[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Notices]
[Pages 45779-45780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17976]


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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
------------------------------------------------------------------------
Oxycodone (9143)............................  II
Fentanyl (9801).............................   II
------------------------------------------------------------------------

    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