83 FR 8107 - Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 37 (February 23, 2018)

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Page 8107]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03723]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

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 March 26, 2018. Such 
persons may also file a written request for a hearing on the 
application March 26, 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 
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 
December 7, 2017, Mylan Pharmaceuticals Inc., 2898 Manufacturers Road, 
Greensboro, NC 27406 applied to be registered as an importer of 
Nabilone (7379), a basic class of controlled substance listed in 
Schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for commercial distribution purposes only. No 
other activity for this drug code is authorized for this registration. 
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). Authorization will not extend to the import of FDA approved 
or non-approved finished dosage forms for commercial sale.

    Dated: February 14, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-03723 Filed 2-22-18; 8:45 am]
 BILLING CODE 4410-09-P