[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Page 4021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01202]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1130]


Importer 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 
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 
February 22, 2023. Such persons may also file a written request for a 
hearing on the application on or before February 22, 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 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 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 December 1, 2022, Janssen Pharmaceuticals Inc., 1440 
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645, 
applied to be registered as an importer 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
Thebaine...............................     9333  II
Poppy Straw Concentrate................     9670  II
Tapentadol.............................     9780  II
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    The company plans to import intermediates classified under 
Tapentadol (9780) and Thebaine (9333) for further manufacturing to the 
controlled substances Tapentadol and Buprenorpine, respectively, prior 
to distribution to customers. The company plans to import Poppy Straw 
Concentrate (9670) to bulk manufacture other controlled substances. No 
other activity for this drug code is 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 non-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01202 Filed 1-20-23; 8:45 am]
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