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Federal Register
Notices > Importers >
Clinical Trial Services (US)
FR Doc E6-13846 [Federal Register: August 22, 2006 (Volume 71, Number 162)]
[Notices] [Page 48946-48947] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au06-84]
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 June 21, 2006, 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 the basic classes of controlled substances listed in Schedule II:
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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 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 should be
addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, Washington, DC 20537,
Attention: DEA Federal Register Representative/ODL; or any being sent via
express mail should be sent to DEA Headquarters, Attention:
[[Page 48947]]
DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway,
Alexandria, Virginia 22301; and must be filed no later than September 21, 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: August 15, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E6-13846 Filed 8-21-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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