Bulk Manufacturer of Controlled Substances Application: AJNA BioSciences, 87459 [2023-27707]

Download as PDF 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] BILLING CODE P 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]


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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.

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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
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