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Federal Register
Notices > Importers >
Roche Diagnostics Operations, Inc.
FR Doc E6-9176 [Federal Register: June 13, 2006 (Volume 71, Number 113)]
[Notices] [Page 34162-34163] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn06-100]
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 26, 2006, Roche Diagnostics
Operations, Inc., Attn: Regulatory Compliance, 9115 Hague Road, Indianapolis
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 & II:
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Drug
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Schedule
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Lysergic acid diethylamide (7315)
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I
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Tetrahydrocannabinols (7370)
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I
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Cocaine (9041)
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II
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Ecgonine (9180)
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II
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Methadone (9250)
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II
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Morphine (9300)
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II
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Alphamethadol (9605)
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II
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The company plans to import the listed controlled substances for the
manufacture of diagnostic products for distribution to its customers.
[[Page 34163]]
The company plans to import the listed controlled substances for the
manufacture of controlled substances in bulk 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, DC 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 July 13,
2006.
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 301.34(b), (c), (d), (e) and (f) are satisfied.
Dated: June 7, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E6-9176 Filed 6-12-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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