[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Notices]
[Page 45779-45780]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au08-83]
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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 June 11, 2008, Almac Clinical Services Inc. (ACSI), 2661
Audubon Road, Audubon, Pennsylvania 19403, 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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Oxycodone (9143)............................ II
Fentanyl (9801)............................. II
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The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
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, VA 22152; and must be filed no later
than September 5, 2008.
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
[[Page 45780]]
in a previous notice published in the Federal Register on September 23,
1975 (40 FR 43745), 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: July 29, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E8-17976 Filed 8-4-08; 8:45 am]
BILLING CODE 4410-09-P