Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Nusachi Labs, LLC, 16031-16032 [2024-04743]
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<![CDATA[
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
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 9, 2024,
Sterling Pharma USA LLC., 10001
Sheldon Drive, Suite 101, Cary, North
Carolina 27513, applied to be registered
as a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Controlled substance
Tetrahydrocannabinols ....
5-Methoxy-N-Ndimethyltryptamine.
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7370
7431
I
I
7435
7437
7438
I
I
I
The company plans to manufacture
the above-listed controlled substance(s)
to support clinical trials. No other
activities for these drug codes are
authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
I
Schedule
9041
9180
II
II
I
[FR Doc. 2024–04754 Filed 3–5–24; 8:45 am]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: Stepan
Company
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Drug Enforcement Administration
[Docket No. DEA–1047]
Stepan Company 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 May 6, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 6, 2024.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Cocaine ...........................
Ecgonine ..........................
Drug
code
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[Docket No. DEA–1330]
16:57 Mar 05, 2024
Controlled
substance
The company plans to bulk
manufacture the listed controlled
substances for use as internal
intermediates or for sale to its
customers. No other activities for these
drug codes are authorized for this
registration.
[FR Doc. 2024–04747 Filed 3–5–24; 8:45 am]
VerDate Sep<11>2014
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 January 26, 2024,
Stepan Company, 100 West Hunter
Avenue, Maywood, New Jersey 07607–
1021, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
ADDRESSES:
Jkt 262001
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Nusachi
Labs, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
16031
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
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 6, 2024.
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: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
submit electronic comments on or
objections of the requested registration,
as provided in this notice. This notice
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
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.
E:\FR\FM\06MRN1.SGM
06MRN1
16032
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
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 June 13, 2022, Nusachi Labs, LLC,
2909 Armory Drive, Nashville,
Tennessee 37204, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
I
Drug
code
Schedule
7350
7360
7370
I
I
I
I
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 February 6, 2024,
Benuvia Operations, LLC, 3950 North
Mays Street, Round Rock, Texas 78665–
2729, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–04743 Filed 3–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1336]
Importer of Controlled Substances
Application: Benuvia Operations, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Benuvia Operations, 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.
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 April 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
April 5, 2024.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:57 Mar 05, 2024
Jkt 262001
Marihuana Extract ...........
Psilocyn ...........................
I
Drug
code
Schedule
7350
7438
I
I
I
The company plans to import the
listed controlled substances for clinical
trial manufacturing and analytical
purposes. sale to research facilities for
drug testing and analysis. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1331]
Bulk Manufacturer of Controlled
Substances Application: Organic
Consultants LLC DBA Cascade
Chemistry
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organic Consultants LLC DBA
Cascade Chemistry 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 May 6, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 6, 2024.
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 January 24, 2024,
Organic Consultants LLC DBA Cascade
Chemistry, 90 North Polk Street, Suite
200, Eugene, Oregon 97402–4109,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUMMARY:
[FR Doc. 2024–04757 Filed 3–5–24; 8:45 am]
Controlled
substance
BILLING CODE P
PO 00000
Amphetamine ...........................
Methylphenidate .......................
Codeine ....................................
Oxycodone ...............................
Hydromorphone .......................
Hydrocodone ............................
Meperidine ...............................
Meperidine intermediate-A .......
Frm 00064
Fmt 4703
Sfmt 4703
E:\FR\FM\06MRN1.SGM
06MRN1
Drug
code
1100
1724
9050
9143
9150
9193
9230
9232
Schedule
II
II
II
II
II
II
II
II
]]>Agencies
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16031-16032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04743]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1047]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Nusachi Labs, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is providing notice
of an application it has received from an entity applying to be
registered to manufacture in bulk basic class(es) of controlled
substances listed in schedule I. DEA intends to evaluate this and other
pending applications according to its regulations governing the program
of growing marihuana for scientific and medical research under DEA
registration.
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 6, 2024.
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: The Controlled Substances Act (CSA)
prohibits the cultivation and distribution of marihuana except by
persons who are registered under the CSA to do so for lawful purposes.
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is
providing notice that the entity identified below has applied for
registration as a bulk manufacturer of schedule I controlled
substances. In response, registered bulk manufacturers of the affected
basic class(es), and applicants therefor, may submit electronic
comments on or objections of the requested registration, as provided in
this notice. This notice does not constitute any evaluation or
determination of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical
ingredients 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.
[[Page 16032]]
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 June 13, 2022, Nusachi Labs, LLC, 2909 Armory Drive, Nashville,
Tennessee 37204, applied to be registered as a bulk manufacturer of the
following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-04743 Filed 3-5-24; 8:45 am]
BILLING CODE P
