[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Notices]
[Page 78149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26651]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-750]


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 file written comments on or objections to 
the issuance of the proposed registration on or before February 1, 
2021. Such persons may also file a written request for a hearing on the 
application on or before February 1, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(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 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-26651 Filed 12-2-20; 8:45 am]
BILLING CODE 4410-09-P