80 FR 16 pgs. 3979-3980 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Type: NOTICEVolume: 80Number: 16Pages: 3979 - 3980
Pages: 3979, 3980Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2015-01309 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]
Importer of Controlled Substances Application: Fisher Clinical Services, 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 1301.34(a) on or before February 25, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before February 25, 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 importers, 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, subpt. R, App.
[top] In accordance with 21 CFR 1301.34(a), this is notice that on June 16, 2014, Fisher Clinical Services, Inc. 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of the following basic classes of controlled substances:
| Controlled substance | Schedule |
|---|---|
| Methylphenidate (1724) | II |
| Levorphanol (9220) | II |
| Noroxymorphone (9668) | II |
| Tapentadol (9780) | II |
The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States.
The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01309 Filed 1-23-15; 8:45 am]
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