Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC, 16030-16031 [2024-04747]
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16030
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Dimethyltryptamine ..........
Cocaine ...........................
Methadone ......................
I
Drug
code
Schedule
7435
9041
9250
I
II
II
I
The company plans to import the
listed controlled substances for clinical
trials. 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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–04753 Filed 3–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 7, 2024,
Sigma Aldrich Company LLC, 3500
Dekalb Street, Saint Louis, Missouri
63118–4103, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
[Docket No. DEA–1332]
Importer of Controlled Substances
Application: Sigma Aldrich Company
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sigma Aldrich Company 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
submitting comments. Upon submission
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:57 Mar 05, 2024
Jkt 262001
Cathinone ........................
Methcathinone .................
Mephedrone (4-Methyl-Nmethylcathinone).
Gamma Hydroxybutyric
Acid.
Tetrahydrocannabinols ....
4-Bromo-2,5dimethoxyamphetamine.
4-Bromo-2,5dimethoxyphenethylamine.
2,5Dimethoxyamphetamine.
3,4Methylenedioxyamphetamine.
3,4-Methylenedioxy-Nethylamphetamine.
3,4Methylenedioxymethamphetamine.
4-Methoxyamphetamine ..
Dimethyltryptamine ..........
N-Benzylpiperazine .........
Heroin ..............................
Normorphine ....................
Amobarbital .....................
Secobarbital .....................
Nabilone ..........................
Phencyclidine ..................
Ecgonine ..........................
Ethylmorphine ..................
Levorphanol .....................
Meperidine .......................
Thebaine ..........................
Opium, powdered ............
PO 00000
Frm 00062
Fmt 4703
Drug
code
Schedule
1235
1237
1248
I
I
I
2010
I
7370
7391
I
I
7392
I
7396
I
7400
I
7404
I
7405
I
7411
7435
7493
9200
9313
2125
2315
7379
7471
9180
9190
9220
9230
9333
9639
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
Sfmt 4703
Controlled substance
Levo-alphacetylmethadol
Drug
code
Schedule
I 9648 III
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis. In reference to drug code 7370
(Tetrahydrocannabinols) the company
plans to import synthetic
Tetrahydrocannabinols. 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.
[FR Doc. 2024–04756 Filed 3–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1328]
Bulk Manufacturer of Controlled
Substances Application: Sterling
Pharma USA LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sterling Pharma 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 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
SUMMARY:
E:\FR\FM\06MRN1.SGM
06MRN1
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
]]>Agencies
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16030-16031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04747]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1328]
Bulk Manufacturer of Controlled Substances Application: Sterling
Pharma USA LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Sterling Pharma 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
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
[[Page 16031]]
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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................... 7370 I
5-Methoxy-N-N-dimethyltryptamine........ 7431 I
Dimethyltryptamine...................... 7435 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 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.
[FR Doc. 2024-04747 Filed 3-5-24; 8:45 am]
BILLING CODE P
