Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Federal Register, Volume 79 Issue 195 (Wednesday, October 8, 2014)
Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)
Notices
Page 60864
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-24081
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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.
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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 1301.34(a) on or before November 7, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 7, 2014.
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 part 0, subpart R, App.
In accordance with 21 CFR 1301.34(a), this is notice that on December 13, 2013, Fisher Clinical Services, Inc., 700A-C Nestle Way, Breinigsville, Pennsylvania 18031-1522 applied to be registered as an importer of the following basic classes of controlled substances:
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Controlled substance Schedule
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Methylphenidate (1724)..................... II
Levorphanol (9220)......................... II
Noroxymorphone (9668)...................... II
Tapentadol (9780).......................... II
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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: October 1, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
FR Doc. 2014-24081 Filed 10-7-14; 8:45 am
BILLING CODE 4410-09-P
