[Federal Register Volume 74, Number 33 (Friday, February 20, 2009)]
[Notices]
[Pages 7923-7924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3650]


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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 January 16, 2009, Supernus 
Pharmaceuticals, Inc., 1550 East Gude Drive, Rockville, Maryland 20850, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as

[[Page 7924]]

an importer of the basic classes of controlled substances listed in 
schedule II:

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                    Drug                               Schedule
------------------------------------------------------------------------
Oxycodone (9143)............................  II
Morphine (9300).............................  II
------------------------------------------------------------------------

    The company plans to import controlled substances for clinical 
trials and analytical testing.
    Any bulk 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 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 March 23, 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 
substances 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: February 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-3650 Filed 2-19-09; 8:45 am]
BILLING CODE 4410-09-P