[Federal Register Volume 72, Number 153 (Thursday, August 9, 2007)]
[Notices]
[Page 44859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15512]


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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 
registration 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 18, 2007, 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
------------------------------------------------------------------------

    The company plans to import small quantities of the listed 
controlled substance 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 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 being sent via regular mail should 
be addressed, in quintuplicate, to the Drug Enforcement Administration, 
Office of Diversion Control, Federal Register Representative (ODL), 
Washington, DC 20537, or any being sent via express mail should be sent 
to Drug Enforcement Administration, Office of Diversion Control, 
Federal Register Representative (ODL), 2401 Jefferson Davis Highway, 
Alexandria, Virginia 22301; and must be filed no later than September 
10, 2007.
    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 
substances 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 31, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E7-15512 Filed 8-8-07; 8:45 am]
BILLING CODE 4410-09-P