Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc., 47109-47110 [2012-19197]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47109-47110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19197]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Clinical Supplies Management Inc.

    Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this 
is notice that on July 3, 2012, Clinical Supplies

[[Page 47110]]

Management Inc., 342 42nd Street South, Fargo, North Dakota 58103, made 
application by renewal to the Drug Enforcement Administration (DEA) for 
registration as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
                             Drug                               Schedule
------------------------------------------------------------------------
Methylphenidate (1724).......................................         II
Sufentanil (9740)............................................         II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
packaging, labeling, and distributing to customers which are qualified 
clinical sites, conducting FDA-approved clinical trials.
    The import of the above listed basic classes of controlled 
substances would be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
FDA approved or non-approved dosage form for commercial distribution in 
the United States.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedules I or II, which fall under the authority 
of section 1002(a)(2)(B) of the Act 21 U.S.C. 952(a)(2)(B) may, in the 
circumstances set forth in 21 U.S.C. 958(i), 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 Sec.  1301.43, and in such form as prescribed by 21 
CFR Sec.  1316.47.
    Any such written 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 September 6, 2012
    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 
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: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-19197 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P