Termination of Arrival Restrictions Applicable to Flights Carrying Persons Who Have Recently Traveled From or Were Otherwise Present Within Uganda, 2517-2518 [2023-00793]
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Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations
d.1.b.1. Capable of being sterilized or
disinfected in-situ; or
d.1.b.2. Using disposable or single-use
filtration ‘‘parts’’ or ‘‘components’’.
N.B.: 2B352.d.1 does not control reverse
osmosis and hemodialysis equipment, as
specified by the manufacturer.
d.2. Cross (tangential) flow filtration
‘‘parts’’ or ‘‘components’’ (e.g., modules,
elements, cassettes, cartridges, units or
plates) with filtration area equal to or greater
than 0.2 square meters (0.2 m2) for each
‘‘part’’ or ‘‘component’’ and designed for use
in cross (tangential) flow filtration equipment
controlled by 2B352.d.1.
Technical Note: In this ECCN,
‘‘sterilized’’ denotes the elimination of all
viable microbes from the equipment through
the use of either physical (e.g., steam) or
chemical agents. ‘‘Disinfected’’ denotes a
process to reduce the number of
microorganisms, but not usually of bacterial
spores, through the use of chemical agents,
without necessarily killing or removing all
organisms.
e. Steam, gas or vapor sterilizable freezedrying equipment with a condenser capacity
of 10 kg of ice or greater in 24 hours (10 liters
of water or greater in 24 hours) and less than
1000 kg of ice in 24 hours (less than 1,000
liters of water in 24 hours).
f. Spray-drying equipment capable of
drying toxins or pathogenic microorganisms
having all of the following characteristics:
f.1. A water evaporation capacity of ≥0.4
kg/h and ≤400 kg/h;
f.2. The ability to generate a typical mean
product particle size of ≤10 micrometers with
existing fittings or by minimal modification
of the spray-dryer with atomization nozzles
enabling generation of the required particle
size; and
f.3. Capable of being sterilized or
disinfected in situ.
g. Protective and containment equipment,
as follows:
g.1. Protective full or half suits, or hoods
dependent upon a tethered external air
supply and operating under positive
pressure.
Technical Note to 2B352.g.1: 2B352.g.1
does not control suits designed to be worn
with self-contained breathing apparatus.
g.2. Biocontainment chambers, isolators, or
biological safety cabinets having all of the
following characteristics, for normal
operation:
g.2.a. Fully enclosed workspace where the
operator is separated from the work by a
physical barrier;
g.2.b. Able to operate at negative pressure;
g.2.c. Means to safely manipulate items in
the workspace; and
g.2.d. Supply and exhaust air to and from
the workspace is high-efficiency particulate
air (HEPA) filtered.
Note 1 to 2B352.g.2: 2B352.g.2 controls
class III biosafety cabinets, as specified in the
WHO Laboratory Biosafety Manual (3rd
edition, Geneva, 2004) or constructed in
accordance with national standards,
regulations or guidance.
Note 2 to 2B352.g.2: 2B352.g.2 controls any
isolator having all of the characteristics
described in 2B352.g.2.a through g.2.d,
regardless of its intended use and its
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designation, except for medical isolators
‘‘specially designed’’ for barrier nursing or
transportation of infected patients.
h. Aerosol inhalation equipment designed
for aerosol challenge testing with
microorganisms, viruses or toxins, as follows:
h.1. Whole-body exposure chambers
having a capacity of 1 cubic meter or greater;
h.2. Nose-only exposure apparatus
utilizing directed aerosol flow and having a
capacity for the exposure of 12 or more
rodents, or two or more animals other than
rodents, and closed animal restraint tubes
designed for use with such apparatus.
i. Spraying or fogging systems and ‘‘parts’’
and ‘‘components’’ therefor, as follows:
i.1. Complete spraying or fogging systems,
‘‘specially designed’’ or modified for fitting
to aircraft, ‘‘lighter than air vehicles,’’ or
‘‘UAVs,’’ capable of delivering, from a liquid
suspension, an initial droplet ‘‘VMD’’ of less
than 50 microns at a flow rate of greater than
2 liters per minute;
i.2. Spray booms or arrays of aerosol
generating units, ‘‘specially designed’’ or
modified for fitting to aircraft, ‘‘lighter than
air vehicles,’’ or ‘‘UAVs,’’ capable of
delivering, from a liquid suspension, an
initial droplet ‘‘VMD’’ of less than 50
microns at a flow rate of greater than 2 liters
per minute;
i.3. Aerosol generating units ‘‘specially
designed’’ for fitting to the systems as
specified in paragraphs i.1 and i.2 of this
ECCN.
Technical Notes to 2B352.i:
1. Aerosol generating units are devices
‘‘specially designed’’ or modified for fitting to
aircraft and include nozzles, rotary drum
atomizers and similar devices.
2. This ECCN does not control spraying or
fogging systems, ‘‘parts’’ and ‘‘components,’’
as specified in 2B352.i, that are
demonstrated not to be capable of delivering
biological agents in the form of infectious
aerosols.
3. Droplet size for spray equipment or
nozzles ‘‘specially designed’’ for use on
aircraft or ‘‘UAVs’’ should be measured using
either of the following methods (pending the
adoption of internationally accepted
standards):
a. Doppler laser method,
b. Forward laser diffraction method.
j. Nucleic acid assemblers and synthesizers
that are both:
j.1 Partly or entirely automated; and
j.2. Designed to generate continuous
nucleic acids greater than 1.5 kilobases in
length with error rates less than 5% in a
single run.
*
*
*
*
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Thea D. Rozman Kendler,
Assistant Secretary, for Export
Administration.
[FR Doc. 2023–00397 Filed 1–13–23; 8:45 am]
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2517
DEPARTMENT OF HOMELAND
SECURITY
Customs and Border Protection
19 CFR Chapter I
Termination of Arrival Restrictions
Applicable to Flights Carrying Persons
Who Have Recently Traveled From or
Were Otherwise Present Within
Uganda
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Announcement of termination
of arrival restrictions.
AGENCY:
This document announces the
decision of the Secretary of Homeland
Security to terminate arrival restrictions
applicable to flights to the United States
carrying persons who have recently
traveled from, or were otherwise present
within, Uganda due to an outbreak of
Ebola disease in Uganda. These
restrictions directed such flights to only
land at one of the United States airports
where the United States Government
had focused public health resources to
implement enhanced public health
measures.
DATES: The arrival restrictions
applicable to flights to the United States
carrying persons who have recently
traveled from, or were otherwise present
within, Uganda are terminated as of
11:59 p.m. Eastern Standard Time on
January 11, 2023.
FOR FURTHER INFORMATION CONTACT:
Stephanie Watson, Office of Field
Operations, U.S. Customs and Border
Protection at 202–255–7018.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
On October 12, 2022, the Secretary of
Homeland Security announced arrival
restrictions applicable to flights carrying
persons who have recently traveled
from, or were otherwise present within,
Uganda, consistent with 6 U.S.C. 112(a),
19 U.S.C. 1433(c), and 19 CFR 122.32,
in a Federal Register document titled
‘‘Arrival Restrictions Applicable to
Flights Carrying Persons Who Have
Recently Traveled From or Were
Otherwise Present Within Uganda’’ (87
FR 61488). For purposes of the October
2022 arrival restrictions, a person
recently traveled from Uganda if that
person departed from, or was otherwise
present within, Uganda within 21 days
of the date of the person’s entry or
attempted entry into the United States.
For the reasons set forth below, the
Secretary has decided to terminate the
arrival restrictions applicable to flights
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2518
Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations
carrying persons who have recently
traveled from, or were otherwise present
within, Uganda. These restrictions
funnel relevant arriving air passengers
to one of five designated airports of
entry where the U.S. is implementing
enhanced public health measures. Since
November 27, 2022, there have been no
new confirmed Ebola disease cases
reported in Uganda and two 21-day
incubation periods have passed. With
no new hospitalized patients with Ebola
disease, and no contacts of confirmed
Ebola disease cases still requiring
monitoring, the potential risk for
Ebolavirus exposure in Uganda has
greatly diminished. Therefore, flight
arrival restrictions are no longer
required for flights to the United States
carrying persons who have recently
traveled from, or were otherwise present
within, Uganda.
Notice of Termination of Arrival
Restrictions Applicable to All Flights
Carrying Persons Who Have Recently
Traveled From or Were Otherwise
Present Within Uganda
Pursuant to 6 U.S.C. 112(a), 19 U.S.C.
1433(c), and 19 CFR 122.32, and
effective as of 11:59 p.m. Eastern
Standard Time on January 11, 2023, for
all affected flights arriving at a United
States airport, I hereby terminate the
arrival restrictions applicable to flights
to the United States carrying persons
who have recently traveled from, or
were otherwise present within, Uganda
announced in the Arrival Restrictions
document published at 87 FR 61488
(October 12, 2022).
Alejandro Mayorkas,
Secretary, U.S. Department of Homeland
Security.
[FR Doc. 2023–00793 Filed 1–11–23; 4:45 pm]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
khammond on DSKJM1Z7X2PROD with RULES
[Docket No. FDA–2022–N–3335]
Medical Devices; Clinical Chemistry
and Clinical Toxicology Devices;
Classification of the Prognostic Test
for Assessment of Liver Related
Disease Progression
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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15:51 Jan 13, 2023
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classifying the prognostic test for
assessment of liver related disease
progression into class II (special
controls). The special controls that
apply to the device type are identified
in this order and will be part of the
codified language for the prognostic test
for assessment of liver related disease
progression’s classification. We are
taking this action because we have
determined that classifying the device
into class II (special controls) will
provide a reasonable assurance of safety
and effectiveness of the device. We
believe this action will also enhance
patients’ access to beneficial innovative
devices.
DATES: This order is effective January
17, 2023. The classification was
applicable on August 20, 2021.
FOR FURTHER INFORMATION CONTACT:
Irene Tebbs, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3526, Silver Spring,
MD 20993–0002, 340–402–0283,
Irene.Tebbs@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
prognostic test for assessment of liver
related disease progression as class II
(special controls), which we have
determined will provide a reasonable
assurance of safety and effectiveness. In
addition, we believe this action will
enhance patients’ access to beneficial
innovation, in part by placing the device
into a lower device class than the
automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (see 21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
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substantially equivalent to a predicate
device by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115) established
the first procedure for De Novo
classification. Section 607 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
modified the De Novo application
process by adding a second procedure.
A device sponsor may utilize either
procedure for De Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA is required to
classify the device by written order
within 120 days. The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act.
Although the device was automatically
placed within class III, the De Novo
classification is considered to be the
initial classification of the device.
When FDA classifies a device into
class I or II via the De Novo process, the
device can serve as a predicate for
future devices of that type, including for
510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device
sponsors do not have to submit a De
Novo request or premarket approval
application to market a substantially
equivalent device (see section 513(i) of
the FD&C Act, defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On November 4, 2020, FDA received
Siemens Healthcare Diagnostics Inc.’s
request for De Novo classification of the
ADVIA Centaur Enhanced Liver
Fibrosis. FDA reviewed the request in
order to classify the device under the
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Agencies
[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Rules and Regulations]
[Pages 2517-2518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00793]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Customs and Border Protection
19 CFR Chapter I
Termination of Arrival Restrictions Applicable to Flights
Carrying Persons Who Have Recently Traveled From or Were Otherwise
Present Within Uganda
AGENCY: U.S. Customs and Border Protection, Department of Homeland
Security.
ACTION: Announcement of termination of arrival restrictions.
-----------------------------------------------------------------------
SUMMARY: This document announces the decision of the Secretary of
Homeland Security to terminate arrival restrictions applicable to
flights to the United States carrying persons who have recently
traveled from, or were otherwise present within, Uganda due to an
outbreak of Ebola disease in Uganda. These restrictions directed such
flights to only land at one of the United States airports where the
United States Government had focused public health resources to
implement enhanced public health measures.
DATES: The arrival restrictions applicable to flights to the United
States carrying persons who have recently traveled from, or were
otherwise present within, Uganda are terminated as of 11:59 p.m.
Eastern Standard Time on January 11, 2023.
FOR FURTHER INFORMATION CONTACT: Stephanie Watson, Office of Field
Operations, U.S. Customs and Border Protection at 202-255-7018.
SUPPLEMENTARY INFORMATION:
Background
On October 12, 2022, the Secretary of Homeland Security announced
arrival restrictions applicable to flights carrying persons who have
recently traveled from, or were otherwise present within, Uganda,
consistent with 6 U.S.C. 112(a), 19 U.S.C. 1433(c), and 19 CFR 122.32,
in a Federal Register document titled ``Arrival Restrictions Applicable
to Flights Carrying Persons Who Have Recently Traveled From or Were
Otherwise Present Within Uganda'' (87 FR 61488). For purposes of the
October 2022 arrival restrictions, a person recently traveled from
Uganda if that person departed from, or was otherwise present within,
Uganda within 21 days of the date of the person's entry or attempted
entry into the United States.
For the reasons set forth below, the Secretary has decided to
terminate the arrival restrictions applicable to flights
[[Page 2518]]
carrying persons who have recently traveled from, or were otherwise
present within, Uganda. These restrictions funnel relevant arriving air
passengers to one of five designated airports of entry where the U.S.
is implementing enhanced public health measures. Since November 27,
2022, there have been no new confirmed Ebola disease cases reported in
Uganda and two 21-day incubation periods have passed. With no new
hospitalized patients with Ebola disease, and no contacts of confirmed
Ebola disease cases still requiring monitoring, the potential risk for
Ebolavirus exposure in Uganda has greatly diminished. Therefore, flight
arrival restrictions are no longer required for flights to the United
States carrying persons who have recently traveled from, or were
otherwise present within, Uganda.
Notice of Termination of Arrival Restrictions Applicable to All Flights
Carrying Persons Who Have Recently Traveled From or Were Otherwise
Present Within Uganda
Pursuant to 6 U.S.C. 112(a), 19 U.S.C. 1433(c), and 19 CFR 122.32,
and effective as of 11:59 p.m. Eastern Standard Time on January 11,
2023, for all affected flights arriving at a United States airport, I
hereby terminate the arrival restrictions applicable to flights to the
United States carrying persons who have recently traveled from, or were
otherwise present within, Uganda announced in the Arrival Restrictions
document published at 87 FR 61488 (October 12, 2022).
Alejandro Mayorkas,
Secretary, U.S. Department of Homeland Security.
[FR Doc. 2023-00793 Filed 1-11-23; 4:45 pm]
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