[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51642-51643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24201]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

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 on or before 
January 8, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. Comments and 
requests for hearings on applications to import 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 1301.33(a), this is notice that on June 
12, 2017, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 
50616 applied to be registered as a bulk manufacturer of the following 
basic classes of controlled substances:

 
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        Controlled substance            Drug code          Schedule
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Gamma Hydroxybutyric Acid..........            2010  I
Amphetamine........................            1100  II
Lisdexamfetamine...................            1205  II
Methylphenidate....................            1724  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Phenylacetone......................            8501  II
Cocaine............................            9041  II
Codeine............................            9050  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Hydrocodone........................            9193  II
Morphine...........................            9300  II
Oripavine..........................            9330  II
Thebaine...........................            9333  II
Opium extracts.....................            9610  II
Opium fluid extract................            9620  II
Opium tincture.....................            9630  II
Opium, powdered....................            9639  II
Oxymorphone........................            9652  II
Noroxymorphone.....................            9668  II
Fentanyl...........................            9801  II
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[[Page 51643]]

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers, for dosage form development, for 
clinical trials, and for use in stability qualification studies.

    Dated: October 30, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-24201 Filed 11-6-17; 8:45 am]
BILLING CODE 4410-09-P