Importer of Controlled Substances Application: Organic Standards Solutions International, LLC, 97070-97071 [2024-28717]
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97070
Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices
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 November 5, 2024,
Kinetochem LLC, 96 Market Street,
Suite 102, Georgetown, Texas 78626–
3618, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled
substance
Marihuana ..................
Tetrahydrocannabinols.
Psilocybin ..................
Psilocyn .....................
Drug
code
Schedule
7360
7370
I
I
7437
7438
I
I
The company plans to bulk
manufacture the listed controlled
substances as Active Pharmaceutical
Ingredients to its customers as well as
for research and clinical trials. In
reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols) the company
plans to bulk manufacture these drug
codes as synthetic. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
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 4, 2025. Such
persons may also file a written request
for a hearing on the application on or
before February 4, 2025.
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 October 14, 2024,
Navinta LLC, 1499 Lower Ferry Road,
Ewing, New Jersey 08618–1414, applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Levomethorphan ..............
Levorphanol .....................
Remifentanil .....................
Drug
code
Schedule
9210
9220
9739
II
II
II
[FR Doc. 2024–28715 Filed 12–5–24; 8:45 am]
BILLING CODE 4410–09–P
The company plans to bulk
manufacture the listed controlled
substances for validation purposes as
part of the Food Administration
approval process before distributing to
their customers. No other activities for
these drug codes are authorized for this
registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1464]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
lotter on DSK11XQN23PROD with NOTICES1
AGENCY:
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–28719 Filed 12–5–24; 8:45 am]
BILLING CODE P
Navinta 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.
SUMMARY:
VerDate Sep<11>2014
18:02 Dec 05, 2024
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PO 00000
Frm 00135
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1465]
Importer of Controlled Substances
Application: Organic Standards
Solutions International, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organic Standards Solutions
International, 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 January 6, 2025. Such
persons may also file a written request
for a hearing on the application on or
before January 6, 2025.
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 November 6, 2024,
Organic Standards Solutions
International, LLC, 7290 Investment
Drive, Unit B, North Charleston, South
DATES:
E:\FR\FM\06DEN1.SGM
06DEN1
Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices
Carolina 29418–8305, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
Psilocybin ........................
Psilocyn ...........................
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 October 9, 2024,
Noramco, 500 Swedes Landing Road,
Wilmington, Delaware 19801–4417,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
ADDRESSES:
Drug
code
Schedule
7350
7360
7370
7437
7438
I
I
I
I
I
The company plans to import the
listed controlled substances to produce
analytical reference standards for sale
and distribution to its customers. Drug
codes 7350 (Marihuana Extract) and
7360 (Marihuana) will be used for the
manufacture of cannabidiol only. In
reference to drug code 7370
(Tetrahydrocannabinols) the company
plans to import a synthetic version of
this controlled substance. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–28717 Filed 12–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Controlled substance
Drug
code
Schedule
2010
I
7360
7370
9254
9600
9610
9620
9630
9639
9640
9650
I
I
II
II
II
II
II
II
II
II
9668
9670
9780
II
II
II
Drug Enforcement Administration
[Docket No. DEA–1462]
Importer of Controlled Substances
Application: Noramco
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Noramco 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 January 6, 2025. Such
persons may also file a written request
for a hearing on the application on or
before January 6, 2025.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:02 Dec 05, 2024
Jkt 265001
Gamma Hydroxybutyric
Acid.
Marihuana ........................
Tetrahydrocannabinols ....
Methadone-Intermediate
Opium, Raw .....................
Opium Extracts ................
Opium Fluid Extract .........
Opium Tincture ................
Opium, Powdered ............
Opium, Granulated ..........
Opium Poppy/Poppy
Straw.
Noroxymorphone .............
Poppy Straw Concentrate
Tapentadol ......................
The company plans to import Poppy
Straw Concentrate (9670) to bulk
manufacture other controlled substances
for distribution to its customers. The
company plans to import an
intermediate form of Tapentadol (9780)
to bulk manufacture Tapentadol for
distribution to its customers. In
reference to drug codes 7360
PO 00000
Frm 00136
Fmt 4703
Sfmt 4703
97071
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to import a synthetic cannabidiol
and a synthetic Tetrahydrocannabinol.
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–28728 Filed 12–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On December 2, 2024, the Department
of Justice lodged a proposed Consent
Decree with the United States District
Court for the Western District of
Missouri in the lawsuit entitled United
States of America v. BCP Ingredients,
Inc. Civ. No. 3:24–cv–5094 (W.D. Mo.).
The Complaint seeks injunctive relief
and civil penalties for alleged violations
of section 112(r) of the Federal Clean
Air Act (‘‘CAA’’), 42 U.S.C. 7412(r)(7),
and its implementing regulations set
forth at 40 CFR part 68, resulting from
a release of ethylene oxide (‘‘EtO’’) at a
chemical manufacturing and repackaging facility owned and operated
by BCP Ingredients, Inc. (‘‘BCP’’) in
Verona, Missouri. Under the proposed
Consent Decree resolving these alleged
violations, BCP will pay a civil penalty
of $300,000 to the United States, install
an additional state-of-the-art EtO
scrubber to reduce EtO emissions at its
facility, and share a copy of its final
audit completion report from a 2022
third party audit. BCP also will be
required to perform three Supplemental
Environmental Projects totaling
$350,000: (1) donation of two vehicles
to a local healthcare provider to provide
mobile health services to communities
near BCP’s facility; (2) provision of at
least 1,000 medical visits to be
administered by the same local
healthcare provider using the vehicles
BCP will donate for the first SEP; and
(3) donation of emergency response
equipment to a fire department near
BCP’s facility.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
E:\FR\FM\06DEN1.SGM
06DEN1
]]>Agencies
[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Notices]
[Pages 97070-97071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28717]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1465]
Importer of Controlled Substances Application: Organic Standards
Solutions International, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Organic Standards Solutions International, 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
January 6, 2025. Such persons may also file a written request for a
hearing on the application on or before January 6, 2025.
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 November 6, 2024, Organic Standards Solutions
International, LLC, 7290 Investment Drive, Unit B, North Charleston,
South
[[Page 97071]]
Carolina 29418-8305, applied to be registered as an importer of the
following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances to
produce analytical reference standards for sale and distribution to its
customers. Drug codes 7350 (Marihuana Extract) and 7360 (Marihuana)
will be used for the manufacture of cannabidiol only. In reference to
drug code 7370 (Tetrahydrocannabinols) the company plans to import a
synthetic version of this controlled substance. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-28717 Filed 12-5-24; 8:45 am]
BILLING CODE P
