[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Page 65660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27032]
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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 21 CFR 1301.34(a), this is notice
that on July 9, 2010, Noramco, Inc., 1440 Olympic Drive, Athens,
Georgia 30601, 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 II:
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Drug Schedule
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Thebaine (9333)............................ II
Tapentadol (9780).......................... II
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The company plans to import Thebaine (9333) analytical reference
standards for distribution to its customers. The company plans to
import an intermediate form of Tapentadol (9780) to bulk manufacture
Tapentadol for distribution to its customers.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic class of controlled
substance 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 November 26, 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: October 15, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-27032 Filed 10-25-10; 8:45 am]
BILLING CODE 4410-09-P