[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Notices]               
[Page 56611-56612]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se08-103]                         

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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 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 August 18, 2008, GE 
Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004-
1412, made application by renewal to the Drug Enforcement 
Administration (DEA) to be registered as an importer of Cocaine (9041), 
a basic class of controlled substance listed in schedule II.
    The company plans to import small quantities of ioflupane, in the 
form of three separate analogues of Cocaine, to validate production and 
QC systems; for a reference standard; and for producing material for 
future investigational new drug (IND) submission.
    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

[[Page 56612]]

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 29, 2008.
    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), 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: September 22, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E8-22873 Filed 9-26-08; 8:45 am]

BILLING CODE 4410-09-P