81 FR 45306 - Importer of Controlled Substances Application: Janssen Pharmaceutical, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 134 (July 13, 2016)

[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Notices]
[Pages 45306-45307]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16551]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Janssen 
Pharmaceutical, 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 in accordance with 21 CFR 
1301.34(a) on or before August 12, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before August 12, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417 (January 25, 2007).

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant 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 April 
11, 2016, Janssen Pharmaceutical, Inc., 1440 Olympic Drive, Athens, 
Georgia 30601 applied to be registered as an importer of the following 
basic classes of controlled substances:

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            Controlled substance                       Schedule
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Phenylacetone (8501).......................  II
Thebaine (9333)............................  II
Poppy Straw Concentrate (9670).............  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import thebaine derivatives (9333) as 
reference standards. The company plans to import an intermediate form 
of tapentadol (9780) to bulk manufacture tapentadol for distribution to 
its customers. The

[[Page 45307]]

company plans to import phenylacetone (8501) and poppy straw 
concentrate (9670) to manufacture other controlled substances.

    Dated: July 5, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-16551 Filed 7-12-16; 8:45 am]
 BILLING CODE 4410-09-P