80 FR 16 pg. 3982 - Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc.
Type: NOTICEVolume: 80Number: 16Page: 3982
Page: 3982Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2015-01315 Filed 1-23-15; 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: Siemens Healthcare Diagnostics, 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 March 27, 2015.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 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 section 7 of 28 CFR pt. 0, subpart. R, App.
In accordance with 21 CFR 1301.33(a), this is notice that on November 19, 2014, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 514, Newark, Delaware 19702, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| Controlled substance | Schedule |
|---|---|
| Tetrahydrocannabinols (7370) | I |
| Ecgonine (9180) | II |
| Morphine (9300) | II |
| Thebaine (9333) | II |
The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator controls which are DEA exempt products.
In reference to drug code 7370 the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01315 Filed 1-23-15; 8:45 am]
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