Manufacturer of Controlled Substances; Notice of Application, 73358 [E7-25051]

Download as PDF 73358 Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices this is notice that on November 22, 2007, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Phenylacetone (8501) .................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Thebaine (9333) ........................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such substances may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written 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 February 25, 2008. Dated: December 17, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–25111 Filed 12–26–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE mstockstill on PROD1PC66 with NOTICES 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 VerDate Aug<31>2005 19:40 Dec 26, 2007 Jkt 214001 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 20, 2007, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of a substance controlled under the basic class of Cocaine (9041), a schedule II controlled substance. The company plans to manufacture a radioactive product used in diagnostic imaging in the diagnosis of Parkinson’s Disease and for manufacture in bulk for investigational new drug (IND) submission and clinical trials. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written 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 February 25, 2008. Dated: December 17, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control Drug Enforcement Administration. [FR Doc. E7–25051 Filed 12–26–07; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Page 73358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25051]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on July 20, 2007, GE Healthcare, 
3350 North Ridge Avenue, Arlington Heights, Illinois 60004-1412, made 
application to the Drug Enforcement Administration (DEA) to be 
registered as a bulk manufacturer of a substance controlled under the 
basic class of Cocaine (9041), a schedule II controlled substance.
    The company plans to manufacture a radioactive product used in 
diagnostic imaging in the diagnosis of Parkinson's Disease and for 
manufacture in bulk for investigational new drug (IND) submission and 
clinical trials.
    Any other such applicant and any person who is presently registered 
with DEA to manufacture such a substance may file comments or 
objections to the issuance of the proposed registration pursuant to 21 
CFR 1301.33(a).
    Any such written 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 February 25, 2008.

    Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control Drug 
Enforcement Administration.
 [FR Doc. E7-25051 Filed 12-26-07; 8:45 am]
BILLING CODE 4410-09-P
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