[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Page 14186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6411]
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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 January 21, 2010, 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 schedules I and
II:
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Drug Schedule
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Lysergic acid diethylamide (7315).......... I
Tetrahydrocannabinols (7370)............... I
Alphamethadol (9605)....................... I
Cocaine (9041)............................. II
Ecgonine (9180)............................ II
Methadone (9250)........................... II
Morphine (9300)............................ 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.
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 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 April 23, 2010.
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: March 16, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-6411 Filed 3-23-10; 8:45 am]
BILLING CODE 4410-09-P