders, it involves a ``foreign affairs
function of the United States.'' 5 U.S.C. 553(a)(1).
As noted above, the United States and numerous other countries have
taken unprecedented measures to try to contain or slow the transmission
or spread of COVID-19. Such public health actions, especially the
actions by the President and the Secretary, have slowed the
introduction and transmission of the disease into the United States,
which has benefitted the public health, preserved limited public and
private resources, and given the U.S. public health system additional
time to implement further measures to protect and support the public.
Nevertheless, these measures have not completely stopped global
travelers, and other persons crossing from one country into another
country, from spreading COVID-19 across national boundaries and around
the globe. The introduction of persons from foreign countries with
COVID-19 outbreaks is continuing to cause the introduction of COVID-19
into disparate locations within the United States. The suspension
authority is therefore critical to slowing the introduction of COVID-19
into such disparate locations within the United States. The United
States is in a phase where suspending the introduction of persons from
certain countries or places may be required in the interest of the
public health, because it could still materially reduce the
transmission and spread of COVID-19 in the United States. Because
persons can have COVID-19 and be asymptomatic at the time of
introduction into the United States, and because the completion of
testing for COVID-19 may take three to four days, it is impracticable
to confirm who is infected with COVID-19 and who is not infected with
COVID-19 as persons move into the United States.
[[Page 16565]]
Similarly, Federal quarantines or isolations of all such persons
pending test results would be impracticable due to the numbers of
persons involved, logistical challenges, and CDC resource and personnel
constraints.
In addition, whereas section 212(f) of the INA applies to the
``entry'' of aliens, section 362 applies to the ``introduction'' of
persons into the United States. Therefore, although 212(f) has been
effective in slowing the transmission or spread of COVID-19 in the
United States, section 362 provides CDC with a mechanism tied
specifically to persons who increase the danger of introducing COVID-19
into the United States.
Given the national emergency caused by COVID-19, it would be
impracticable and contrary to the public health--and, by extension, the
public interest--to delay these implementing regulations until a full
public notice-and-comment process is completed.
Pursuant to 5 U.S.C. 553(b)(3)(B), and for the reasons stated
above, HHS therefore concludes that there is good cause to dispense
with prior public notice and the opportunity to comment on this rule
before finalizing this rule. For the same reasons, HHS has determined,
consistent with section 553(d) of the APA, that there is good cause to
make this interim final rule effective immediately upon filing at the
Office of the Federal Register.
IV. Request for Comment
HHS requests comment on all aspects of this interim final rule,
including its likely costs and benefits and the impacts that it is
likely to have on the public health, as compared to the current
requirements under 42 CFR part 71.
VI. Regulatory Impact Analysis
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, and public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a
regulation (1) having an annual effect on the economy of $100 million
or more in any one year, or adversely and materially affecting a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities (also referred to as ``economically significant''); (2)
creating a serious inconsistency or otherwise interfering with an
action taken or planned by another agency; (3) materially altering the
budgetary impacts of entitlement grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order. This
interim final rule is economically significant for the purposes of
Executive Orders 12866 and 13563. CDC, however, is proceeding under the
emergency provision at Executive Order 12866 Section 6(a)(3)(D) based
on the need to move expeditiously during the current public health
emergency to limit the number of new cases of COVID-19.
The Regulatory Flexibility Act (RFA) generally requires that when
an agency issues a proposed rule, or a final rule pursuant to section
553(b) of the APA or another law, the agency must prepare a regulatory
flexibility analysis that meets the requirements of the RFA and publish
such analysis in the Federal Register. 5 U.S.C. 603, 604. Specifically,
the RFA normally requires agencies to describe the impact of a
rulemaking on small entities by providing a regulatory impact analysis.
Such analysis must address the consideration of regulatory options that
would lessen the economic effect of the rule on small entities. The RFA
defines a ``small entity'' as (1) a proprietary firm meeting the size
standards of the Small Business Administration (SBA); (2) a nonprofit
organization that is not dominant in its field; or (3) a small
government jurisdiction with a population of less than 50,000. 5 U.S.C.
601(3)-(6). Except for such small government jurisdictions, neither
State nor local governments are ``small entities.'' Similarly, for
purposes of the RFA, individual persons are not small entities. The
requirement to conduct a regulatory impact analysis does not apply if
the head of the agency ``certifies that the rule will not, if
promulgated, have a significant economic impact on a substantial number
of small entities.'' 5 U.S.C. 605(b). The agency must, however, publish
the certification in the Federal Register at the time of publication of
the rule, ``along with a statement providing the factual basis for such
certification.'' Id. If the agency head has not waived the requirements
for a regulatory flexibility analysis in accordance with the RFA's
waiver provision, and no other RFA exception applies, the agency must
prepare the regulatory flexibility analysis and publish it in the
Federal Register at the time of promulgation or, if the rule is
promulgated in response to an emergency that makes timely compliance
impracticable, within 180 days of publication of the final rule. 5
U.S.C. 604(a), 608(b).\19\
---------------------------------------------------------------------------
\19\ An agency head may delay the completion of the regulatory
impact analysis requirements for a period of not more than 180 days
after the date of publication in the Federal Register of a final
rule by publishing in the Federal Register, not later than such date
of publication, a written finding, with reasons therefor, that the
final rule is being promulgated in response to an emergency that
makes timely compliance with such requirements impracticable. If the
agency has not prepared a final regulatory analysis within 180 days
from the date of publication of the final rule, the RFA provides
that the rule shall lapse and have no effect and shall not be re-
promulgated until a final regulatory flexibility analysis has been
completed by the agency. 5 U.S.C. 608(b).
---------------------------------------------------------------------------
This interim final rule establishes a regulatory mechanism for the
exercise of the PHS Act section 362 suspension authority, which
directly applies against persons and not State, local, or tribal
governments, or the private sector. Accordingly, HHS and CDC believe
that this interim final rule would likely impact only persons, and that
it would, therefore, not have a significant economic impact on a
substantial number of small entities. In addition, for the reasons set
forth in this document pertaining to the COVID-19 outbreak, the
Secretary finds that this interim final rule is being promulgated in
response to an emergency that makes timely compliance with the
provisions of section 604 impracticable. CDC will assess the potential
impacts--including economic effects--of this action on all small
entities. Based on that assessment, the Secretary will either certify
that the rule will not have a significant economic impact on a
substantial number of small entities or publish a final regulatory
flexibility analysis.
Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a
budgetary impact statement before promulgating a rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million in 1995 dollars, updated annually for inflation. Currently,
that threshold is approximately $154 million. If a
[[Page 16566]]
budgetary impact statement is required, section 205 of the Unfunded
Mandates Act also requires covered agencies to identify and consider a
reasonable number of regulatory alternatives before promulgating a
rule. HHS has determined that this interim final rule is not expected
to result in expenditures by State, local, and tribal governments, or
by the private sector, of $154 million or more in any one year because
it only establishes a regulatory mechanism for the exercise of the PHS
Act section 362 suspension authority, which applies against persons and
not State, local, or tribal governments, or the private sector.
Accordingly, HHS has not prepared a budgetary impact statement or
specifically addressed the regulatory alternatives considered.
National Environmental Policy Act (NEPA)
HHS has determined that the amendments to 42 CFR part 71 will not
have a significant impact on the human environment.
Executive Order 12988: Civil Justice Reform
HHS has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and has determined that this interim final rule meets
the standard in the Executive Order.
Executive Order 13132: Federalism
This interim final rule has been reviewed under Executive Order
13132, Federalism. Under 42 U.S.C. 264(e), Federal public health
regulations do not preempt State or local public health regulations,
except in the event of a conflict with the exercise of Federal
authority. Other than to restate this statutory provision, this
rulemaking does not alter the relationship between the Federal
government and State/local governments as set forth in 42 U.S.C. 264.
The longstanding provision on preemption in the event of a conflict
with Federal authority (42 CFR 70.2) is left unchanged by this
rulemaking. Furthermore, there are no provisions in this regulation
that impose direct compliance costs on State and local governments.
Therefore, HHS believes that the interim final rule does not warrant
additional analysis under Executive Order 13132.
Plain Language Act of 2010
Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13,
2010), executive Departments and Agencies are required to use plain
language in documents that explain to the public how to comply with a
requirement the Federal Government administers or enforces. HHS/CDC has
attempted to use plain language in promulgating this interim final
rule, consistent with the Federal Plain Writing Act guidelines.
Congressional Review Act
The Congressional Review Act defines a ``major rule'' as ``any rule
that the Administrator of the Office of Information and Regulatory
Affairs (OIRA) of the Office of Management and Budget finds has
resulted in or is likely to result in--(A) an annual effect on the
economy of $100,000,000 or more; (B) a major increase in costs or
prices for consumers, individual industries, Federal, State, or local
government agencies, or geographic regions; or (C) significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export
markets.'' 5 U.S.C. 804(2). This Office of Information and Regulatory
Affairs has determined that this interim final rule is a major rule for
purposes of the Congressional Review Act. As this rule is promulgated
under the ``good cause'' exemption of the Administrative Procedure Act,
there is not a delay in its effective date under the Congressional
Review Act.
Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999 requires Federal departments and agencies to determine
whether a proposed policy or regulation could affect family well-being.
If the determination is affirmative, then the Department or agency must
prepare an impact assessment to address criteria specified in the law.
HHS has determined that this interim final rule will not have an impact
on family well-being, as defined in the Act.
Paperwork Reduction Act of 1995
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
Ch. 3506; 5 CFR 1320 Appendix A.1), HHS has reviewed this interim final
rule and has determined that there are no new collections of
information contained therein.
List of Subjects in 42 CFR Part 71
Apprehension, Communicable diseases, Conditional release, CDC, Ill
person, Isolation, Non-invasive, Public health emergency, Public health
prevention measures, Qualifying stage, Quarantine, Quarantinable
communicable disease.
For the reasons set forth in the preamble, the Department of Health
and Human Services, on behalf of the Centers for Disease Control and
Prevention, amends 42 CFR part 71 as follows:
PART 71--FOREIGN QUARANTINE
0
1. The authority citation for part 71 continues to read as follows:
Authority: Secs. 215 and 311 of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as
amended (42 U.S.C. 264-272).
0
2. Add Sec. 71.40 to Subpart D of part 71 to read as follows:
Sec. 71.40 Prohibiting the introduction of persons from designated
foreign countries and places into the United States.
(a) The Director may prohibit the introduction into the United
States of persons from designated foreign countries (or one or more
political subdivisions and regions thereof) or places, only for such
period of time that the Director deems necessary for the public health,
by issuing an order in which the Director determines that:
(1) By reason of the existence of any communicable disease in a
foreign country (or one or more political subdivisions or regions
thereof) or place there is serious danger of the introduction of such
communicable disease into the United States; and
(2) This danger is so increased by the introduction of persons from
such country (or one or more political subdivisions or regions thereof)
or place that a suspension of the introduction of such persons into the
United States is required in the interest of the public health.
(b) For purposes of this section:
(1) Introduction into the United States of persons from a foreign
country (or one or more political subdivisions or regions thereof) or
place means the movement of a person from a foreign country (or one or
more political subdivisions or regions thereof) or place, or series of
foreign countries or places, into the United States so as to bring the
person into contact with persons in the United States, or so as to
cause the contamination of property in the United States, in a manner
that the Director determines to present a risk of transmission of a
communicable disease to persons or property, even if the communicable
disease has already been introduced, transmitted, or is spreading
within the United States;
(2) Serious danger of the introduction of such communicable disease
into the United States means the potential for introduction of vectors
of the
[[Page 16567]]
communicable disease into the United States, even if persons or
property in the United States are already infected or contaminated with
the communicable disease; and
(3) The term ``Place'' includes any location specified by the
Director, including any carrier, as that term is defined in 42 CFR
71.1, whatever the carrier's nationality.
(c) In any order issued under this section, the Director shall
designate the foreign countries (or one or more political subdivisions
or regions thereof) or places; the period of time or circumstances
under which the introduction of any persons or class of persons into
the United States shall be suspended; and the conditions under which
that prohibition on introduction, in whole or in part, shall be
effective, including any relevant exceptions that the Director
determines are appropriate.
(d) Before issuing any order under this section, the Director may
coordinate with State and local authorities and other Federal
departments or agencies as he deems appropriate in his discretion.
(1) If the order will be implemented in whole or in part by State
and local authorities who have agreed to do so under 42 U.S.C. 243(a),
then the Director may explain in the order the procedures and standards
by which those authorities are expected to aid in the enforcement of
the order.
(2) If the order will be implemented in whole or in part by
designated customs officers (including officers of the Department of
Homeland Security with U.S. Customs and Border Protection, who exercise
the authorities of customs officers) or Coast Guard officers under 42
U.S.C. 268(b), or another Federal department or agency, then the
Director shall, in coordination with the Secretary of Homeland Security
or other applicable Federal department or agency head, explain in the
order the procedures and standards by which any authorities or officers
or agents are expected to aid in the enforcement of the order, to the
extent that they are permitted to do so under their existing legal
authorities.
(e) This section does not apply to members of the armed forces of
the United States and associated personnel for whom the Secretary of
Defense provides assurance to the Director that the Secretary of
Defense, through measures such as quarantine, isolation, or other
measures maintaining control over such individuals, is preventing the
risk of transmission of a communicable disease into the United States.
(f) This section shall not apply to U.S. citizens and lawful
permanent residents.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-06238 Filed 3-20-20; 4:15 pm]
BILLING CODE 4163-18-P