Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 4021 [2023-01202]
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4021
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
Controlled substance
Drug
code
Hydromorphone ......................
Hydrocodone ...........................
Methadone ..............................
Methadone intermediate .........
Morphine .................................
Oripavine .................................
Thebaine .................................
Opium tincture ........................
Oxymorphone .........................
Tapentadol ..............................
9150
9193
9250
9254
9300
9330
9333
9630
9652
9780
Schedule
II
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture the listed controlled
substances in bulk for sale to its
customers. No other activities for these
drug codes are authorized for this
registration.
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 30, 2022,
Maridose LLC, 74 Orion Street,
Brunswick, Maine 04011, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Drug
code
Controlled substance
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
I
7350
7360
7370
Schedule
I
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to supply to the Drug
Enforcement Administration-registered
researchers for their approval studies.
No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–01199 Filed 1–20–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Matthew Strait,
Deputy Assistant Administrator.
[Docket No. DEA–XXX]
[FR Doc. 2023–01203 Filed 1–20–23; 8:45 am]
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Bulk Manufacturer of Controlled
Substances Application: Maridose LLC
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
VerDate Sep<11>2014
16:44 Jan 20, 2023
Jkt 259001
In
accordance with 21 CFR 1301.34(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 an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1130]
Maridose 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
SUMMARY:
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.
Importer 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 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
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Methylphenidate ...........
Thebaine .......................
Poppy Straw Concentrate.
Tapentadol ....................
Drug
code
Schedule
1724
9333
9670
II
II
II
9780
II
The company plans to import
intermediates classified under
Tapentadol (9780) and Thebaine (9333)
for further manufacturing to the
controlled substances Tapentadol and
Buprenorpine, respectively, prior to
distribution to customers. The company
plans to import Poppy Straw
Concentrate (9670) to bulk manufacture
other controlled substances. No other
activity for this drug code is 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. 2023–01202 Filed 1–20–23; 8:45 am]
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E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Page 4021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01202]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1130]
Importer 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
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 1, 2022, Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645,
applied to be registered as an importer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
Thebaine............................... 9333 II
Poppy Straw Concentrate................ 9670 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to import intermediates classified under
Tapentadol (9780) and Thebaine (9333) for further manufacturing to the
controlled substances Tapentadol and Buprenorpine, respectively, prior
to distribution to customers. The company plans to import Poppy Straw
Concentrate (9670) to bulk manufacture other controlled substances. No
other activity for this drug code is 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. 2023-01202 Filed 1-20-23; 8:45 am]
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