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Almac Clinical Services Inc.
FR Doc E7-15512 [Federal Register: August 9, 2007 (Volume 72, Number 153)]
[Notices] [Page 44859] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au07-83]
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:
Drug
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Schedule
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Oxycodone (9143)
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II
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Fentanyl (9801)
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II
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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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
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