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Browse by Year / 2008 / October / Wednesday, October 08, 2008
[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Notices]               
[Page 58979]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc08-85]                         

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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 Title 21 Code of Federal Regulations 
(CFR), 1301.34(a), this is notice that on August 1, 2008, Clinical 
Supplies Management, Inc., 342 42nd Street, South Fargo, North Dakota 
58103, made application by renewal to the Drug Enforcement 
Administration (DEA) to be registered as an importer of Sufentanil 
(9740), a basic class of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance for 
clinical trials, research, and analytical purposes.
    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 should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than November 7, 2008.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR Sec.  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), all applicants 
for registration to import a basic class of any controlled substance in 
schedules 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: October 2, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E8-23817 Filed 10-7-08; 8:45 am]

BILLING CODE 4410-09-P

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