[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: 
[email protected].

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