Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 4019-4020 [2023-01205]
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<![CDATA[
4019
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
supplemented, alleged violations of
section 337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337, in the
importation into the United States, the
sale for importation, or the sale within
the United States after importation of
certain core orientation systems,
products containing core orientation
systems, components thereof, and
methods of using the same by reason of
infringement of claims 16–18, 22, and
23 of U.S. Patent No. 7,584,055. Id. The
complaint further alleged that an
industry in the United States exists or
is in the process of being established. Id.
The Commission’s notice of
investigation named as respondents:
Boart Longyear Group Ltd. of West
Valley City, UT; Boart Longyear Limited
of Australia; Boart Longyear Company
of West Valley City, UT; Boart Longyear
Manufacturing and Distribution Inc. of
West Valley City, UT; Longyear TM, Inc.
of West Valley City, UT; Globaltech
Corporation Pty Ltd. of Australia;
Globaltech Pty Ltd. of Australia; Granite
Construction Incorporated of
Watsonville, CA; and International
Directional Services LLC of Chandler,
AZ. The Office of Unfair Import
Investigations (‘‘OUII’’) is also named as
a party in this investigation. Id. at
19704–05.
On December 14, 2022, the
Commission determined not to review
an ID (Order No. 28) granting a joint
motion to terminate respondent Granite
Construction Incorporated from the
investigation based on withdrawal of
the complaint.
On November 30, 2022, Complainants
and the Remaining Respondents jointly
moved to terminate and stay the
investigation based on a consent order
stipulation. The joint motion included a
consent order stipulation, a proposed
consent order, and a settlement
agreement. OUII filed a response
supporting the joint motion.
On December 19, 2022, the ALJ issued
an ID (Order No. 31) granting the joint
motion to terminate the investigation
with respect to the Remaining
Respondents based on the entry of a
consent order. The ID found that the
consent order stipulation and proposed
consent order conform with
Commission Rule 210.21(c)(3) and (4)
(19 CFR 210.21(c)(3) and (4)). The ID
also found that termination of the
investigation with respect to the
Remaining Respondents would not be
contrary to the public interest. No
petitions for review were filed.
The Commission has determined not
to review the subject ID and to issue a
consent order against respondents Boart
Longyear Group Ltd.; Boart Longyear
Limited; Boart Longyear Company;
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16:44 Jan 20, 2023
Jkt 259001
Boart Longyear Manufacturing and
Distribution Inc.; Longyear TM, Inc.;
Globaltech Corporation Pty Ltd.;
Globaltech Pty Ltd.; and International
Directional Services LLC. The
investigation is terminated in its
entirety.
The Commission vote for this
determination took place on January 17,
2023.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337, and in part
210 of the Commission’s Rules of
Practice and Procedure, 19 CFR part
210.
By order of the Commission.
Issued: January 17, 2023.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2023–01105 Filed 1–20–23; 8:45 am]
EARLY TERMINATION GRANTED
11/04/2022
20221286 .....
G
Flatlake Privatshftung;
Global Tungsten &
Powders Corp.; Allan
C. Bir, Jr.; Mi-Tech
Tungsten Metals, LLC
B6 Manufacturing,
LLC.
01/05/2023
20222859 .....
G
I I
Semtech Corporation;
13548597 Canada,
Inc.; Sierra Wireless,
Inc.
Suzanne Morris,
Deputy Directory of Civil Enforcement
Operations, Antitrust Division, Department of
Justice.
[FR Doc. 2023–01198 Filed 1–20–23; 8:45 am]
BILLING CODE 4410–11–P
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–1134]
Antitrust Division
Granting of Requests for Early
Termination of the Waiting Period
Under the Premerger Notification
Rules
Section 7A of the Clayton Act, 15
U.S.C. 18a, as added by Title II of the
Hart-Scott-Rodino Antitrust
Improvements Act of 1976, requires
persons contemplating certain mergers
or acquisitions to give the Federal Trade
Commission and the Assistant Attorney
General advance notice and to wait
designated periods before
consummation of such plans. Section
7A(b)(2) of the Act permits the agencies,
in individual cases, to terminate this
waiting period prior to its expiration
and requires that notice of this action be
published in the Federal Register. The
following transactions were granted
early termination—on the date
indicated—of the waiting period
provided by law and the premerger
notification rules. The listing includes
the transaction number and the parties
to the transaction. The Federal Trade
Commission and the Assistant Attorney
General for the Antitrust Division of the
Department of Justice made the grants.
Neither agency intends to take any
action with respect to this proposed
acquisitions during the applicable
waiting period.
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Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen Pharmaceuticals 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.
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 March 24, 2023. Such
persons may also file a written request
for a hearing on the application on or
before March 24, 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
SUMMARY:
E:\FR\FM\23JAN1.SGM
23JAN1
4020
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on December 1, 2022,
Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Buildings 1–5 & 7–14,
Athens, Georgia 30601–1645, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
Controlled substance
Methylphenidate ...........
Hydromorphone ............
Hydrocodone ................
Oripavine ......................
Thebaine .......................
Tapentadol ....................
Drug
code
1724
9150
9193
9330
9333
9780
Schedule
II
II
II
II
II
II
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates or for sale to its
customers. No other activities for these
drug codes are authorized for this
registration.
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 6, 2022,
Mylan Pharmaceuticals, Inc., 2898
Manufacturers Road, Greensboro, North
Carolina 27406–4600, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–01205 Filed 1–20–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1133]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
Inc.
Remifentanil ..................
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Pharmaceuticals, 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 February 22, 2023. Such
persons may also file a written request
for a hearing on the application on or
before February 22, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:44 Jan 20, 2023
Jkt 259001
Drug
code
Controlled substance
I
9739
Schedule
III
The company plans to import the
above listed controlled substance in
finished dosage from for commercial
distribution to its customers. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–01208 Filed 1–20–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1129]
Bulk Manufacturer of Controlled
Substances Application: Siegfried
USA, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Siegfried USA, LLC 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.
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 March 24, 2023. Such
persons may also file a written request
for a hearing on the application on or
before March 24, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on November 8, 2022,
Siegfried USA, LLC, 33 Industrial Park
Road, Pennsville, New Jersey 08070–
3244, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUMMARY:
Controlled substance
Gamma Hydroxybutyric Acid ..
Noroxymorphone ....................
Hydromorphinol .......................
Amphetamine ..........................
Lisdexamfetamine ...................
Methylphenidate ......................
Amobarbital .............................
Pentobarbital ...........................
Secobarbital ............................
Codeine ...................................
Oxycodone ..............................
E:\FR\FM\23JAN1.SGM
23JAN1
Drug
code
2010
9145
9301
1100
1205
1724
2125
2270
2315
9050
9143
Schedule
I
I
I
II
II
II
II
II
II
II
II
]]>Agencies
[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 4019-4020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01205]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1134]
Bulk Manufacturer of Controlled Substances Application: Janssen
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Janssen Pharmaceuticals 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.
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
March 24, 2023. Such persons may also file a written request for a
hearing on the application on or before March 24, 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
[[Page 4020]]
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on December 1, 2022, Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645,
applied to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Oripavine.............................. 9330 II
Thebaine............................... 9333 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. No other activities for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01205 Filed 1-20-23; 8:45 am]
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