19 CFR Chapter I, 44185-44186 [2020-15955]
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Federal Register / Vol. 85, No. 141 / Wednesday, July 22, 2020 / Rules and Regulations
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
19 CFR Chapter I
Notification of Temporary Travel
Restrictions Applicable To Land Ports
of Entry and Ferries Service Between
the United States and Canada
Office of the Secretary, U.S.
Department of Homeland Security; U.S.
Customs and Border Protection, U.S.
Department of Homeland Security.
ACTION: Notification of continuation of
temporary travel restrictions.
AGENCY:
This document announces the
decision of the Secretary of Homeland
Security (Secretary) to continue to
temporarily limit the travel of
individuals from Canada into the United
States at land ports of entry along the
United States-Canada border. Such
travel will be limited to ‘‘essential
travel,’’ as further defined in this
document.
DATES: These restrictions go into effect
at 12 a.m. Eastern Daylight Time (EDT)
on July 22, 2020 and will remain in
effect until 11:59 p.m. EDT on August
20, 2020.
FOR FURTHER INFORMATION CONTACT:
Alyce Modesto, Office of Field
Operations, U.S. Customs and Border
Protection (CBP) at 202–344–3788.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Background
On March 24, 2020, DHS published
notice of the Secretary’s decision to
temporarily limit the travel of
individuals from Canada into the United
States at land ports of entry along the
United States-Canada border to
‘‘essential travel,’’ as further defined in
that document.1 The document
described the developing circumstances
regarding the COVID–19 pandemic and
stated that, given the outbreak and
continued transmission and spread of
the virus associated with COVID–19
within the United States and globally,
the Secretary had determined that the
risk of continued transmission and
spread of the virus associated with
COVID–19 between the United States
and Canada posed a ‘‘specific threat to
human life or national interests.’’ The
Secretary later published a series of
1 85 FR 16548 (Mar. 24, 2020). That same day,
DHS also published notice of the Secretary’s
decision to temporarily limit the travel of
individuals from Mexico into the United States at
land ports of entry along the United States-Mexico
border to ‘‘essential travel,’’ as further defined in
that document. 85 FR 16547 (Mar. 24, 2020).
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notifications continuing such
limitations on travel until 11:59 p.m.
EDT on July 21, 2020.2
The Secretary has continued to
monitor and respond to the COVID–19
pandemic. As of July 16, there are over
13.3 million confirmed cases globally,
with over 580,000 confirmed deaths.3
There are over 3.4 million confirmed
and probable cases within the United
States,4 over 108,000 confirmed cases in
Canada,5 and over 311,000 confirmed
cases in Mexico.6
Notice of Action
Given the outbreak and continued
transmission and spread of COVID–19
within the United States and globally,
the Secretary has determined that the
risk of continued transmission and
spread of the virus associated with
COVID–19 between the United States
and Canada poses an ongoing ‘‘specific
threat to human life or national
interests.’’
U.S. and Canadian officials have
mutually determined that non-essential
travel between the United States and
Canada poses additional risk of
transmission and spread of the virus
associated with COVID–19 and places
the populace of both nations at
increased risk of contracting the virus
associated with COVID–19. Moreover,
given the sustained human-to-human
transmission of the virus, returning to
previous levels of travel between the
two nations places the personnel
staffing land ports of entry between the
United States and Canada, as well as the
individuals traveling through these
ports of entry, at increased risk of
exposure to the virus associated with
COVID–19. Accordingly, and consistent
with the authority granted in 19 U.S.C.
1318(b)(1)(C) and (b)(2),7 I have
2 See 85 FR 37744 (June 24, 2020); 85 FR 31050
(May 22, 2020); 85 FR 22352 (Apr. 22, 2020). DHS
also published parallel notifications of the
Secretary’s decisions to continue temporarily
limiting the travel of individuals from Mexico into
the United States at land ports of entry along the
United States-Mexico border to ‘‘essential travel.’’
See 85 FR 37745 (June 24, 2020); 85 FR 31057 (May
22, 2020); 85 FR 22353 (Apr. 22, 2020).
3 WHO, Coronavirus disease 2019 (COVID–19)
Situation Report—178 (July 16, 2020), available at
https://www.who.int/docs/default-source/
coronaviruse/situation-reports/20200716-covid-19sitrep-178.pdf?sfvrsn=28ee165b_2.
4 CDC, Cases of COVID–19 in the U.S. (last
updated July 16, 2020), available at https://
www.cdc.gov/coronavirus/2019-ncov/casesupdates/cases-in-us.html.
5 WHO, Coronavirus disease 2019 (COVID–19)
Situation Report—178 (July 16, 2020).
6 Id.
7 19 U.S.C. 1318(b)(1)(C) provides that
‘‘[n]otwithstanding any other provision of law, the
Secretary of the Treasury, when necessary to
respond to a national emergency declared under the
National Emergencies Act (50 U.S.C. 1601 et seq.)
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44185
determined that land ports of entry
along the U.S.-Canada border will
continue to suspend normal operations
and will only allow processing for entry
into the United States of those travelers
engaged in ‘‘essential travel,’’ as defined
below. Given the definition of ‘‘essential
travel’’ below, this temporary alteration
in land ports of entry operations should
not interrupt legitimate trade between
the two nations or disrupt critical
supply chains that ensure food, fuel,
medicine, and other critical materials
reach individuals on both sides of the
border.
For purposes of the temporary
alteration in certain designated ports of
entry operations authorized under 19
U.S.C. 1318(b)(1)(C) and (b)(2), travel
through the land ports of entry and ferry
terminals along the United StatesCanada border shall be limited to
‘‘essential travel,’’ which includes, but
is not limited to—
• U.S. citizens and lawful permanent
residents returning to the United States;
• Individuals traveling for medical
purposes (e.g., to receive medical
treatment in the United States);
• Individuals traveling to attend
educational institutions;
• Individuals traveling to work in the
United States (e.g., individuals working
in the farming or agriculture industry
who must travel between the United
States and Canada in furtherance of
such work);
• Individuals traveling for emergency
response and public health purposes
(e.g., government officials or emergency
responders entering the United States to
support federal, state, local, tribal, or
territorial government efforts to respond
to COVID–19 or other emergencies);
• Individuals engaged in lawful crossborder trade (e.g., truck drivers
or to a specific threat to human life or national
interests,’’ is authorized to ‘‘[t]ake any . . . action
that may be necessary to respond directly to the
national emergency or specific threat.’’ On March
1, 2003, certain functions of the Secretary of the
Treasury were transferred to the Secretary of
Homeland Security. See 6 U.S.C. 202(2), 203(1).
Under 6 U.S.C. 212(a)(1), authorities ‘‘related to
Customs revenue functions’’ were reserved to the
Secretary of the Treasury. To the extent that any
authority under section 1318(b)(1) was reserved to
the Secretary of the Treasury, it has been delegated
to the Secretary of Homeland Security. See Treas.
Dep’t Order No. 100–16 (May 15, 2003), 68 FR
28322 (May 23, 2003). Additionally, 19 U.S.C.
1318(b)(2) provides that ‘‘[n]otwithstanding any
other provision of law, the Commissioner of U.S.
Customs and Border Protection, when necessary to
respond to a specific threat to human life or
national interests, is authorized to close temporarily
any Customs office or port of entry or take any other
lesser action that may be necessary to respond to
the specific threat.’’ Congress has vested in the
Secretary of Homeland Security the ‘‘functions of
all officers, employees, and organizational units of
the Department,’’ including the Commissioner of
CBP. 6 U.S.C. 112(a)(3).
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Federal Register / Vol. 85, No. 141 / Wednesday, July 22, 2020 / Rules and Regulations
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supporting the movement of cargo
between the United States and Canada);
• Individuals engaged in official
government travel or diplomatic travel;
• Members of the U.S. Armed Forces,
and the spouses and children of
members of the U.S. Armed Forces,
returning to the United States; and
• Individuals engaged in militaryrelated travel or operations.
The following travel does not fall
within the definition of ‘‘essential
travel’’ for purposes of this
Notification—
• Individuals traveling for tourism
purposes (e.g., sightseeing, recreation,
gambling, or attending cultural events).
At this time, this Notification does not
apply to air, freight rail, or sea travel
between the United States and Canada,
but does apply to passenger rail,
passenger ferry travel, and pleasure boat
travel between the United States and
Canada. These restrictions are
temporary in nature and shall remain in
effect until 11:59 p.m. EDT on August
20, 2020. This Notification may be
amended or rescinded prior to that time,
based on circumstances associated with
the specific threat.
The Commissioner of U.S. Customs
and Border Protection (CBP) is hereby
directed to prepare and distribute
appropriate guidance to CBP personnel
on the continued implementation of the
temporary measures set forth in this
Notification. The CBP Commissioner
may determine that other forms of
travel, such as travel in furtherance of
economic stability or social order,
constitute ‘‘essential travel’’ under this
Notification. Further, the CBP
Commissioner may, on an
individualized basis and for
humanitarian reasons or for other
purposes in the national interest, permit
the processing of travelers to the United
States not engaged in ‘‘essential travel.’’
The Acting Secretary of Homeland
Security, Chad F. Wolf, having reviewed
and approved this document, is
delegating the authority to electronically
sign this document to Chad R. Mizelle,
who is the Senior Official Performing
the Duties of the General Counsel for
DHS, for purposes of publication in the
Federal Register.
Chad R. Mizelle,
Senior Official Performing the Duties of the
General Counsel, U.S. Department of
Homeland Security.
[FR Doc. 2020–15955 Filed 7–21–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 884, 888, and 890
[Docket No. FDA–2019–N–2686]
Medical Devices; Exemptions From
Premarket Notification: Class II
Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA or the Agency) is
publishing an order setting forth the
Agency’s final determination to exempt
a list of class II devices from premarket
notification (510(k)) requirements,
subject to certain limitations. This
exemption from 510(k), subject to
certain limitations, is immediately in
effect for the list of class II devices. The
exemption will decrease regulatory
burdens on the medical device industry
and will eliminate private costs and
expenditures required to comply with
certain Federal regulations. FDA is also
amending the codified language for the
list of class II devices to reflect this final
determination. FDA is publishing this
order in accordance with the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
SUMMARY:
DATES:
This order is effective July 22,
2020.
FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1528, Silver Spring,
MD 20993, 301–796–6424,
Jismi.johnson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and its implementing
regulations in part 807, subpart E (21
CFR part 807, subpart E), persons who
propose to begin the introduction or
delivery for introduction into interstate
commerce for commercial distribution
of a device intended for human use are
required to submit a 510(k) to FDA. The
device may not be marketed until FDA
finds it ‘‘substantially equivalent’’
within the meaning of section 513(i) of
the FD&C Act (21 U.S.C. 360c(i)) to a
legally marketed device that does not
require premarket approval.
On December 13, 2016, the 21st
Century Cures Act (Cures Act) (Pub. L.
114–255) was signed into law. Section
3054 of the Cures Act amended section
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510(m) of the FD&C Act. As amended,
section 510(m)(2) of the FD&C Act
provides that, 1 calendar day after the
date of publication of the final list under
section 510(m)(1)(B) of the FD&C Act,1
FDA may exempt a class II device from
the requirement to submit a report
under section 510(k) of the FD&C Act,
upon its own initiative or a petition of
an interested person, if FDA determines
that a 510(k) is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. This section
requires FDA to publish in the Federal
Register a notice of intent to exempt a
device, or of the petition, and provide
a 60-calendar-day comment period.
Within 120 days of publication of such
notice, FDA shall publish an order in
the Federal Register that sets forth its
final determination regarding the
exemption of the device that was the
subject of the notice.
In the Federal Register of October 25,
2019 (84 FR 57445), in accordance with
the amendments to section 510(m)(2) of
the FD&C Act, on its own initiative,
FDA issued a notice of intent to exempt
the identified class II devices from
premarket notification requirements
under section 510(k) of the FD&C Act,
subject to certain limitations. Having
received no comments to the docket
following a 60-day comment period,
FDA is issuing this order to set forth our
final determination to exempt the class
II devices that were the subject of the
notice. Through this action, FDA is now
amending the codified language for each
identified classification regulation to
reflect our final determinations for these
class II exemptions.2
II. Criteria for Exemption
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. These
factors are discussed in the January 21,
1998, Federal Register notice (63 FR
3142) and subsequently in the guidance
we issued on February 19, 1998, entitled
‘‘Procedures for Class II Device
Exemptions From Premarket
Notification, Guidance for Industry and
1 FDA published the final list under section
510(m)(1)(B) of the FD&C Act in the Federal
Register of July 11, 2017 (82 FR 31976).
2 FDA notes that the ‘‘ACTION’’ caption for this
final order is styled as ‘‘Final amendment; final
order,’’ rather than ‘‘Final order.’’ Beginning in
December 2019, this editorial change was made to
indicate that the document ‘‘amends’’ the Code of
Federal Regulations. The change was made in
accordance with the Office of Federal Register’s
(OFR) interpretations of the Federal Register Act (44
U.S.C. chapter 15), its implementing regulations (1
CFR 5.9 and parts 21 and 22), and the Document
Drafting Handbook.
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[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Rules and Regulations]
[Pages 44185-44186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15955]
[[Page 44185]]
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DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
19 CFR Chapter I
Notification of Temporary Travel Restrictions Applicable To Land
Ports of Entry and Ferries Service Between the United States and Canada
AGENCY: Office of the Secretary, U.S. Department of Homeland Security;
U.S. Customs and Border Protection, U.S. Department of Homeland
Security.
ACTION: Notification of continuation of temporary travel restrictions.
-----------------------------------------------------------------------
SUMMARY: This document announces the decision of the Secretary of
Homeland Security (Secretary) to continue to temporarily limit the
travel of individuals from Canada into the United States at land ports
of entry along the United States-Canada border. Such travel will be
limited to ``essential travel,'' as further defined in this document.
DATES: These restrictions go into effect at 12 a.m. Eastern Daylight
Time (EDT) on July 22, 2020 and will remain in effect until 11:59 p.m.
EDT on August 20, 2020.
FOR FURTHER INFORMATION CONTACT: Alyce Modesto, Office of Field
Operations, U.S. Customs and Border Protection (CBP) at 202-344-3788.
SUPPLEMENTARY INFORMATION:
Background
On March 24, 2020, DHS published notice of the Secretary's decision
to temporarily limit the travel of individuals from Canada into the
United States at land ports of entry along the United States-Canada
border to ``essential travel,'' as further defined in that document.\1\
The document described the developing circumstances regarding the
COVID-19 pandemic and stated that, given the outbreak and continued
transmission and spread of the virus associated with COVID-19 within
the United States and globally, the Secretary had determined that the
risk of continued transmission and spread of the virus associated with
COVID-19 between the United States and Canada posed a ``specific threat
to human life or national interests.'' The Secretary later published a
series of notifications continuing such limitations on travel until
11:59 p.m. EDT on July 21, 2020.\2\
---------------------------------------------------------------------------
\1\ 85 FR 16548 (Mar. 24, 2020). That same day, DHS also
published notice of the Secretary's decision to temporarily limit
the travel of individuals from Mexico into the United States at land
ports of entry along the United States-Mexico border to ``essential
travel,'' as further defined in that document. 85 FR 16547 (Mar. 24,
2020).
\2\ See 85 FR 37744 (June 24, 2020); 85 FR 31050 (May 22, 2020);
85 FR 22352 (Apr. 22, 2020). DHS also published parallel
notifications of the Secretary's decisions to continue temporarily
limiting the travel of individuals from Mexico into the United
States at land ports of entry along the United States-Mexico border
to ``essential travel.'' See 85 FR 37745 (June 24, 2020); 85 FR
31057 (May 22, 2020); 85 FR 22353 (Apr. 22, 2020).
---------------------------------------------------------------------------
The Secretary has continued to monitor and respond to the COVID-19
pandemic. As of July 16, there are over 13.3 million confirmed cases
globally, with over 580,000 confirmed deaths.\3\ There are over 3.4
million confirmed and probable cases within the United States,\4\ over
108,000 confirmed cases in Canada,\5\ and over 311,000 confirmed cases
in Mexico.\6\
---------------------------------------------------------------------------
\3\ WHO, Coronavirus disease 2019 (COVID-19) Situation Report--
178 (July 16, 2020), available at https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200716-covid-19-sitrep-178.pdf?sfvrsn=28ee165b_2.
\4\ CDC, Cases of COVID-19 in the U.S. (last updated July 16,
2020), available at https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
\5\ WHO, Coronavirus disease 2019 (COVID-19) Situation Report--
178 (July 16, 2020).
\6\ Id.
---------------------------------------------------------------------------
Notice of Action
Given the outbreak and continued transmission and spread of COVID-
19 within the United States and globally, the Secretary has determined
that the risk of continued transmission and spread of the virus
associated with COVID-19 between the United States and Canada poses an
ongoing ``specific threat to human life or national interests.''
U.S. and Canadian officials have mutually determined that non-
essential travel between the United States and Canada poses additional
risk of transmission and spread of the virus associated with COVID-19
and places the populace of both nations at increased risk of
contracting the virus associated with COVID-19. Moreover, given the
sustained human-to-human transmission of the virus, returning to
previous levels of travel between the two nations places the personnel
staffing land ports of entry between the United States and Canada, as
well as the individuals traveling through these ports of entry, at
increased risk of exposure to the virus associated with COVID-19.
Accordingly, and consistent with the authority granted in 19 U.S.C.
1318(b)(1)(C) and (b)(2),\7\ I have determined that land ports of entry
along the U.S.-Canada border will continue to suspend normal operations
and will only allow processing for entry into the United States of
those travelers engaged in ``essential travel,'' as defined below.
Given the definition of ``essential travel'' below, this temporary
alteration in land ports of entry operations should not interrupt
legitimate trade between the two nations or disrupt critical supply
chains that ensure food, fuel, medicine, and other critical materials
reach individuals on both sides of the border.
---------------------------------------------------------------------------
\7\ 19 U.S.C. 1318(b)(1)(C) provides that ``[n]otwithstanding
any other provision of law, the Secretary of the Treasury, when
necessary to respond to a national emergency declared under the
National Emergencies Act (50 U.S.C. 1601 et seq.) or to a specific
threat to human life or national interests,'' is authorized to
``[t]ake any . . . action that may be necessary to respond directly
to the national emergency or specific threat.'' On March 1, 2003,
certain functions of the Secretary of the Treasury were transferred
to the Secretary of Homeland Security. See 6 U.S.C. 202(2), 203(1).
Under 6 U.S.C. 212(a)(1), authorities ``related to Customs revenue
functions'' were reserved to the Secretary of the Treasury. To the
extent that any authority under section 1318(b)(1) was reserved to
the Secretary of the Treasury, it has been delegated to the
Secretary of Homeland Security. See Treas. Dep't Order No. 100-16
(May 15, 2003), 68 FR 28322 (May 23, 2003). Additionally, 19 U.S.C.
1318(b)(2) provides that ``[n]otwithstanding any other provision of
law, the Commissioner of U.S. Customs and Border Protection, when
necessary to respond to a specific threat to human life or national
interests, is authorized to close temporarily any Customs office or
port of entry or take any other lesser action that may be necessary
to respond to the specific threat.'' Congress has vested in the
Secretary of Homeland Security the ``functions of all officers,
employees, and organizational units of the Department,'' including
the Commissioner of CBP. 6 U.S.C. 112(a)(3).
---------------------------------------------------------------------------
For purposes of the temporary alteration in certain designated
ports of entry operations authorized under 19 U.S.C. 1318(b)(1)(C) and
(b)(2), travel through the land ports of entry and ferry terminals
along the United States-Canada border shall be limited to ``essential
travel,'' which includes, but is not limited to--
U.S. citizens and lawful permanent residents returning to
the United States;
Individuals traveling for medical purposes (e.g., to
receive medical treatment in the United States);
Individuals traveling to attend educational institutions;
Individuals traveling to work in the United States (e.g.,
individuals working in the farming or agriculture industry who must
travel between the United States and Canada in furtherance of such
work);
Individuals traveling for emergency response and public
health purposes (e.g., government officials or emergency responders
entering the United States to support federal, state, local, tribal, or
territorial government efforts to respond to COVID-19 or other
emergencies);
Individuals engaged in lawful cross-border trade (e.g.,
truck drivers
[[Page 44186]]
supporting the movement of cargo between the United States and Canada);
Individuals engaged in official government travel or
diplomatic travel;
Members of the U.S. Armed Forces, and the spouses and
children of members of the U.S. Armed Forces, returning to the United
States; and
Individuals engaged in military-related travel or
operations.
The following travel does not fall within the definition of
``essential travel'' for purposes of this Notification--
Individuals traveling for tourism purposes (e.g.,
sightseeing, recreation, gambling, or attending cultural events).
At this time, this Notification does not apply to air, freight
rail, or sea travel between the United States and Canada, but does
apply to passenger rail, passenger ferry travel, and pleasure boat
travel between the United States and Canada. These restrictions are
temporary in nature and shall remain in effect until 11:59 p.m. EDT on
August 20, 2020. This Notification may be amended or rescinded prior to
that time, based on circumstances associated with the specific threat.
The Commissioner of U.S. Customs and Border Protection (CBP) is
hereby directed to prepare and distribute appropriate guidance to CBP
personnel on the continued implementation of the temporary measures set
forth in this Notification. The CBP Commissioner may determine that
other forms of travel, such as travel in furtherance of economic
stability or social order, constitute ``essential travel'' under this
Notification. Further, the CBP Commissioner may, on an individualized
basis and for humanitarian reasons or for other purposes in the
national interest, permit the processing of travelers to the United
States not engaged in ``essential travel.''
The Acting Secretary of Homeland Security, Chad F. Wolf, having
reviewed and approved this document, is delegating the authority to
electronically sign this document to Chad R. Mizelle, who is the Senior
Official Performing the Duties of the General Counsel for DHS, for
purposes of publication in the Federal Register.
Chad R. Mizelle,
Senior Official Performing the Duties of the General Counsel, U.S.
Department of Homeland Security.
[FR Doc. 2020-15955 Filed 7-21-20; 8:45 am]
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