Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 97070 [2024-28719]
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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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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
Agencies
[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Notices]
[Page 97070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28719]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1464]
Bulk Manufacturer of Controlled Substances Application: Navinta
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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.
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
February 4, 2025. Such persons may also file a written request for a
hearing on the application on or before February 4, 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.
SUPPLEMENTARY INFORMATION: 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Levomethorphan.......................... 9210 II
Levorphanol............................. 9220 II
Remifentanil............................ 9739 II
------------------------------------------------------------------------
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-28719 Filed 12-5-24; 8:45 am]
BILLING CODE P