80 FR 78766 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 242 (December 17, 2015)

[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Page 78766]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31672]


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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 January 19, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before January 19, 2016.

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 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 1301.34(a), this is notice that on August 
26, 2015, 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:

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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. Placement of these (this) drug code (s) onto the company's 
registration does not translate into automatic approval of subsequent 
permit applications to import controlled substances. Approval of permit 
applications will occur only when the registrant's business activity is 
consistent with what is authorized under to 21 U.S.C. 952(a)(2). 
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-31672 Filed 12-16-15; 8:45 am]
 BILLING CODE 4410-09-P