83 FR 39130 - Importer of Controlled Substances Application: Myoderm

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 153 (August 8, 2018)

[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Page 39130]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16938]


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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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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 September 7, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before September 7, 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 
request 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. 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 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 
October 5, 2017, Myoderm, 48 East Main St., Norristown, Pennsylvania 
19401 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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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
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    The company plans to import controlled substances commercially 
packaged in dosage form only for clinical trials purposes, research, 
and analytical purposes only.

    Dated: July 31, 2018.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2018-16938 Filed 8-7-18; 8:45 am]
 BILLING CODE 4410-09-P