82 FR 23071 - Importer of Controlled Substances Application: Mallinckrodt LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 96 (May 19, 2017)

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23071-23072]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10242]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mallinckrodt LLC

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 June 19, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before June 19, 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 
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 hearing 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, dispenses, 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 21, 2016, Mallinckrodt LLC, 3600 North Second Street, Saint 
Louis, Missouri 63147 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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Marihuana..........................            7360  I

[[Page 23072]]

 
Phenylacetone......................            8501  II
Coca Leaves........................            9040  II
Opium, raw.........................            9600  II
Poppy Straw Concentrate............            9670  II
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    The company plans to import the listed controlled substances to 
bulk manufacture into Active Pharmaceutical Ingredients for 
distribution to its customers. Placement of these drug codes onto the 
company's registration does not translate into automatic approval of 
subsequent permit applications to import controlled substances.
    In reference to drug code 7360 (Marihuana) the company plans to 
import a synthetic cannabidiol. No other activity for this drug code is 
authorized for this registration.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10242 Filed 5-18-17; 8:45 am]
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