82 FR 13134 - Importer of Controlled Substances Application: Myoderm

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 45 (March 9, 2017)

[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13134-13135]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04646]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Myoderm

ACTION: Notice of application.

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[[Page 13135]]


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 April 10, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 10, 2017.

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 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 
November 11, 2016, Myoderm, 48 East Main Street, Norristown, 
Pennsylvania 19401 applied to be registered as an importer of the 
following basic classes of controlled substances:

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       Controlled substance           Drug code           Schedule
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Amphetamine......................            1100  II
Lisdexamfetamine.................            1205  II
Methylphenidate..................            1724  II
Nabilone.........................            7379  II
Oxycodone........................            9143  II
Hydromorphone....................            9150  II
Hydrocodone......................            9193  II
Morphine.........................            9300  II
Oxymorphone......................            9652  II
Fentanyl.........................            9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form for clinical trials, research, and analytical 
purposes.
    The import of the above listed basic classes of controlled 
substances will be granted only for analytical testing, research, and 
clinical trials. This authorization does not extend to the import of a 
finished FDA approved or non-approved dosage form for commercial sale.

Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-04646 Filed 3-8-17; 8:45 am]
 BILLING CODE 4410-09-P