[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Page 14290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05314]



[[Page 14290]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-982]


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 Supplemental 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 
May 13, 2022. Such persons may also file a written request for a 
hearing on the application on or before May 13, 2022.

ADDRESSES: DEA 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 December 10, 2021, Janssen Pharmaceuticals Inc., 1440 
Olympic Drive 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 manufacture the above-listed controlled 
substances in bulk for distribution to its customers. No other 
activities for these drug codes are authorized for this registration.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-05314 Filed 3-11-22; 8:45 am]
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