[Federal Register Volume 74, Number 123 (Monday, June 29, 2009)]
[Notices]
[Page 31049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15234]


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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 May 22, 2009, Noramco, Inc., 
Division of Ortho-McNeil, Inc., 1440 Olympic Drive, Athens, Georgia 
30601, made application by letter to the Drug Enforcement 
Administration (DEA) to be registered as an importer of Tapentadol 
(9780), a basic class of controlled substance listed in schedule II.
    The company plans to import an intermediate of the basic class 
listed for the bulk manufacture of Tapentadol which it will distribute 
to its customers.
    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 July 29, 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: June 22, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-15234 Filed 6-26-09; 8:45 am]
BILLING CODE 4410-09-P