[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