[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76083-76084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26913]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1112]


Bulk Manufacturer of Controlled Substances Application: Sterling 
Pharma USA, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Sterling Pharma USA, 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 10, 2023. Such persons may also file a written request for a 
hearing on the application on or before February 10, 2023.

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

[[Page 76084]]

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 7, 2022, Sterling Pharma USA, LLC, 1001 
Sheldon Drive, Suite 101, Cary, North Carolina 27513-2078, 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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5-Methoxy-N-N-dimethyltryptamine........    7431  I
Psilocybin..............................    7437  I
Psilocyn................................    7438  I
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    The company plans to manufacture the above-listed controlled 
substances as clinical trials. No other activities for these drug codes 
are authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-26913 Filed 12-9-22; 8:45 am]
BILLING CODE P