[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Page 46956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17061]


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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 21 CFR 
1301.33(a) on or before September 19, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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 her 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 
Deputy Assistant Administrator of the DEA Office of Diversion Control 
(``Deputy 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 May 5, 
2016, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 
applied to be registered as a bulk manufacturer the following basic 
classes of controlled substances:

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                     Controlled Substance                       Schedule
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Amphetamine (1100)...........................................         II
Lisdexamfetamine (1205)......................................         II
Methylphenidate (1724).......................................         II
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333).............         II
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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    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.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-17061 Filed 7-18-16; 8:45 am]
 BILLING CODE 4410-09-P