Manufacturer of Controlled Substances; Notice of Application, 64744-64745 [2010-26443]

Download as PDF 64744 Federal Register / Vol. 75, No. 202 / Wednesday, October 20, 2010 / Notices the Correction to Notice of Application pertaining to Rhodes Technologies, 72 FR 3417 (2007), comments and requests for hearings on applications to import narcotic raw material are not appropriate. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), 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, Virginia 22152; and must be filed no later than November 19, 2010. 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 classes 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: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–26454 Filed 10–19–10; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE emcdonald on DSK2BSOYB1PROD 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 bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. VerDate Mar<15>2010 17:17 Oct 19, 2010 Jkt 223001 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 21 CFR 1301.34(a), this is notice that on September 15, 2010, Hospira Inc., 1776 North Centennial Drive, McPherson, Kansas 67460–1247, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil for use in dosage form manufacturing. 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, Virginia 22152; and must be filed no later than November 22, 2010. 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 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: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–26445 Filed 10–19–10; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 August 20, 2010, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedule I: Drug Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Schedule I I The company plans to manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol. In reference to drug code 7370 (Tetrahydrocannabinols), the company will manufacture a synthetic THC. No other activity for this drug code is authorized for registration. 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 should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 20, 2010. Dated: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–26468 Filed 10–19–10; 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 September 14, 2010, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, made application by E:\FR\FM\20OCN1.SGM 20OCN1 64745 Federal Register / Vol. 75, No. 202 / Wednesday, October 20, 2010 / Notices renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of Cocaine (9041), a basic class of controlled substance listed in schedule II. 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 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 December 20, 2010. Dated: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Schedule Noroxymorphone (9668) .............. Tapentadol (9780) ........................ II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such 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 should be addressed, in quintuplicate, to the Drug Enforcement Administrator, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 20, 2010. Dated: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–26456 Filed 10–19–10; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2010–26443 Filed 10–19–10; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 20, 2010. Dated: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–26450 Filed 10–19–10; 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 August 20, 2010, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, 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 schedules I and II: Drug Enforcement Administration DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances; Notice of Application 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 12, 2010, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801– 4417, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: emcdonald on DSK2BSOYB1PROD with NOTICES Drug 17:17 Oct 19, 2010 Drug Schedule Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Morphine-N-oxide (9307) ............. Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Thebaine (9333) ........................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... VerDate Mar<15>2010 Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 7, 2010, National Center for Natural Products Research—NIDA MProject, University of Mississippi, 135 Coy Waller Lab Complex, University, Mississippi 38677, 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 I: I I I II II II II II II II II II II II II II II Jkt 223001 Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... I I The company plans to cultivate marihuana for the National Institute on Drug Abuse for research approved by the Department of Health and Human Services. 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 should be addressed, in PO 00000 Frm 00055 Fmt 4703 Sfmt 9990 Drug Dihydromorphine (9145) ............... Hydromorphone (9150) ................ Schedule I II Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. The company plans to manufacture Hydromorphone HCL for sale to other manufacturers and for the manufacture of other controlled substance dosage units for distribution 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 should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 20, 2010. Dated: October 8, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–26469 Filed 10–19–10; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 75, Number 202 (Wednesday, October 20, 2010)]
[Notices]
[Pages 64744-64745]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26443]


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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 September 14, 2010, GE 
Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004-
1412, made application by

[[Page 64745]]

renewal to the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of Cocaine (9041), a basic class of controlled substance 
listed in schedule II.
    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 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 December 20, 2010.

    Dated: October 8, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-26443 Filed 10-19-10; 8:45 am]
BILLING CODE 4410-09-P
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