[Federal Register: January 23, 2006 (Volume 71, Number 14)]
[Notices]
[Page 3545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja06-88]
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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 August 10, 2005, Clinical Trial Services (US), 2661 Audubon
Road, Audubon, Pennsylvania 19403, made application by renewal to the
Drug Enforcement Administration (DEA) to be registered as an importer
of Fentanyl (9801) and Oxycodone (9143), basic classes of controlled
substance listed in Schedule II.
The company plans to import small quantities of the listed
controlled substance in dosage form to conduct clinical trials.
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 February 22, 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 1301.34(b), (c), (d), (e) and (f) are satisfied.
Dated: January 11, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E6-717 Filed 1-20-06; 8:45 am]
BILLING CODE 4410-09-P