Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 14290 [2022-05314]
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14290
Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices
No other activities for these drug codes
are authorized for this registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug
code
Schedule
9220
II
Matthew J. Strait,
Deputy Assistant Administrator.
Levorphanol ....................
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals Inc.
[FR Doc. 2022–05314 Filed 3–11–22; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
DEPARTMENT OF JUSTICE
The company plans to bulk
manufacture the listed controlled
substances for the internal use or for
sale to its customers. No other activities
for these drug codes are authorized for
this registration.
[Docket No. DEA–982]
BILLING CODE P
AGENCY:
Drug Enforcement Administration
Janssen Pharmaceuticals Inc.,
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTAL 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 May 13, 2022. Such persons
may also file a written request for a
hearing on the application on or before
May 13, 2022.
ADDRESSES: DEA 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 December 10, 2021,
Janssen Pharmaceuticals Inc., 1440
Olympic Drive Athens, Georgia 30601–
1645, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUMMARY:
Controlled substance
jspears on DSK121TN23PROD with NOTICES1
Controlled substance
Methylphenidate .............
Hydromorphone ..............
Hydrocodone ..................
Oripavine ........................
Thebaine .........................
Tapentadol ......................
Drug
code
Schedule
1724
9150
9193
9330
9333
9780
II
II
II
II
II
II
[Docket No. DEA–978]
Bulk Manufacturer of Controlled
Substances: ANI Pharmaceuticals, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
VerDate Sep<11>2014
17:51 Mar 11, 2022
Jkt 256001
[FR Doc. 2022–05323 Filed 3–11–22; 8:45 am]
BILLING CODE P
AGENCY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ANI Pharmaceuticals, Inc.,
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTAL 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 May 13, 2022. Such persons
may also file a written request for a
hearing on the application on or before
May 13, 2022.
ADDRESSES: The DEA 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 January 6, 2022, ANI
Pharmaceuticals, Inc., 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUMMARY:
Controlled substance
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
Matthew J. Strait,
Deputy Assistant Administrator.
Psilocybin .......................
Psilocyn ..........................
PO 00000
Frm 00054
Fmt 4703
Drug
code
Schedule
7437
7438
I
I
Sfmt 4703
[Docket No. DEA–976]
Importer of Controlled Substances
Application: Meridian Medical
Technologies, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Meridian Medical
Technologies, LLC, 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.
SUMMARY:
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 April 13, 2022. Such
persons may also file a written request
for a hearing on the application on or
before April 13, 2022.
ADDRESSES: The DEA 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
DATES:
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Page 14290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05314]
[[Page 14290]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-982]
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 Supplemental 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
May 13, 2022. Such persons may also file a written request for a
hearing on the application on or before May 13, 2022.
ADDRESSES: DEA 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 December 10, 2021, Janssen Pharmaceuticals Inc., 1440
Olympic Drive 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 manufacture the above-listed controlled
substances in bulk for distribution to its customers. No other
activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-05314 Filed 3-11-22; 8:45 am]
BILLING CODE P
