Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 4020 [2023-01208]
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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]
BILLING CODE P
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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]
[Page 4020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01208]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1133]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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 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 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Remifentanil........................... 9739 II
------------------------------------------------------------------------
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 non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01208 Filed 1-20-23; 8:45 am]
BILLING CODE P
