[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Page 58027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26507]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Janssen 
Pharmaceutical, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before February 6, 2018.

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

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
September 19, 2017, Janssen Pharmaceutical, Inc., Buildings 1-5 & 7-14, 
1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a 
bulk manufacturer of the following basic classes of controlled 
substances:

------------------------------------------------------------------------
               Controlled substance                Drug code   Schedule
------------------------------------------------------------------------
Methylphenidate..................................       1724         II
Oxycodone........................................       9143         II
Hydromorphone....................................       9150         II
Hydrocodone......................................       9193         II
Oripavine........................................       9330         II
Thebaine.........................................       9333         II
Oxymorphone......................................       9652         II
Tapentadol.......................................       9780         II
Fentanyl.........................................       9801         II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers.

    Dated: November 17, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-26507 Filed 12-7-17; 8:45 am]
 BILLING CODE 4410-09-P