[Federal Register Volume 73, Number 54 (Wednesday, March 19, 2008)]
[Notices]
[Page 14839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5524]


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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) 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 21 CFR 1301.34(a), this is notice 
that on February 14, 2008, Roche Diagnostics Operations, Inc., Attn: 
Regulatory 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 basic classes of 
controlled substances listed in schedule I and II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide (7315)..........  I
Alphamethadol (9605).......................  I
Tetrahydrocannabinols (7370)...............  I
Cocaine (9041).............................  II
Ecgonine (9180)............................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
the manufacture of diagnostic products for distribution to its 
customers.
    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 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 being sent via regular mail should 
be addressed, in quintuplicate, to the Drug Enforcement Administration, 
Office of Diversion Control, Federal Register Representative (ODL), 
Washington, DC 20537, or any being sent via express mail should be sent 
to Drug Enforcement Administration, Office of Diversion Control, 
Federal Register Representative (ODL), 8701 Morrissette Drive, 
Springfield, VA 22152; and must be filed no later than April 18, 2008.
    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), all applicants for 
registration to import a basic class of any controlled substances 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: March 10, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E8-5524 Filed 3-18-08; 8:45 am]
BILLING CODE 4410-09-P