[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42731-42732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18099]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II, and prior to issuing a 
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of 
such a substance, provide manufacturers holding registrations for the 
bulk manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with Title 21 Code of Federal Regulations 
(CFR), 1301.34(a), this is notice that on February 18, 2011, Roche 
Diagnostics Operations Inc., Attn: Import/Export Compliance, 9115 Hague 
Road, Indianapolis, Indiana 46250, made application by renewal to the 
Drug Enforcement Administration (DEA) to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Methaqualone (2565)........................  I
Lysergic acid diethylamide (7315)..........  I
Tetrahydrocannabinols (7370)...............  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Secobarbital (2315)........................  II
Phencyclidine (7471).......................  II
Codeine (9050).............................  II
Ecgonine (9180)............................  II
Methadone (9250)...........................  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
------------------------------------------------------------------------

    The company plans to import the listed controlled substances as a 
finished kit (for final use) products which will be distributed to its 
customers. The company will import the controlled substance in bulk or 
dispense form when needed for analytical testing purposes.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances may file comments or

[[Page 42732]]

objections to the issuance of the proposed registration, and may, at 
the same time, file a written request for a hearing on such application 
pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR 
1316.47.
    Any such comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than August 18, 2011.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR 1301.34(b), (c), 
(d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, (40 FR 43745-46), all 
applicants for registration to import a basic class of any controlled 
substance in schedule I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

    Dated: July 11, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-18099 Filed 7-18-11; 8:45 am]
BILLING CODE 4410-09-P