Bulk Manufacturer of Controlled Substances Application: AJNA BioSciences, 87459 [2023-27707]
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87459
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
(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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–27708 Filed 12–15–23; 8:45 am]
BILLING CODE P
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 28, 2023,
Siegfried USA, LLC, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
Phenylacetone .................
Opium, raw ......................
Poppy Straw Concentrate
[Docket No. DEA–1307]
Importer of Controlled Substances
Application: Siegfried USA, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Siegfried USA, 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 17, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 17, 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. 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
I
Drug
code
Schedule
8501
9600
9670
II
II
II
I
The company plans to import the
listed controlled substances to
manufacture bulk Active
Pharmaceuticals Ingredients for
distribution to its customers. 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–27705 Filed 12–15–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1306]
Bulk Manufacturer of Controlled
Substances Application: AJNA
BioSciences
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Controlled substance
Psilocybin ........................
Psilocyn ...........................
I
Drug
code
Schedule
7437
7438
I
I
I
The company plans to bulk
manufacture by cultivating research
Good Manufacturing Practices whole
plant mushrooms containing Psilocybin
(7437) and Psilocyn (7438) to support
internal research, clinical trials, and
analytical purposes as well as to
distribute to their customers conducting
schedule I clinical research. No other
activities for these drug codes are
authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–27707 Filed 12–15–23; 8:45 am]
BILLING CODE P
AJNA BioSciences 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 16, 2024. Such
persons may also file a written request
SUMMARY:
for a hearing on the application on or
before February 16, 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 September 20, 2023,
AJNA BioSciences, 8022 Southpark
Circle, Suite 500, Littleton, Colorado
80120–5659, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1309]
Bulk Manufacturer of Controlled
Substances Application: Groff Health,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27707]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1306]
Bulk Manufacturer of Controlled Substances Application: AJNA
BioSciences
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: AJNA BioSciences 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 16, 2024. Such persons may also file a written request for a
hearing on the application on or before February 16, 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 September 20, 2023, AJNA BioSciences, 8022 Southpark
Circle, Suite 500, Littleton, Colorado 80120-5659, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to bulk manufacture by cultivating research Good
Manufacturing Practices whole plant mushrooms containing Psilocybin
(7437) and Psilocyn (7438) to support internal research, clinical
trials, and analytical purposes as well as to distribute to their
customers conducting schedule I clinical research. No other activities
for these drug codes are authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-27707 Filed 12-15-23; 8:45 am]
BILLING CODE P
