[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64158-64159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27036]


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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 on or before January 14, 2019. 
Such persons may also file a written request for a hearing on the 
application on or before January 14, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 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 
October 10, 2018, Mylan Pharmaceuticals Inc., 2898 Manufacturers Road, 
Greensboro, North Carolina 27406-4600 applied to be registered as an 
importer of the following basic class of controlled substance:

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                                           Drug
          Controlled substance             code          Schedule
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Nabilone...............................     7379  II
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    The company plans to import the FDA approved drug product in 
finished dosage form for distribution to its customers. 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).


[[Page 64159]]


    Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-27036 Filed 12-12-18; 8:45 am]
 BILLING CODE 4410-09-P