[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2214-2215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00508]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Janssen 
Pharmaceuticals, Inc.

ACTION: Notice of application.

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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 on or before February 15, 2018. 
Such persons may also file a written request for a hearing on the 
application pursuant on or before February 15, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: 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

[[Page 2215]]

Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to 
subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
September 19, 2017, Janssen Pharmaceuticals Inc., 1400 Olympic Drive, 
BLDGS 1-5 & 7-14, Athens, Georgia 30601 applied to be registered as an 
importer of the following basic classes of controlled substances:

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                                           Drug
          Controlled substance             code          Schedule
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Tapentadol.............................     9780  II
Thebaine...............................     9333  II
Concentrated Poppy Straw...............     9670  II
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    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol for distribution to its 
customers. The company plans to import thebaine derivatives (9333) as 
reference standards. The company plans to import concentrated poppy 
straw to 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 FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: January 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-00508 Filed 1-12-18; 8:45 am]
 BILLING CODE 4410-09-P