Justia Regulation Tracker

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[Federal Register: June 26, 2009 (Volume 74, Number 122)]
[Notices]               
[Page 30621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn09-133]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
Importer of Controlled Substances; Notice of Application

    Pursuant to 21 USC 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 
1301.34(a), this is notice that on May 22, 2009, Noramco, Inc., 
Division of Ortho-McNeil, Inc., 500 Swedes Landing Road, Wilmington, 
Delaware 19801, 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 27, 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 
listed 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. E9-15233 Filed 6-25-09; 8:45 am]

BILLING CODE 4410-09-P