[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 4019-4020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01205]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1134]


Bulk Manufacturer of Controlled Substances Application: Janssen 
Pharmaceuticals Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Janssen Pharmaceuticals Inc., 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 
March 24, 2023. Such persons may also file a written request for a 
hearing on the application on or before March 24, 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 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

[[Page 4020]]

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 December 1, 2022, Janssen Pharmaceuticals Inc., 1440 
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645, 
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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Methylphenidate........................     1724  II
Hydromorphone..........................     9150  II
Hydrocodone............................     9193  II
Oripavine..............................     9330  II
Thebaine...............................     9333  II
Tapentadol.............................     9780  II
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    The company plans to bulk manufacture the listed controlled 
substances for the internal use intermediates or for sale to its 
customers. No other activities for these drug codes are authorized for 
this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01205 Filed 1-20-23; 8:45 am]
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