Aquatic Nuisance Species Task Force Meeting, 23038-23039 [2024-07057]
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23038
Federal Register / Vol. 89, No. 65 / Wednesday, April 3, 2024 / Notices
considers the totality of the
circumstances and makes such
determinations on a case-by-case basis.
The country of origin of the item’s
components, extent of the processing
that occurs within a country, and
whether such processing renders a
product with a new name, character,
and use are primary considerations in
such cases. Additionally, CBP considers
factors such as the resources expended
on product design and development, the
extent and nature of post-assembly
inspection and testing procedures, and
worker skill required during the actual
manufacturing process when
determining whether a substantial
transformation has occurred. No one
factor is determinative.
In deciding whether a substantial
transformation occurs in the
manufacture of chemical products such
as pharmaceuticals, CBP has
consistently examined the complexity of
the processing and whether the final
article retains the essential identity and
character of the raw material. To that
end, CBP has held that the processing of
pharmaceutical products from bulk form
into measured doses does not result in
a substantial transformation of the
product, even when the API is
combined with other inactive
ingredients. See, e.g., Headquarters
Ruling (‘‘HQ’’) 561975, dated April 3,
2002; HQ 561544, dated May 1, 2000;
HQ 735146, dated November 15, 1993;
HQ H267177, dated November 5, 2016;
HQ H233356, dated December 26, 2012;
HQ H284694, dated August 22, 2017,
and New York Ruling (‘‘NY’’) C85112,
dated March 27, 1998.
For instance, in HQ 561975, CBP held
that the processing of imported bulk
Japanese-origin anesthetic drugs into
dosage form in the United States did not
constitute a substantial transformation.
Although the bulk form of the drug
underwent testing operations, filtering,
and packaging in the United States,
these processes did not change the
chemical or physical properties of the
drug. Furthermore, there was no change
in the product’s name, which was
referred to as sevoflurane in both its
bulk and processed form. Additionally,
because the imported bulk drug had a
predetermined medicinal use as an
anesthetic drug, the processing in the
United States did not result in a change
in the product’s use. The country of
origin of the finished product was
therefore Japan.
More recently, in HQ H284694, CBP
reviewed the country of origin of
quinine sulfate capsules. In that case,
the German-manufactured API quinine
sulfate was exported to India in bulk
form, where it was combined with
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several inactive ingredients, granulated,
sieved and placed into gelatin capsules.
No change in its name occurred because
the product was referred to as ‘‘quinine
sulfate’’ both before and after
processing. Additionally, no change in
character occurred because the product
maintained the same chemical and
physical properties in its processed
form. Finally, because the product had
a predetermined medical use as an
antimalarial drug, no change in use
occurred after processing. Therefore, the
county of origin of the final product
remained Germany.
Similar to the encapsulation here, in
NY C85112, CBP reviewed the country
of origin of leuprolide acetate, sold
under the trade name Lupron Depot 7.5
mg. In that case, U.S.-manufactured
leuprolide acetate powder was exported
to Japan where it was combined with
certain excipients and encapsulated into
sterile microspheres. The purpose of
microencapsulating the leuprolide
acetate was to modify its delivery rate
from daily into a form that would be
released in the human body over a
period of one to four months. CBP
determined that the fundamental
character of the leuprolide acetate was
unchanged by the encapsulation
processing and that the foreign
processing did not result in a substantial
transformation of the U.S.-manufactured
leuprolide acetate.
The facts here closely follow the cases
cited above, as does our decision. The
processing of bulk imported
pharmaceuticals into dosage form, even
with the addition of inactive
ingredients, will not result in a
substantial transformation. In this case,
the processing begins with the
Norwegian-origin bulk Omega-3-Acid
Ethyl Esters, and after the product is
processed and combined with inactive
ingredients in China, it results in
Omega-3-Acid Ethyl Esters capsules.
There is no change in name after
processing. Furthermore, no change in
character occurs in China, as the
Omega-3-Acid Ethyl Esters maintain the
same chemical and physical properties
both before and after processing.
Finally, because the Omega-3-Acid
Ethyl Esters have a predetermined
medical use to ‘‘reduce TG levels in
adult patients with severe (≥500 mg/dL)
hypertriglyceridemia,’’ no change in use
occurs after it is processed in China.
Under these circumstances, and
consistent with previous CBP rulings,
we find that the county of origin of the
final product is Norway, where the
active pharmaceutical ingredient was
produced.
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HOLDING
Based on the information outlined
above, we determine that the Omega-3Acid Ethyl Esters made in Norway, do
not undergo a substantial transformation
when encapsulated into individual
doses and combined with inactive
ingredients in China. Therefore, the
country of origin of the Omega-3-Acid
Ethyl Esters capsules for purposes of
U.S. Government procurement is
Norway.
Notice of this final determination will
be given in the Federal Register, as
required by 19 CFR 177.29. Any partyat-interest other than the party which
requested this final determination may
request, pursuant to 19 CFR 177.31, that
CBP reexamine the matter anew and
issue a new final determination.
Pursuant to 19 CFR 177.30, any partyat-interest may, within 30 days of
publication of the Federal Register
Notice referenced above, seek judicial
review of this final determination before
the U.S. Court of International Trade.
Sincerely,
Alice A. Kipel,
Executive Director,
Regulations and Rulings,
Office of Trade.
[FR Doc. 2024–07065 Filed 4–2–24; 8:45 am]
BILLING CODE 3314–88–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–HQ–FAC–2024–N014;
FXFR13360900000–FF09F14000–245]
Aquatic Nuisance Species Task Force
Meeting
Fish and Wildlife Service,
Interior.
ACTION: Notice of meeting.
AGENCY:
The U.S. Fish and Wildlife
Service gives notice of a public meeting
of the Aquatic Nuisance Species (ANS)
Task Force, in accordance with the
Federal Advisory Committee Act. The
ANS Task Force’s purpose is to develop
and implement a program for U.S.
waters to prevent introduction and
dispersal of aquatic invasive species; to
monitor, control, and study such
species; and to disseminate related
information.
SUMMARY:
The ANS Task Force will meet
Wednesday and Thursday on May 8–9,
2024, from 8 a.m. to 5 p.m. each day
(eastern time). On Wednesday, May 8,
2024, there will be a site visit from 1
p.m. to 5 p.m. The site visit will include
presentations on, and viewing of,
DATES:
E:\FR\FM\03APN1.SGM
03APN1
Federal Register / Vol. 89, No. 65 / Wednesday, April 3, 2024 / Notices
aquatic invasive species control
projects.
Registration: Registration is required.
The deadline for registration is May 3,
2024. Also see ‘‘Public Input,’’ below.
Accessibility: The deadline for
accessibility accommodation requests is
May 3, 2024. Please see ‘‘Accessibility
Information,’’ below.
ADDRESSES: The meeting will take place
at the Gideon Putnam Room, Saratoga
Spa State Park, 19 Roosevelt Drive,
Saratoga Springs, NY 12866. Virtual
participation will also be available via
teleconference and broadcast over the
internet. To register and receive the web
address and telephone number for
virtual participation, contact the
Executive Secretary (see FOR FURTHER
INFORMATION CONTACT) or visit the ANS
Task Force website at https://
www.fws.gov/program/aquaticnuisance-species-task-force.
FOR FURTHER INFORMATION CONTACT:
Susan Pasko, Executive Secretary, ANS
Task Force, by telephone at (571) 623–
0608, or by email at Susan_Pasko@
fws.gov. Individuals in the United States
who are deaf, deafblind, hard of hearing,
or have a speech disability may dial 711
(TTY, TDD, or TeleBraille) to access
telecommunications relay services.
Individuals outside the United States
should use the relay services offered
within their country to make
international calls to the point-ofcontact in the United States.
SUPPLEMENTARY INFORMATION:
Introduction
The Aquatic Nuisance Species (ANS)
Task Force was established by the
Nonindigenous Aquatic Nuisance
Prevention and Control Act of 1990, as
amended (16 U.S.C. 4721–4728), and is
composed of Federal and ex-officio
members. The ANS Task Force’s
purpose is to develop and implement a
program for U.S. waters to prevent
introduction and dispersal of aquatic
invasive species; to monitor, control,
and study such species; and to
disseminate related information.
lotter on DSK11XQN23PROD with NOTICES1
Meeting Information
This meeting is open to the public.
The meeting agenda will include reports
from ANS Task Force members, regional
panels, and subcommittees; discussion
on priority outputs to advance the goals
identified in the ANS Task Force
Strategic Plan for 2020–2025;
presentations highlighting regional
invasive species challenges and
innovative measures for ANS
management and control;
recommendations by the ANS Task
Force regional panels; and public
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Jkt 262001
comment. The site visit will include
presentations on, and viewing of,
aquatic invasive species control projects
within the area, including marine rapid
assessment surveys conducted at local
marinas and Hydrilla control and
containment efforts in the Connecticut
River. The final agenda and other
related meeting information will be
posted on the ANS Task Force website,
https://www.fws.gov/program/aquaticnuisance-species-task-force.
Public Input
If you wish to provide oral public
comment or provide a written comment
for the ANS Task Force to consider,
contact the ANS Task Force Executive
Secretary (see FOR FURTHER INFORMATION
CONTACT) no later than May 1, 2024.
Depending on the number of people
who want to comment and the time
available, the amount of time for
individual oral comments may be
limited. Interested parties should
contact the ANS Task Force Executive
Secretary, in writing (see FOR FURTHER
INFORMATION CONTACT), for placement on
the public speaker list for this meeting.
Requests to address the ANS Task Force
during the meeting will be
accommodated in the order the requests
are received. Registered speakers who
wish to expand upon their oral
statements, or those who had wished to
speak but could not be accommodated
on the agenda, may submit written
statements to the Executive Secretary up
to 30 days following the meeting.
Accessibility Information
Please make requests in advance for
sign language interpreter services,
assistive listening devices, or other
reasonable accommodations. Please
contact the ANS Task Force Executive
Secretary (see FOR FURTHER INFORMATION
CONTACT) no later than May 3, 2024, to
give the U.S. Fish and Wildlife Service
sufficient time to process your request.
All reasonable accommodation requests
are managed on a case-by-case basis.
Public Disclosure
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
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23039
Authority: 5 U.S.C. ch. 10.
David A. Miko,
Co-Chair, Aquatic Nuisance Species Task
Force.
[FR Doc. 2024–07057 Filed 4–2–24; 8:45 am]
BILLING CODE 4333–15–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–HQ–FAC–2024–N017; FF09F42300
FVWF97920900000 XXX]
Sport Fishing and Boating Partnership
Council; Public Meeting
Fish and Wildlife Service,
Interior.
ACTION: Notice of meeting.
AGENCY:
The U.S. Fish and Wildlife
Service gives notice of a public meeting
of the Sport Fishing and Boating
Partnership Council (Council), in
accordance with the Federal Advisory
Committee Act.
DATES: The Council will meet on
Tuesday, May 14, 2024, from 8:30 a.m.
to 4:45 p.m. and Wednesday, May 15,
2024, from 8:30 a.m. to 12:30 p.m.
eastern time.
Registration: Registration is required.
The deadline for registration is May 10,
2024.
Accessibility: The deadline for
accessibility accommodation requests is
May 7, 2024. Please see Accessibility
Information, below.
ADDRESSES: The meeting will take place
at the Department of the Interior, 1849
C Street NW, Washington, DC 20240.
Virtual participation will also be
available via teleconference and
broadcast over the internet. To register
and receive the web address and
telephone number for virtual
participation, contact the Designated
Federal Officer (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Tom
McCann, Designated Federal Officer, by
email at thomas_mccann@fws.gov, or by
telephone at 571–329–3206. Individuals
in the United States who are deaf,
deafblind, hard of hearing, or have a
speech disability may dial 711 (TTY,
TDD, or TeleBraille) to access
telecommunications relay services.
Individuals outside the United States
should use the relay services offered
within their country to make
international calls to the point-ofcontact in the United States.
SUPPLEMENTARY INFORMATION:
Established in 1993, the Sport Fishing
and Boating Partnership Council
(Council) advises the Secretary of the
SUMMARY:
E:\FR\FM\03APN1.SGM
03APN1
Agencies
[Federal Register Volume 89, Number 65 (Wednesday, April 3, 2024)]
[Notices]
[Pages 23038-23039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07057]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS-HQ-FAC-2024-N014; FXFR13360900000-FF09F14000-245]
Aquatic Nuisance Species Task Force Meeting
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The U.S. Fish and Wildlife Service gives notice of a public
meeting of the Aquatic Nuisance Species (ANS) Task Force, in accordance
with the Federal Advisory Committee Act. The ANS Task Force's purpose
is to develop and implement a program for U.S. waters to prevent
introduction and dispersal of aquatic invasive species; to monitor,
control, and study such species; and to disseminate related
information.
DATES: The ANS Task Force will meet Wednesday and Thursday on May 8-9,
2024, from 8 a.m. to 5 p.m. each day (eastern time). On Wednesday, May
8, 2024, there will be a site visit from 1 p.m. to 5 p.m. The site
visit will include presentations on, and viewing of,
[[Page 23039]]
aquatic invasive species control projects.
Registration: Registration is required. The deadline for
registration is May 3, 2024. Also see ``Public Input,'' below.
Accessibility: The deadline for accessibility accommodation
requests is May 3, 2024. Please see ``Accessibility Information,''
below.
ADDRESSES: The meeting will take place at the Gideon Putnam Room,
Saratoga Spa State Park, 19 Roosevelt Drive, Saratoga Springs, NY
12866. Virtual participation will also be available via teleconference
and broadcast over the internet. To register and receive the web
address and telephone number for virtual participation, contact the
Executive Secretary (see FOR FURTHER INFORMATION CONTACT) or visit the
ANS Task Force website at https://www.fws.gov/program/aquatic-nuisance-species-task-force.
FOR FURTHER INFORMATION CONTACT: Susan Pasko, Executive Secretary, ANS
Task Force, by telephone at (571) 623-0608, or by email at
[email protected]. Individuals in the United States who are deaf,
deafblind, hard of hearing, or have a speech disability may dial 711
(TTY, TDD, or TeleBraille) to access telecommunications relay services.
Individuals outside the United States should use the relay services
offered within their country to make international calls to the point-
of-contact in the United States.
SUPPLEMENTARY INFORMATION:
Introduction
The Aquatic Nuisance Species (ANS) Task Force was established by
the Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990,
as amended (16 U.S.C. 4721-4728), and is composed of Federal and ex-
officio members. The ANS Task Force's purpose is to develop and
implement a program for U.S. waters to prevent introduction and
dispersal of aquatic invasive species; to monitor, control, and study
such species; and to disseminate related information.
Meeting Information
This meeting is open to the public. The meeting agenda will include
reports from ANS Task Force members, regional panels, and
subcommittees; discussion on priority outputs to advance the goals
identified in the ANS Task Force Strategic Plan for 2020-2025;
presentations highlighting regional invasive species challenges and
innovative measures for ANS management and control; recommendations by
the ANS Task Force regional panels; and public comment. The site visit
will include presentations on, and viewing of, aquatic invasive species
control projects within the area, including marine rapid assessment
surveys conducted at local marinas and Hydrilla control and containment
efforts in the Connecticut River. The final agenda and other related
meeting information will be posted on the ANS Task Force website,
https://www.fws.gov/program/aquatic-nuisance-species-task-force.
Public Input
If you wish to provide oral public comment or provide a written
comment for the ANS Task Force to consider, contact the ANS Task Force
Executive Secretary (see FOR FURTHER INFORMATION CONTACT) no later than
May 1, 2024.
Depending on the number of people who want to comment and the time
available, the amount of time for individual oral comments may be
limited. Interested parties should contact the ANS Task Force Executive
Secretary, in writing (see FOR FURTHER INFORMATION CONTACT), for
placement on the public speaker list for this meeting. Requests to
address the ANS Task Force during the meeting will be accommodated in
the order the requests are received. Registered speakers who wish to
expand upon their oral statements, or those who had wished to speak but
could not be accommodated on the agenda, may submit written statements
to the Executive Secretary up to 30 days following the meeting.
Accessibility Information
Please make requests in advance for sign language interpreter
services, assistive listening devices, or other reasonable
accommodations. Please contact the ANS Task Force Executive Secretary
(see FOR FURTHER INFORMATION CONTACT) no later than May 3, 2024, to
give the U.S. Fish and Wildlife Service sufficient time to process your
request. All reasonable accommodation requests are managed on a case-
by-case basis.
Public Disclosure
Before including your address, phone number, email address, or
other personal identifying information in your comment, you should be
aware that your entire comment--including your personal identifying
information--may be made publicly available at any time. While you can
ask us in your comment to withhold your personal identifying
information from public review, we cannot guarantee that we will be
able to do so.
Authority: 5 U.S.C. ch. 10.
David A. Miko,
Co-Chair, Aquatic Nuisance Species Task Force.
[FR Doc. 2024-07057 Filed 4-2-24; 8:45 am]
BILLING CODE 4333-15-P