[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Page 78363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26653]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-751]


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 
Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before January 4, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before January 4, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on November 11, 2020, Janssen Pharmaceuticals Inc., 1440 
Olympic Drive, 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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          Controlled substance               Drug code       Schedule
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Thebaine................................            9333              II
Poppy Straw Concentrate.................            9670              II
Tapentadol..............................            9780              II
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    The company plans to import intermediate forms of Tapentadol (9780) 
and Thebaine (9333) for further manufacturing prior to distribution to 
its customers. The company plans to import Poppy Straw Concentrate 
(9670) to bulk manufacture other controlled substances. No other 
activity for these drug codes 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-26653 Filed 12-3-20; 8:45 am]
BILLING CODE 4410-09-P