[Federal Register: April 4, 2005 (Volume 70, Number 63)]
[Notices]
[Page 17126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap05-138]

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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)(B) 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 January 5, 2005, Roche Diagnostics Operations Inc., Attention:
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 Schedules I and II:

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

    The company plans to import the listed controlled substances for
the manufacture of diagnostic products for distribution to its
customers.
    Any 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 written comments or objections being sent via regular mail
may be addressed, in quintuplicate, to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, D.C. 20537, Attention: DEA Federal Register
Representative, Liaison and Policy Section (ODL); or any being sent via
express mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 2401 Jefferson Davis Highway, Alexandria,
Virginia 22301; and must be filed no later than May 4, 2005.
    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 listed
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 25, 2005.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 05-6590 Filed 4-1-05; 8:45 am]

BILLING CODE 4410-09-P