Importer of Controlled Substances Application: Catalent CTS, LLC, 60498-60499 [2023-18919]
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Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices
(6) A list of all known and currently
operating U.S. importers of the Subject
Merchandise and producers of the
Subject Merchandise in the Subject
Country that currently export or have
exported Subject Merchandise to the
United States or other countries after
2017.
(7) A list of 3–5 leading purchasers in
the U.S. market for the Domestic Like
Product and the Subject Merchandise
(including street address, World Wide
Web address, and the name, telephone
number, fax number, and Email address
of a responsible official at each firm).
(8) A list of known sources of
information on national or regional
prices for the Domestic Like Product or
the Subject Merchandise in the U.S. or
other markets.
(9) If you are a U.S. producer of the
Domestic Like Product, provide the
following information on your firm’s
operations on that product during
calendar year 2022, except as noted
(report quantity data in
megavolt-amperes (‘‘MVA’’), and value
data in U.S. dollars, f.o.b. plant). If you
are a union/worker group or trade/
business association, provide the
information, on an aggregate basis, for
the firms in which your workers are
employed/which are members of your
association.
(a) Production (quantity) and, if
known, an estimate of the percentage of
total U.S. production of the Domestic
Like Product accounted for by your
firm’s(s’) production;
(b) Capacity (quantity) of your firm to
produce the Domestic Like Product (that
is, the level of production that your
establishment(s) could reasonably have
expected to attain during the year,
assuming normal operating conditions
(using equipment and machinery in
place and ready to operate), normal
operating levels (hours per week/weeks
per year), time for downtime,
maintenance, repair, and cleanup, and a
typical or representative product mix);
(c) the quantity and value of U.S.
commercial shipments of the Domestic
Like Product produced in your U.S.
plant(s);
(d) the quantity and value of U.S.
internal consumption/company
transfers of the Domestic Like Product
produced in your U.S. plant(s); and
(e) the value of (i) net sales, (ii) cost
of goods sold (COGS), (iii) gross profit,
(iv) selling, general and administrative
(SG&A) expenses, and (v) operating
income of the Domestic Like Product
produced in your U.S. plant(s) (include
both U.S. and export commercial sales,
internal consumption, and company
transfers) for your most recently
VerDate Sep<11>2014
17:24 Aug 31, 2023
Jkt 259001
completed fiscal year (identify the date
on which your fiscal year ends).
(10) If you are a U.S. importer or a
trade/business association of U.S.
importers of the Subject Merchandise
from the Subject Country, provide the
following information on your firm’s(s’)
operations on that product during
calendar year 2022 (report quantity data
in MVA and value data in U.S. dollars).
If you are a trade/business association,
provide the information, on an aggregate
basis, for the firms which are members
of your association.
(a) The quantity and value (landed,
duty-paid but not including
antidumping duties) of U.S. imports
and, if known, an estimate of the
percentage of total U.S. imports of
Subject Merchandise from the Subject
Country accounted for by your firm’s(s’)
imports;
(b) the quantity and value (f.o.b. U.S.
port, including antidumping duties) of
U.S. commercial shipments of Subject
Merchandise imported from the Subject
Country; and
(c) the quantity and value (f.o.b. U.S.
port, including antidumping duties) of
U.S. internal consumption/company
transfers of Subject Merchandise
imported from the Subject Country.
(11) If you are a producer, an exporter,
or a trade/business association of
producers or exporters of the Subject
Merchandise in the Subject Country,
provide the following information on
your firm’s(s’) operations on that
product during calendar year 2022
(report quantity data in MVA and value
data in U.S. dollars, landed and dutypaid at the U.S. port but not including
antidumping duties). If you are a trade/
business association, provide the
information, on an aggregate basis, for
the firms which are members of your
association.
(a) Production (quantity) and, if
known, an estimate of the percentage of
total production of Subject Merchandise
in the Subject Country accounted for by
your firm’s(s’) production;
(b) Capacity (quantity) of your firm(s)
to produce the Subject Merchandise in
the Subject Country (that is, the level of
production that your establishment(s)
could reasonably have expected to
attain during the year, assuming normal
operating conditions (using equipment
and machinery in place and ready to
operate), normal operating levels (hours
per week/weeks per year), time for
downtime, maintenance, repair, and
cleanup, and a typical or representative
product mix); and
(c) the quantity and value of your
firm’s(s’) exports to the United States of
Subject Merchandise and, if known, an
estimate of the percentage of total
PO 00000
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Fmt 4703
Sfmt 4703
exports to the United States of Subject
Merchandise from the Subject Country
accounted for by your firm’s(s’) exports.
(12) Identify significant changes, if
any, in the supply and demand
conditions or business cycle for the
Domestic Like Product that have
occurred in the United States or in the
market for the Subject Merchandise in
the Subject Country after 2017, and
significant changes, if any, that are
likely to occur within a reasonably
foreseeable time. Supply conditions to
consider include technology;
production methods; development
efforts; ability to increase production
(including the shift of production
facilities used for other products and the
use, cost, or availability of major inputs
into production); and factors related to
the ability to shift supply among
different national markets (including
barriers to importation in foreign
markets or changes in market demand
abroad). Demand conditions to consider
include end uses and applications; the
existence and availability of substitute
products; and the level of competition
among the Domestic Like Product
produced in the United States, Subject
Merchandise produced in the Subject
Country, and such merchandise from
other countries.
(13) (OPTIONAL) A statement of
whether you agree with the above
definitions of the Domestic Like Product
and Domestic Industry; if you disagree
with either or both of these definitions,
please explain why and provide
alternative definitions.
Authority: This proceeding is being
conducted under authority of title VII of
the Tariff Act of 1930; this notice is
published pursuant to § 207.61 of the
Commission’s rules.
By order of the Commission.
Issued: August 25, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023–18731 Filed 8–31–23; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1254]
Importer of Controlled Substances
Application: Catalent CTS, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent CTS, LLC. has
applied to be registered as an importer
of basic class(es) of controlled
SUMMARY:
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60499
Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before October 2, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 2, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 13, 2023, Catalent
CTS, LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137–1418,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Gamma Hydroxybutyric
Acid.
Marihuana Extract ...........
Marihuana Extract ...........
Tetrahydrocannabinols ....
Drug
code
Schedule
2010
I
7350
7360
7370
I
I
I
The company plans to import the
listed controlled substances as dosage
unit products for clinical trial studies.
In reference to drug codes 7370
(Tetrahydrocannabinols), the company
plans to import a synthetic
VerDate Sep<11>2014
17:24 Aug 31, 2023
Jkt 259001
tetrahydrocannabinol. No other
activities for these drug codes are
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–18919 Filed 8–31–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on August 15, 2023, Fisher
Clinical Services, Inc., 7554 Schantz
Road, Allentown, Pennsylvania 18106–
9032, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Drug
code
Schedule
7437
7350
1724
9220
9668
9780
I
I
II
II
II
II
[Docket No. DEA–1253]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Fisher Clinical Services, Inc.,
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before October 2, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 2, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
SUMMARY:
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Fmt 4703
Sfmt 4703
Psilocybin ........................
Marihuana Extract ...........
Methylphenidate ..............
Levorphanol .....................
Noroxymorphone .............
Tapentadol ......................
The company plans to import the
listed controlled substances for clinical
trials only. No other activities for these
drug codes are authorized for this
registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–18922 Filed 8–31–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1251]
Bulk Manufacturer of Controlled
Substances Application: Curia
Wisconsin, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Curia Wisconsin, Inc has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
SUMMARY:
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Notices]
[Pages 60498-60499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18919]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1254]
Importer of Controlled Substances Application: Catalent CTS, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Catalent CTS, LLC. has applied to be registered as an importer
of basic class(es) of controlled
[[Page 60499]]
substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for
further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
October 2, 2023. Such persons may also file a written request for a
hearing on the application on or before October 2, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on July 13, 2023, Catalent CTS, LLC, 10245 Hickman Mills
Drive, Kansas City, Missouri 64137-1418, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 2010 I
Marihuana Extract....................... 7350 I
Marihuana Extract....................... 7360 I
Tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances as
dosage unit products for clinical trial studies. In reference to drug
codes 7370 (Tetrahydrocannabinols), the company plans to import a
synthetic tetrahydrocannabinol. No other activities for these drug
codes are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-18919 Filed 8-31-23; 8:45 am]
BILLING CODE P
