[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Page 75691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30549]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
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 in accordance with 21 CFR 
1301.34(a) on or before January 4, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before January 4, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/OD/D, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

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 
October 12, 2015, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, 
Morgantown, West Virginia 26505 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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Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
Fentanyl (9801)............................  II
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    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets.

    Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30549 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P