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GE Healthcare
FR Doc E7-25042 [Federal Register: December 27, 2007 (Volume 72, Number
247)] [Notices] [Page 73358] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de07-72]
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 registration 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 October 19, 2007, GE Healthcare, 3350 North
Ridge Avenue, Arlington Heights, Illinois 60004- 1412, made application to the
Drug Enforcement Administration (DEA) to be registered as an importer of a
substance controlled under the basic class of Cocaine (9041), a schedule II
controlled substance.
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 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 being sent via regular mail should be
addressed, in quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), Washington, DC
20537, or any being sent via express mail should be sent to Drug Enforcement
Administration, Office of Diversion Control, Federal Register Representative (ODL),
8701 Morrissette Drive, Springfield, VA 22152; and must be filed no later than
January 28, 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 43745-46), 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: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E7-25042 Filed 12-26-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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