Importer of Controlled Substances Application: Nexus Pharmaceuticals, Inc., 64251 [2022-23052]
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(API) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on September 1, 2022, Rocky Mountain
Biotech, LLC, 4740 Dillon Drive, Pueblo,
Colorado 81008–2112, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
Controlled substance
Drug code
Marihuana .........
7360
Schedule
I
Kristi O’Malley,
Assistant Administrator.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 19, 2022,
10300 128th Avenue, Pleasant Prairie,
Wisconsin 53158–7336, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1104]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Drug
code
Controlled substance
Importer of Controlled Substances
Application: Nexus Pharmaceuticals,
Inc.
Nexus 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.
SUMMARY:
19:12 Oct 21, 2022
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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2022–23050 Filed 10–21–22; 8:45 am]
VerDate Sep<11>2014
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 November 23, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 23, 2022.
DATES:
Jkt 259001
Remifentanil ..................
I
9739
Schedule
I
II
The company plans to import the
listed controlled substance for research
and analytical testing purposes.
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-
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
64251
approved finished dosage forms for
commercial sale.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–23052 Filed 10–21–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1105]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Manufacturing, Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Benuvia Manufacturing 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:
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 December 23, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2022.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 12, 2022,
Benuvia Manufacturing Inc., 3950 North
Mays Street, Round Rock, Texas 78665,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Page 64251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23052]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1104]
Importer of Controlled Substances Application: Nexus
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Nexus 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
November 23, 2022. Such persons may also file a written request for a
hearing on the application on or before November 23, 2022.
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 September 19, 2022, 10300 128th Avenue, Pleasant
Prairie, Wisconsin 53158-7336, 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 listed controlled substance for
research and analytical testing purposes. 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.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-23052 Filed 10-21-22; 8:45 am]
BILLING CODE P
