[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]                         

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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)(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:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
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 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