81 FR 68455 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 192 (October 4, 2016)

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68455-68456]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23887]


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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 3, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before November 3, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 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 June 
17, 2016, Fisher Clinical Services, Inc., 700 A-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 controlled 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)

[[Page 68456]]

to bulk manufacture tapentadol for distribution to its customers.

Louis J. Milione,
Assistant Administrator, Diversion Control Division.
[FR Doc. 2016-23887 Filed 10-3-16; 8:45 am]
 BILLING CODE 4410-09-P