Importer of Controlled Substances; Notice of Application, 46228 [E9-21541]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Page 46228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21541]


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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 July 8, 2009, 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, VA 22152; and must be filed no later 
than October 8, 2009.
    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: August 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-21541 Filed 9-4-09; 8:45 am]
BILLING CODE 4410-09-P