[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75494-75495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30344]


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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

[[Page 75495]]

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 21 CFR 1301.34(a), this is notice 
that on June 4, 2010, 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 with 
the sole purpose of packaging, labeling, and distributing to customers 
which are qualified clinical sites conducting clinical trials under the 
auspices of an FDA-approved clinical study.
    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 January 3, 2011. 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 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: November 18, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-30344 Filed 12-2-10; 8:45 am]
BILLING CODE 4410-09-P