79 FR 116 pg. 34553 - Bulk Manufacturer of Controlled Substances Application: CEDARBURG PHARMACEUTICALS, INC.
Type: NOTICEVolume: 79Number: 116Page: 34553
Page: 34553Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2014-14143 Filed 6-16-14; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: CEDARBURG 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 in accordance with 21 CFR 1301.33(a) on or before August 18, 2014.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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, and dispensers 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 sec. 7(g) of 28 CFR pt. 0, subpt. R, App.
In accordance with 21 CFR 1301.33(a), this is notice that on May 4, 2014, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| Controlled substance | Schedule |
|---|---|
| 4-Anilino-N-phenethyl-4-piperidine (8333) | II |
| Remifentanil (9739) | II |
| Fentanyl (9801) | II |
The company plans to manufacture the listed controlled substances in bulk for distribution to its customers.
Regarding the drug code (8333), the company plans to manufacture this listed controlled substance for commercial sale.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-14143 Filed 6-16-14; 8:45 am]
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