Extension of Order Under Sections 362 and 365 of the Public Health Service Act; Order Suspending Introduction of Certain Persons From Countries Where a Communicable Disease Exists, 22424-22427 [2020-08605]
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Federal Register / Vol. 85, No. 78 / Wednesday, April 22, 2020 / Notices
Scenario of El Paso Electric Company, et
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Filed Date: 4/15/20.
Accession Number: 20200415–5052.
Comments Due: 5 p.m. ET 5/6/20.
Take notice that the Commission
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Docket Numbers: ER10–3285–003;
ER10–3181–004; ER17–177–002; ER17–
991–008.
Applicants: UGI Utilities Inc., UGI
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Services, LLC, Hunlock Energy, LLC.
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2, 2019 Updated Triennial Market
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and Notice of Non-Material Change in
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Applicants: Mankato Energy Center II,
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Applicants: Northern Colorado Wind
Energy Center, LLC.
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Inc.
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3244R1 City of Malden ? Board of Public
Works NITSA NOA to be effective 4/1/
2020.
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Applicants: ITC Midwest LLC,
Interstate Power and Light Company.
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eFiling is encouraged. More detailed
information relating to filing
requirements, interventions, protests,
service, and qualifying facilities filings
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docs-filing/efiling/filing-req.pdf. For
other information, call (866) 208–3676
(toll free). For TTY, call (202) 502–8659.
Dated: April 15, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020–08442 Filed 4–21–20; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Extension of Order Under Sections 362
and 365 of the Public Health Service
Act; Order Suspending Introduction of
Certain Persons From Countries
Where a Communicable Disease Exists
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The Centers for Disease
Control and Prevention (CDC), a
component of the Department of Health
and Human Services (HHS), announces
an extension of an Order issued March
20, 2020, under Sections 362 and 365 of
the Public Health Service Act, and
associated implementing regulations,
that suspends the introduction of
certain persons from countries where an
outbreak of a communicable disease
exists. The Order was issued on April
20, 2020 and shall remain in effect until
11:59 p.m. EDT on May 20, 2020. This
Order may be amended or rescinded
prior to that time at the discretion of the
Director.
SUMMARY:
DATES:
This action took effect April 20,
2020.
Kyle
McGowan, Office of the Chief of Staff,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
V18–2, Atlanta, GA 30329. Phone: 404–
639–7000. Email: cdcregulations@
cdc.gov.
FOR FURTHER INFORMATION CONTACT:
On March
20, 2020, the Director of the Centers for
Disease Control and Prevention issued
an Order prohibiting the introduction of
certain persons from countries where an
outbreak of a communicable disease
exists (85 FR 17060; March 26, 2020).
SUPPLEMENTARY INFORMATION:
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The Order was scheduled to expire
April 20, 2020.1
Unfortunately, COVID–19 has
continued to spread since the March 20
Order. Canada and Mexico continue to
see large numbers of COVID–19
infections and deaths. In addition, the
United States has seen many states enter
the acceleration phase of the COVID–19
pandemic, which has strained the
healthcare system and prompted
dramatic public health responses at the
local, state, and Federal levels. Millions
of Americans are now complying with
local and state stay-at-home orders,
engaging in social distancing, and taking
other precautions calculated to slow the
spread of, and protect others from,
COVID–19. At the Federal level, HHS
and the Department of Homeland
Security (DHS) are working with public
and private stakeholders to rapidly
procure, distribute, and increase the
supply of scarce medical and healthcare
resources such as personal protective
equipment (PPE), ventilators, and
therapeutics for the American public.
The entire country has mobilized to
save lives by limiting face-to-face
contact and reserving medical and
healthcare resources for those who need
them most. The determinations made in
support of the March 20 Order remain
correct and should continue in place
until 11:59 p.m. EDT on May 20.
A copy of the order is provided below
and a copy of the signed order can be
found at https://www.cdc.gov/
quarantine/aboutlawsregulations
quarantineisolation.html.
U.S. Department of Health and Human
Services Centers for Disease Control
and Prevention (CDC)
Order Under Sections 362 & 365 of the
Public Health Service Act
(42 U.S.C. 265, 268):
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Extension of Order Suspending
Introduction of Certain Persons From
Countries Where a Communicable
Disease Exists
I am extending the Order Suspending
Introduction of Certain Persons from
Countries Where a Communicable
Disease Exists issued on March 20, 2020
until 11:59 p.m. EDT on May 20 or until
I determine that the danger of further
introduction of COVID–19 into the
United Sates has ceased to be a serious
danger to the public health, whichever
is sooner. I may further amend or extend
the March 20, 2020 Order as needed to
protect the public health.
1 See 1 CFR 18.17. When a date falls on a
weekend or holiday, the next Federal business day
is used.
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I issued the March 20, 2020 Order
pursuant to §§ 362 and 365 of the Public
Health Service (PHS) Act, 42 U.S.C. 265,
268, and the Act’s implementing
regulations, which authorize the
Director of the Centers for Disease
Control and Prevention (CDC) to
suspend the introduction of persons
into the United States when the Director
determines that the existence of a
communicable disease in a foreign
country or place creates a serious danger
of the introduction of such disease into
the United States, and the danger is so
increased by the introduction of persons
from the foreign country or place that a
temporary suspension of such
introduction is necessary to protect the
public health.
The March 20, 2020 Order suspended
introduction of certain ‘‘covered aliens’’
into the United States for a period of 30
days. The March 20, 2020 Order defined
‘‘covered aliens’’ as follows:
Persons traveling from Canada or Mexico
(regardless of their country of origin) who
would otherwise be introduced into a
congregate setting in a land Port of Entry
(‘‘POE’’) or Border Patrol station at or near
the United States border with Canada or
Mexico, subject to exceptions. This order
does not apply to U.S. citizens, lawful
permanent residents, and their spouses and
children; members of the armed forces of the
United States, and associated personnel, and
their spouses and children; persons from
foreign countries who hold valid travel
documents and arrive at a POE; or persons
from foreign countries in the visa waiver
program who are not otherwise subject to
travel restrictions and arrive at a POE.
In addition, the March 20, 2020 Order
did not apply to ‘‘persons whom
customs officers of DHS determine, with
approval from a supervisor, should be
excepted based on the totality of the
circumstances, including consideration
of significant law enforcement, officer
and public safety, humanitarian, and
public health interests.’’
The March 20, 2020 Order was based
on the following determinations:
• COVID–19 is a communicable
disease that poses a danger to the public
health;
• COVID–19 is present in numerous
foreign countries, including Canada and
Mexico;
• There is a serious danger of the
introduction of COVID–19 into the land
POEs and Border Patrol stations at or
near the United States borders with
Canada and Mexico, and into the
interior of the country as a whole,
because COVID–19 exists in Canada,
Mexico, and the other countries of
origin of persons who migrate to the
United States across the land borders
with Canada and Mexico;
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• But for a suspension-of-entry order
under 42 U.S.C. 265, covered aliens
would be subject to immigration
processing at the land POEs and Border
Patrol stations, and during that
processing many of them (typically
aliens who lack valid travel documents
and are therefore inadmissible) would
be held in the common areas of the
facilities, in close proximity to one
another, for hours or days; and
• Such introduction into congregate
settings of persons from Canada or
Mexico would increase the already
serious danger to the public health to
the point of requiring a temporary
suspension of the introduction of
covered aliens into the United States.
COVID–19 has continued to spread
since the March 20, 2020 Order. Canada
and Mexico continue to see increasing
numbers of COVID–19 infections and
deaths. In addition, the United States
has seen many states experience
exponential growth in the number of
confirmed COVID–19 cases, which has
strained the healthcare system and
prompted dramatic public health
responses at the local, state, and Federal
levels. Millions of Americans are now
complying with local and state stay-athome orders, engaging in social
distancing, and taking other precautions
calculated to slow the spread of, and
protect others from, COVID–19. At the
Federal level, the U.S. Departments of
Health and Human Services (HHS) and
Homeland Security (DHS) are working
with public and private stakeholders to
rapidly procure, distribute, and increase
the supply of scarce medical and
healthcare resources such as personal
protective equipment (PPE), ventilators,
and therapeutics for the American
public. The entire country has
mobilized to save lives by limiting faceto-face contact and reserving medical
and healthcare resources for those who
need them most. At a time when these
domestic efforts are ongoing and
effective, it would be counterproductive
and dangerous to undermine those
efforts by permitting the introduction of
persons from outside the United States
who pose a risk of transmission of
COVID–19 within DHS facilities or the
U.S. interior.
Further, the determinations made in
support of the March 20, 2020 Order
remain correct. If anything, they have
become more compelling. I therefore
conclude that the March 20, 2020 Order
should remain in effect until 11:59 p.m.
EDT on May 20.
COVID–19 Is Continuing To Spread in
Canada, Mexico, and the United States
Since the March 20, 2020 Order, the
number of COVID–19 cases globally,
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including in Canada, Mexico, and the
United States, has continued to
increase.
Canada
As of April 13, 2020, Canada has
reported 24,804 confirmed cases of
COVID–19, and a total of 734 deaths.
Canada has tested 422,200 people for
COVID–19.2 The Public Health Agency
of Canada estimates that 72% of
infections are the result of community
transmission. Canadian modeling
indicates that, with the use of strong
epidemic controls resulting in a 2.5%
infection rate, Canada could see 940,000
people with infections, 73,000
hospitalizations, and 23,000 people
requiring intensive care over the course
of the COVID–19 pandemic.3
Canada has implemented and
maintained robust public health
measures to slow the spread of COVID–
19, including closures of public schools
and cancelation of public events.4 Nonessential businesses have been closed
across the country.
Mexico
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As of April 12, 2020, Mexico has
reported 3,844 confirmed cases of
COVID–19 and 233 deaths.5
Nevertheless, based on public health
surveillance, Mexico estimates that its
current case count is 26,519. Mexico’s
modeling, based on World Health
Organization (WHO) reporting from
China, assumes a 0.2% infection rate
with 250,656 infected people during the
acceleration phase of the pandemic.6 Of
those people, 70% (175,459) are
2 Government of Canada, Coronavirus disease
(COVID–19): Outbreak Update (Apr. 13, 2020),
https://www.canada.ca/en/public-health/services/
diseases/2019-novel-coronavirusinfection.html?topic=tilelink#a2.
3 Public Health Agency of Canada, COVID–19 in
Canada: Using Data and Modeling to Inform Public
Health Action (Apr. 9, 2020), available at https://
www.canada.ca/content/dam/phac-aspc/
documents/services/diseases/2019-novelcoronavirus-infection/using-data-modelling-informeng.pdf.
4 See generally Kristin Rushowy, The Star,
Ontario Schools Will Remain Closed Until at Least
May 4. But Kids Can Expect Marks (Mar. 31, 2020),
https://www.thestar.com/politics/provincial/2020/
03/31/ontario-schools-wont-open-until-at-leastmay.html; Ryan Rocca, Global News, Coronavirus:
City of Toronto Cancels Events Through June 30,
including Pride Parade (updated Apr. 1, 2020),
https://globalnews.ca/news/6758350/coronavirustoronto-cancels-events-pride-parade/.
5 World Health Organization, Coronavirus Disease
2019 (COVID–19) Situation Report—83 (Apr. 12,
2020), https://www.who.int/docs/default-source/
coronaviruse/situation-reports/20200412-sitrep-83covid-19.pdf?sfvrsn= 697ce98d_4.
6 Secretaria De Salud, COVID–19: Comunicado
Tecnico Diario (Mar. 17, 2020), available at https://
www.gob.mx/cms/uploads/attachment/file/541879/
COVID-19_-_Presentacion_Comunicado_Tecnico_
Diario_2020.03.17.pdf.pdf.
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anticipated to seek medical care.7
Among people seeking medical care, it
is projected that 80% (140,367) will be
ambulatory patients, 14% (25,564) will
need to be hospitalized without
intensive care, and 6% (10,528) will
require intensive care.8
On March 30, 2020, Mexico’s General
Health Council declared a ‘‘State of
Health Emergency’’ and suspended all
non-essential activities in the public
and private sectors until April 30,
2020.9 The order granted full authority
to the Secretariat of Health to take
action to address the pandemic across
Mexico. The central guidance of the
Mexican health authorities is to
maximize social distancing and that
people should only leave their homes
for essential activities, such as to
procure food or medical care.10 State
and local authorities in several Mexican
states also are enforcing non-essential
business closures and self-quarantine
measures.
United States
As of April 13, 2020, the United
States has reported 554,849 confirmed
cases of COVID–19 across the United
States and 21,942 deaths.11 Community
transmission of COVID–19 is occurring
in many locations across the United
States. Several cities and states have
experienced widespread, sustained
community transmission to the extent
that their healthcare and public health
systems are at risk of being
overwhelmed. This includes parts of
states and territories at or near borders
of the United States which are reporting
large increases in new COVID–19 cases
since the March 20, 2020 Order.12
In addition to practicing rigorous
hygiene and social distancing and
limiting non-essential travel,13 CDC’s
guidance to the general public has
expanded to include the
recommendation that individuals wear
7 Id.
8 Id.
9 U.S.
Department of State, U.S. Embassy and
Consulates in Mexico, Health Alert—Mexico
COVID–19 Update (Apr. 10, 2020), https://
mx.usembassy.gov/health-alert-mexico-covid-19update-04-10-2020/.
10 Id.
11 CDC, Cases in U.S. (updated Apr. 13, 2020),
https://www.cdc.gov/coronavirus/2019-ncov/casesupdates/cases-in-us.html.
12 The New York Times, Coronavirus in the U.S.:
Latest Map and Case Count (Apr. 13, 2020), https://
www.nytimes.com/interactive/2020/us/coronavirusus-cases.html#states; see also CDC, Coronavirus
Disease 2019 (COVID–19): Cases in U.S.: States
Reporting Cases of COVID–19 to CDC (Apr. 14,
2020), https://www.cdc.gov/coronavirus/2019-ncov/
cases-updates/cases-in-us.html#cumulative.
13 CDC, COVID–19: How to Protect Yourself and
Others (last reviewed Apr. 8, 2020), https://
www.cdc.gov/coronavirus/2019-ncov/preventgetting-sick/prevention.html.
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face coverings when out in public.14
CDC expects widespread transmission
of COVID–19 in the United States will
occur and, in the coming months, most
of the U.S. will be exposed to COVID–
19.15 Nevertheless, not all areas of the
United States are currently experiencing
high rates of infection or numbers of
confirmed cases. Generally speaking,
COVID–19 is currently concentrated
along the East, West, and Gulf Coasts
and in the Great Lakes region; there are
significantly fewer cases in the interior
of the United States.16 Limiting the
spread of COVID–19 in these less
affected areas is a critical component of
the overall U.S. strategy to ‘‘flatten the
curve,’’ which requires limiting the
number of foci, or infected individuals,
who may enter these areas.
Joint Efforts
On March 20, 2020, the United States
and Canada jointly decided to restrict
all non-essential travel across the U.S.Canadian border for 30 days, with
limited exceptions for U.S. citizens and
others entering Canada for essential
business, provided these individuals
have not been outside Canada or the
United States in the 14 days prior to
requesting entry into Canada. Foreign
nationals, excluding those arriving from
the U.S., will not be allowed into
Canada, subject to certain exceptions.17
The Canadian government is requiring
individuals returning home to Canada to
self-isolate for 14 days upon their
return.18 Individuals exhibiting
symptoms of COVID–19 are not
permitted to enter Canada, except for
Canadian citizens or permanent
residents.19
Similarly, on March 20, 2020, the
United States and Mexico announced a
joint initiative temporarily restricting all
non-essential travel across their border
in an effort to combat the spread of
COVID–19.20
14 CDC, COVID–19: How to Wear a Cloth Face
Covering (last reviewed Apr. 9, 2020), https://
www.cdc.gov/coronavirus/2019-ncov/preventgetting-sick/diy-cloth-face-coverings.html.
15 CDC, Testing for COVID–19 (Mar. 21, 2020),
https://www.cdc.gov/coronavirus/2019-ncov/
symptoms-testing/testing.html.
16 See Johns Hopkins University, COVID–19
United States Cases by County, https://
coronavirus.jhu.edu/us-map.
17 See Notification of Temporary Travel
Restrictions Applicable to Land Ports of Entry and
Ferries Service Between the United States and
Canada, 85 FR 16548 (Mar. 24, 2020).
18 Government of Canada, Coronavirus disease
(COVID–19): Canada’s Response, https://
www.canada.ca/en/public-health/services/diseases/
2019-novel-coronavirus-infection/canadasreponse.html?topic=tilelink.
19 Id.
20 U.S. Department of Homeland Security, Joint
Statement on U.S.-Mexico Joint Initiative to Combat
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Availability of Rapid COVID–19 Testing
Since the March 20, 2020 Order, rapid
testing for COVID–19 has been
developed that can provide results in
approximately 15 minutes and
manufacturers are currently ramping up
production and distribution of rapid
COVID–19 testing.21 Although rapid
COVID–19 testing could ameliorate
some of the public health concerns
associated with congregate detention in
DHS border facilities, rapid COVID–19
testing is not yet widely available, and
demand outstrips supply. Moreover,
once it is available, rapid COVID–19
testing should be prioritized to certain
key locations, such as hospitals treating
high numbers of COVID–19 patients,
where the ability to quickly determine
whether doctors and nurses have been
infected with COVID–19 could increase
the availability of care providers by
eliminating the need for these
individuals to self-isolate while
awaiting test results.
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Determination and Implementation
Based on the foregoing, I find that the
global presence of COVID–19, including
in Canada, Mexico, still presents a
danger of further introduction of
COVID–19 into the United States. This
is true notwithstanding the community
transmission of COVID–19 in many
locations across the United States. There
are many locations in the United States
the COVID–19 Pandemic (Mar. 20, 2020), available
at https://www.dhs.gov/news/2020/03/20/jointstatement-us-mexico-joint-initiative-combat-covid19-pandemic.
21 For instance, on March 27, 2020, Abbott
received emergency use authorization from the U.S.
Food and Drug Administration (‘‘FDA’’) for the
fastest available point-of-care test for COVID–19.
Abbott, ‘‘Detect COVID–19 in as Little as 5
Minutes’’ (Mar. 27, 2020), https://www.abbott.com/
corpnewsroom/product-and-innovation/detectcovid-19-in-as-little-as-5-minutes.html; see
generally U.S. Food and Drug Administration,
Emergency Use Authorizations, https://
www.fda.gov/medical-devices/emergencysituations-medical-devices/emergency-useauthorizations#covid19ivd. Rapid COVID–19
testing will significantly reduce the time needed to
confirm a suspected diagnosis of COVID–19, which
currently may take as long as three to four days. See
CDC, Order Suspending Introduction of Certain
Persons from Countries where a Communicable
Disease Exists (Mar. 20, 2020), available at https://
www.cdc.gov/quarantine/pdf/CDC-OrderProhibiting-Introduction-of-Persons_Final_3-20-20_
3-p.pdf; see also CDC, Interim Guidelines for
Collecting, Handling, and Testing Clinical
Specimens from Persons for Coronavirus Disease
2019 (COVID–19) (updated Apr. 8, 2020), https://
www.cdc.gov/coronavirus/2019-nCoV/lab/
guidelines-clinical-specimens.html. When a case of
COVID–19 is suspected, the sooner that
confirmatory test results are available, the more
quickly treatment and isolation and quarantine
measures can be implemented, lowering the risk of
infecting others. See CDC, Evaluating and Testing
Persons for Coronavirus Disease 2019 (COVID–19)
(updated Mar. 24, 2020), https://www.cdc.gov/
coronavirus/2019-nCoV/hcp/clinical-criteria.html.
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near our borders with Canada and
Mexico that have not yet experienced
widespread community transmission.
The on-going COVID–19 pandemic,
including in Canada and Mexico,
remains a serious danger to such
locations.
In the March 20, 2020 Order, I found
the risks troubling partly because
outbreaks of COVID–19 in POEs or
Border Patrol stations would lead U.S.
Customs and Border Protection to
transfer persons with acute
presentations of illness to local or
regional healthcare providers for
treatment, which would exhaust the
local or regional healthcare resources or
at least reduce the availability of such
resources to the domestic population,
and further expose local or regional
healthcare workers to COVID–19.
Millions of Americans are complying
with local and state stay-at-home orders,
engaging in social distancing, and taking
other precautions calculated to slow the
spread, protect others, and relieve the
strain on the healthcare system. Their
efforts would be significantly
undermined if outbreaks of COVID–19
in land POEs or Border Patrol stations
crippled the DHS workforce and local or
regional healthcare systems.
I consulted with DHS before issuing
this Order and requested that DHS
continue to implement the March 20,
2020 Order because CDC does not have
the capability, resources, or personnel
needed to alternatively issue quarantine
or isolation orders.22
The March 20, 2020 Order shall
remain in effect until 11:59 p.m. EDT on
May 20, or until I determine that the
danger of further introduction of
COVID–19 into the United Sates has
ceased to be a serious danger to the
public health, whichever is sooner. I
may further amend or extend the March
20, 2020 Order as needed to protect the
public health.
This Order is not a rule subject to
notice and comment under the
Administrative Procedure Act (APA). In
the event this order qualifies as a rule
subject to notice and comment, a delay
in effective date are not required
because there is good cause to dispense
with prior public notice and the
22 As previously discussed in the March 20, 2020
Order, CDC relies on the Department of Defense,
other federal agencies, and state and local
governments to provide both logistical support and
facilities for federal quarantines. See 42 U.S.C.
268(b) (requiring customs officers to aid in the
enforcement of quarantine regulations). CDC lacks
the resources, staffing, and facilities to quarantine
covered aliens. Similarly, DHS has informed CDC
that in the near term, it is not financially or
logistically practicable for DHS to build additional
facilities at POEs and Border Patrol stations for
purposes of quarantine or isolation.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
22427
opportunity to comment on this order
and a delay in effective date.23 Given
the public health emergency caused by
COVID–19, it would be impracticable
and contrary to the public health—and,
by extension, the public interest—to
delay the issuing and effective date of
this order. In addition, because this
order concerns ongoing discussions
with Canada and Mexico on how to best
control COVID–19 transmission over
our shared borders, it directly
‘‘involve[s] . . . a . . . foreign affairs
function of the United States.’’ 5 U.S.C.
553(a)(1). Notice and comment and a
delay in effective date would not be
required for that reason as well.
*
*
*
*
*
The March 20, 2020 Order shall
remain in effect until 11:59 p.m. EDT on
May 20, 2020.
Authority
The authority for these orders is
Sections 362 and 365 of the Public
Health Service Act (42 U.S.C. 265, 268)
and 42 CFR 71.40.
Dated: April 19, 2020.
Robert K. McGowan,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2020–08605 Filed 4–20–20; 9:00 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5573]
Technical Considerations for
Demonstrating Reliability of
Emergency-Use Injectors Submitted
Under a Biologics License Application,
New Drug Application, or Abbreviated
New Drug Application; Draft Guidance
for Industry and Food and Drug
Administration; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry and FDA entitled
‘‘Technical Considerations for
Demonstrating Reliability of EmergencyUse Injectors Submitted under a BLA,
NDA or ANDA.’’ For injectable drug or
biological products that are intended to
treat emergent, life-threatening
conditions, it is essential to ensure that
the emergency-use injector will reliably
deliver the drug or biological product as
SUMMARY:
23 See
E:\FR\FM\22APN1.SGM
5 U.S.C. 553(b)(B) and (d)(3).
22APN1
Agencies
[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Notices]
[Pages 22424-22427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08605]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Extension of Order Under Sections 362 and 365 of the Public
Health Service Act; Order Suspending Introduction of Certain Persons
From Countries Where a Communicable Disease Exists
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), a
component of the Department of Health and Human Services (HHS),
announces an extension of an Order issued March 20, 2020, under
Sections 362 and 365 of the Public Health Service Act, and associated
implementing regulations, that suspends the introduction of certain
persons from countries where an outbreak of a communicable disease
exists. The Order was issued on April 20, 2020 and shall remain in
effect until 11:59 p.m. EDT on May 20, 2020. This Order may be amended
or rescinded prior to that time at the discretion of the Director.
DATES: This action took effect April 20, 2020.
FOR FURTHER INFORMATION CONTACT: Kyle McGowan, Office of the Chief of
Staff, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS V18-2, Atlanta, GA 30329. Phone: 404-639-7000. Email:
[email protected].
SUPPLEMENTARY INFORMATION: On March 20, 2020, the Director of the
Centers for Disease Control and Prevention issued an Order prohibiting
the introduction of certain persons from countries where an outbreak of
a communicable disease exists (85 FR 17060; March 26, 2020).
[[Page 22425]]
The Order was scheduled to expire April 20, 2020.\1\
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\1\ See 1 CFR 18.17. When a date falls on a weekend or holiday,
the next Federal business day is used.
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Unfortunately, COVID-19 has continued to spread since the March 20
Order. Canada and Mexico continue to see large numbers of COVID-19
infections and deaths. In addition, the United States has seen many
states enter the acceleration phase of the COVID-19 pandemic, which has
strained the healthcare system and prompted dramatic public health
responses at the local, state, and Federal levels. Millions of
Americans are now complying with local and state stay-at-home orders,
engaging in social distancing, and taking other precautions calculated
to slow the spread of, and protect others from, COVID-19. At the
Federal level, HHS and the Department of Homeland Security (DHS) are
working with public and private stakeholders to rapidly procure,
distribute, and increase the supply of scarce medical and healthcare
resources such as personal protective equipment (PPE), ventilators, and
therapeutics for the American public. The entire country has mobilized
to save lives by limiting face-to-face contact and reserving medical
and healthcare resources for those who need them most. The
determinations made in support of the March 20 Order remain correct and
should continue in place until 11:59 p.m. EDT on May 20.
A copy of the order is provided below and a copy of the signed
order can be found at https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html.
U.S. Department of Health and Human Services Centers for Disease
Control and Prevention (CDC)
Order Under Sections 362 & 365 of the Public Health Service Act
(42 U.S.C. 265, 268):
Extension of Order Suspending Introduction of Certain Persons From
Countries Where a Communicable Disease Exists
I am extending the Order Suspending Introduction of Certain Persons
from Countries Where a Communicable Disease Exists issued on March 20,
2020 until 11:59 p.m. EDT on May 20 or until I determine that the
danger of further introduction of COVID-19 into the United Sates has
ceased to be a serious danger to the public health, whichever is
sooner. I may further amend or extend the March 20, 2020 Order as
needed to protect the public health.
I issued the March 20, 2020 Order pursuant to Sec. Sec. 362 and
365 of the Public Health Service (PHS) Act, 42 U.S.C. 265, 268, and the
Act's implementing regulations, which authorize the Director of the
Centers for Disease Control and Prevention (CDC) to suspend the
introduction of persons into the United States when the Director
determines that the existence of a communicable disease in a foreign
country or place creates a serious danger of the introduction of such
disease into the United States, and the danger is so increased by the
introduction of persons from the foreign country or place that a
temporary suspension of such introduction is necessary to protect the
public health.
The March 20, 2020 Order suspended introduction of certain
``covered aliens'' into the United States for a period of 30 days. The
March 20, 2020 Order defined ``covered aliens'' as follows:
Persons traveling from Canada or Mexico (regardless of their
country of origin) who would otherwise be introduced into a
congregate setting in a land Port of Entry (``POE'') or Border
Patrol station at or near the United States border with Canada or
Mexico, subject to exceptions. This order does not apply to U.S.
citizens, lawful permanent residents, and their spouses and
children; members of the armed forces of the United States, and
associated personnel, and their spouses and children; persons from
foreign countries who hold valid travel documents and arrive at a
POE; or persons from foreign countries in the visa waiver program
who are not otherwise subject to travel restrictions and arrive at a
POE.
In addition, the March 20, 2020 Order did not apply to ``persons whom
customs officers of DHS determine, with approval from a supervisor,
should be excepted based on the totality of the circumstances,
including consideration of significant law enforcement, officer and
public safety, humanitarian, and public health interests.''
The March 20, 2020 Order was based on the following determinations:
COVID-19 is a communicable disease that poses a danger to
the public health;
COVID-19 is present in numerous foreign countries,
including Canada and Mexico;
There is a serious danger of the introduction of COVID-19
into the land POEs and Border Patrol stations at or near the United
States borders with Canada and Mexico, and into the interior of the
country as a whole, because COVID-19 exists in Canada, Mexico, and the
other countries of origin of persons who migrate to the United States
across the land borders with Canada and Mexico;
But for a suspension-of-entry order under 42 U.S.C. 265,
covered aliens would be subject to immigration processing at the land
POEs and Border Patrol stations, and during that processing many of
them (typically aliens who lack valid travel documents and are
therefore inadmissible) would be held in the common areas of the
facilities, in close proximity to one another, for hours or days; and
Such introduction into congregate settings of persons from
Canada or Mexico would increase the already serious danger to the
public health to the point of requiring a temporary suspension of the
introduction of covered aliens into the United States.
COVID-19 has continued to spread since the March 20, 2020 Order.
Canada and Mexico continue to see increasing numbers of COVID-19
infections and deaths. In addition, the United States has seen many
states experience exponential growth in the number of confirmed COVID-
19 cases, which has strained the healthcare system and prompted
dramatic public health responses at the local, state, and Federal
levels. Millions of Americans are now complying with local and state
stay-at-home orders, engaging in social distancing, and taking other
precautions calculated to slow the spread of, and protect others from,
COVID-19. At the Federal level, the U.S. Departments of Health and
Human Services (HHS) and Homeland Security (DHS) are working with
public and private stakeholders to rapidly procure, distribute, and
increase the supply of scarce medical and healthcare resources such as
personal protective equipment (PPE), ventilators, and therapeutics for
the American public. The entire country has mobilized to save lives by
limiting face-to-face contact and reserving medical and healthcare
resources for those who need them most. At a time when these domestic
efforts are ongoing and effective, it would be counterproductive and
dangerous to undermine those efforts by permitting the introduction of
persons from outside the United States who pose a risk of transmission
of COVID-19 within DHS facilities or the U.S. interior.
Further, the determinations made in support of the March 20, 2020
Order remain correct. If anything, they have become more compelling. I
therefore conclude that the March 20, 2020 Order should remain in
effect until 11:59 p.m. EDT on May 20.
COVID-19 Is Continuing To Spread in Canada, Mexico, and the United
States
Since the March 20, 2020 Order, the number of COVID-19 cases
globally,
[[Page 22426]]
including in Canada, Mexico, and the United States, has continued to
increase.
Canada
As of April 13, 2020, Canada has reported 24,804 confirmed cases of
COVID-19, and a total of 734 deaths. Canada has tested 422,200 people
for COVID-19.\2\ The Public Health Agency of Canada estimates that 72%
of infections are the result of community transmission. Canadian
modeling indicates that, with the use of strong epidemic controls
resulting in a 2.5% infection rate, Canada could see 940,000 people
with infections, 73,000 hospitalizations, and 23,000 people requiring
intensive care over the course of the COVID-19 pandemic.\3\
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\2\ Government of Canada, Coronavirus disease (COVID-19):
Outbreak Update (Apr. 13, 2020), https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection.html?topic=tilelink#a2.
\3\ Public Health Agency of Canada, COVID-19 in Canada: Using
Data and Modeling to Inform Public Health Action (Apr. 9, 2020),
available at https://www.canada.ca/content/dam/phac-aspc/documents/services/diseases/2019-novel-coronavirus-infection/using-data-modelling-inform-eng.pdf.
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Canada has implemented and maintained robust public health measures
to slow the spread of COVID-19, including closures of public schools
and cancelation of public events.\4\ Non-essential businesses have been
closed across the country.
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\4\ See generally Kristin Rushowy, The Star, Ontario Schools
Will Remain Closed Until at Least May 4. But Kids Can Expect Marks
(Mar. 31, 2020), https://www.thestar.com/politics/provincial/2020/03/31/ontario-schools-wont-open-until-at-least-may.html; Ryan Rocca,
Global News, Coronavirus: City of Toronto Cancels Events Through
June 30, including Pride Parade (updated Apr. 1, 2020), https://globalnews.ca/news/6758350/coronavirus-toronto-cancels-events-pride-parade/.
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Mexico
As of April 12, 2020, Mexico has reported 3,844 confirmed cases of
COVID-19 and 233 deaths.\5\ Nevertheless, based on public health
surveillance, Mexico estimates that its current case count is 26,519.
Mexico's modeling, based on World Health Organization (WHO) reporting
from China, assumes a 0.2% infection rate with 250,656 infected people
during the acceleration phase of the pandemic.\6\ Of those people, 70%
(175,459) are anticipated to seek medical care.\7\ Among people seeking
medical care, it is projected that 80% (140,367) will be ambulatory
patients, 14% (25,564) will need to be hospitalized without intensive
care, and 6% (10,528) will require intensive care.\8\
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\5\ World Health Organization, Coronavirus Disease 2019 (COVID-
19) Situation Report--83 (Apr. 12, 2020), https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200412-sitrep-83-covid-19.pdf?sfvrsn= 697ce98d_4.
\6\ Secretaria De Salud, COVID-19: Comunicado Tecnico Diario
(Mar. 17, 2020), available at https://www.gob.mx/cms/uploads/attachment/file/541879/COVID-19_-_Presentacion_Comunicado_Tecnico_Diario_2020.03.17.pdf.pdf.
\7\ Id.
\8\ Id.
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On March 30, 2020, Mexico's General Health Council declared a
``State of Health Emergency'' and suspended all non-essential
activities in the public and private sectors until April 30, 2020.\9\
The order granted full authority to the Secretariat of Health to take
action to address the pandemic across Mexico. The central guidance of
the Mexican health authorities is to maximize social distancing and
that people should only leave their homes for essential activities,
such as to procure food or medical care.\10\ State and local
authorities in several Mexican states also are enforcing non-essential
business closures and self-quarantine measures.
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\9\ U.S. Department of State, U.S. Embassy and Consulates in
Mexico, Health Alert--Mexico COVID-19 Update (Apr. 10, 2020),
https://mx.usembassy.gov/health-alert-mexico-covid-19-update-04-10-2020/.
\10\ Id.
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United States
As of April 13, 2020, the United States has reported 554,849
confirmed cases of COVID-19 across the United States and 21,942
deaths.\11\ Community transmission of COVID-19 is occurring in many
locations across the United States. Several cities and states have
experienced widespread, sustained community transmission to the extent
that their healthcare and public health systems are at risk of being
overwhelmed. This includes parts of states and territories at or near
borders of the United States which are reporting large increases in new
COVID-19 cases since the March 20, 2020 Order.\12\
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\11\ CDC, Cases in U.S. (updated Apr. 13, 2020), https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
\12\ The New York Times, Coronavirus in the U.S.: Latest Map and
Case Count (Apr. 13, 2020), https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html#states; see also CDC, Coronavirus
Disease 2019 (COVID-19): Cases in U.S.: States Reporting Cases of
COVID-19 to CDC (Apr. 14, 2020), https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html#cumulative.
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In addition to practicing rigorous hygiene and social distancing
and limiting non-essential travel,\13\ CDC's guidance to the general
public has expanded to include the recommendation that individuals wear
face coverings when out in public.\14\ CDC expects widespread
transmission of COVID-19 in the United States will occur and, in the
coming months, most of the U.S. will be exposed to COVID-19.\15\
Nevertheless, not all areas of the United States are currently
experiencing high rates of infection or numbers of confirmed cases.
Generally speaking, COVID-19 is currently concentrated along the East,
West, and Gulf Coasts and in the Great Lakes region; there are
significantly fewer cases in the interior of the United States.\16\
Limiting the spread of COVID-19 in these less affected areas is a
critical component of the overall U.S. strategy to ``flatten the
curve,'' which requires limiting the number of foci, or infected
individuals, who may enter these areas.
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\13\ CDC, COVID-19: How to Protect Yourself and Others (last
reviewed Apr. 8, 2020), https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
\14\ CDC, COVID-19: How to Wear a Cloth Face Covering (last
reviewed Apr. 9, 2020), https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html.
\15\ CDC, Testing for COVID-19 (Mar. 21, 2020), https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html.
\16\ See Johns Hopkins University, COVID-19 United States Cases
by County, https://coronavirus.jhu.edu/us-map.
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Joint Efforts
On March 20, 2020, the United States and Canada jointly decided to
restrict all non-essential travel across the U.S.-Canadian border for
30 days, with limited exceptions for U.S. citizens and others entering
Canada for essential business, provided these individuals have not been
outside Canada or the United States in the 14 days prior to requesting
entry into Canada. Foreign nationals, excluding those arriving from the
U.S., will not be allowed into Canada, subject to certain
exceptions.\17\ The Canadian government is requiring individuals
returning home to Canada to self-isolate for 14 days upon their
return.\18\ Individuals exhibiting symptoms of COVID-19 are not
permitted to enter Canada, except for Canadian citizens or permanent
residents.\19\
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\17\ See Notification of Temporary Travel Restrictions
Applicable to Land Ports of Entry and Ferries Service Between the
United States and Canada, 85 FR 16548 (Mar. 24, 2020).
\18\ Government of Canada, Coronavirus disease (COVID-19):
Canada's Response, https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/canadas-reponse.html?topic=tilelink.
\19\ Id.
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Similarly, on March 20, 2020, the United States and Mexico
announced a joint initiative temporarily restricting all non-essential
travel across their border in an effort to combat the spread of COVID-
19.\20\
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\20\ U.S. Department of Homeland Security, Joint Statement on
U.S.-Mexico Joint Initiative to Combat the COVID-19 Pandemic (Mar.
20, 2020), available at https://www.dhs.gov/news/2020/03/20/joint-statement-us-mexico-joint-initiative-combat-covid-19-pandemic.
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[[Page 22427]]
Availability of Rapid COVID-19 Testing
Since the March 20, 2020 Order, rapid testing for COVID-19 has been
developed that can provide results in approximately 15 minutes and
manufacturers are currently ramping up production and distribution of
rapid COVID-19 testing.\21\ Although rapid COVID-19 testing could
ameliorate some of the public health concerns associated with
congregate detention in DHS border facilities, rapid COVID-19 testing
is not yet widely available, and demand outstrips supply. Moreover,
once it is available, rapid COVID-19 testing should be prioritized to
certain key locations, such as hospitals treating high numbers of
COVID-19 patients, where the ability to quickly determine whether
doctors and nurses have been infected with COVID-19 could increase the
availability of care providers by eliminating the need for these
individuals to self-isolate while awaiting test results.
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\21\ For instance, on March 27, 2020, Abbott received emergency
use authorization from the U.S. Food and Drug Administration
(``FDA'') for the fastest available point-of-care test for COVID-19.
Abbott, ``Detect COVID-19 in as Little as 5 Minutes'' (Mar. 27,
2020), https://www.abbott.com/corpnewsroom/product-and-innovation/detect-covid-19-in-as-little-as-5-minutes.html; see generally U.S.
Food and Drug Administration, Emergency Use Authorizations, https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd. Rapid COVID-19 testing will
significantly reduce the time needed to confirm a suspected
diagnosis of COVID-19, which currently may take as long as three to
four days. See CDC, Order Suspending Introduction of Certain Persons
from Countries where a Communicable Disease Exists (Mar. 20, 2020),
available at https://www.cdc.gov/quarantine/pdf/CDC-Order-Prohibiting-Introduction-of-Persons_Final_3-20-20_3-p.pdf; see also
CDC, Interim Guidelines for Collecting, Handling, and Testing
Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-
19) (updated Apr. 8, 2020), https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html. When a case of COVID-19
is suspected, the sooner that confirmatory test results are
available, the more quickly treatment and isolation and quarantine
measures can be implemented, lowering the risk of infecting others.
See CDC, Evaluating and Testing Persons for Coronavirus Disease 2019
(COVID-19) (updated Mar. 24, 2020), https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html.
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Determination and Implementation
Based on the foregoing, I find that the global presence of COVID-
19, including in Canada, Mexico, still presents a danger of further
introduction of COVID-19 into the United States. This is true
notwithstanding the community transmission of COVID-19 in many
locations across the United States. There are many locations in the
United States near our borders with Canada and Mexico that have not yet
experienced widespread community transmission. The on-going COVID-19
pandemic, including in Canada and Mexico, remains a serious danger to
such locations.
In the March 20, 2020 Order, I found the risks troubling partly
because outbreaks of COVID-19 in POEs or Border Patrol stations would
lead U.S. Customs and Border Protection to transfer persons with acute
presentations of illness to local or regional healthcare providers for
treatment, which would exhaust the local or regional healthcare
resources or at least reduce the availability of such resources to the
domestic population, and further expose local or regional healthcare
workers to COVID-19. Millions of Americans are complying with local and
state stay-at-home orders, engaging in social distancing, and taking
other precautions calculated to slow the spread, protect others, and
relieve the strain on the healthcare system. Their efforts would be
significantly undermined if outbreaks of COVID-19 in land POEs or
Border Patrol stations crippled the DHS workforce and local or regional
healthcare systems.
I consulted with DHS before issuing this Order and requested that
DHS continue to implement the March 20, 2020 Order because CDC does not
have the capability, resources, or personnel needed to alternatively
issue quarantine or isolation orders.\22\
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\22\ As previously discussed in the March 20, 2020 Order, CDC
relies on the Department of Defense, other federal agencies, and
state and local governments to provide both logistical support and
facilities for federal quarantines. See 42 U.S.C. 268(b) (requiring
customs officers to aid in the enforcement of quarantine
regulations). CDC lacks the resources, staffing, and facilities to
quarantine covered aliens. Similarly, DHS has informed CDC that in
the near term, it is not financially or logistically practicable for
DHS to build additional facilities at POEs and Border Patrol
stations for purposes of quarantine or isolation.
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The March 20, 2020 Order shall remain in effect until 11:59 p.m.
EDT on May 20, or until I determine that the danger of further
introduction of COVID-19 into the United Sates has ceased to be a
serious danger to the public health, whichever is sooner. I may further
amend or extend the March 20, 2020 Order as needed to protect the
public health.
This Order is not a rule subject to notice and comment under the
Administrative Procedure Act (APA). In the event this order qualifies
as a rule subject to notice and comment, a delay in effective date are
not required because there is good cause to dispense with prior public
notice and the opportunity to comment on this order and a delay in
effective date.\23\ Given the public health emergency caused by COVID-
19, it would be impracticable and contrary to the public health--and,
by extension, the public interest--to delay the issuing and effective
date of this order. In addition, because this order concerns ongoing
discussions with Canada and Mexico on how to best control COVID-19
transmission over our shared borders, it directly ``involve[s] . . . a
. . . foreign affairs function of the United States.'' 5 U.S.C.
553(a)(1). Notice and comment and a delay in effective date would not
be required for that reason as well.
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\23\ See 5 U.S.C. 553(b)(B) and (d)(3).
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* * * * *
The March 20, 2020 Order shall remain in effect until 11:59 p.m.
EDT on May 20, 2020.
Authority
The authority for these orders is Sections 362 and 365 of the
Public Health Service Act (42 U.S.C. 265, 268) and 42 CFR 71.40.
Dated: April 19, 2020.
Robert K. McGowan,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2020-08605 Filed 4-20-20; 9:00 am]
BILLING CODE 4163-18-P