[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):

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                                           Drug
          Controlled substance             code          Schedule
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Psilocybin..............................    7437  I
Psilocyn................................    7438  I
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    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]
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