[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61248-61249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21240]


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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 therefor, may file written

[[Page 61249]]

comments on or objections to the issuance of the proposed registration 
in accordance with 21 CFR 1301.34(a) on or before October 6, 2016. Such 
persons may also file a written request for a hearing on the 
application pursuant to 21 CFR 1301.43 on or before October 6, 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., 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 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 this drug code 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.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-21240 Filed 9-2-16; 8:45 am]
 BILLING CODE 4410-09-P