Importer of Controlled Substances; Notice of Application, 55584-55585 [E9-26001]

Download as PDF 55584 Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices As explained in 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. 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 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 20, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–25905 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration erowe on DSK5CLS3C1PROD with NOTICES Importer of Controlled Substances; Notice of Application This is notice that on September 18, 2009, Clinical Supplies Management, 342 42nd Street South, Fargo, North Dakota 58103, made application to the Drug Enforcement Administration (DEA) for registration as an importer of Poppy Straw Concentrate (9670), a basic class of controlled substance listed in schedule II. The company plans to import an ointment for the treatment of wounds which contains trace amounts of controlled substances normally found in poppy straw concentrate which will be packaged and labeled for clinical trials. As explained in 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. 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 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 VerDate Nov<24>2008 15:34 Oct 27, 2009 Jkt 220001 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 16, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–25903 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P 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 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 21 CFR 1301.34(a), this is notice that on September 16, 2009, Hospira Inc., 1776 North Centennial Drive, McPherson, Kansas 67460–1247, made application 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 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, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 (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 21, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–26000 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P 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 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 September 4, 2009, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665–2402, made application via the Internet to the Drug Enforcement Administration (DEA) to be registered as an importer of 5Methoxy-N,N-diisopropyltryptamine (7439), a basic class of controlled substance listed in schedule I. The company plans to import small quantities of the listed controlled substance for the manufacture of analytical reference standards. Any bulk manufacturers who are presently, or are 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 E:\FR\FM\28OCN1.SGM 28OCN1 55585 Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than November 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: October 21, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–26001 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration commercial distribution. No other use of the imported material in question will be allowed. DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a) and determined that the registration of Mylan Pharmaceuticals Inc., to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Mylan Pharmaceuticals Inc. to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: October 16, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–25888 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P Importer of Controlled Substances; Notice of Registration By Notice dated June 3, 2009, and published in the Federal Register on June 9, 2009 (74 FR 27349), Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule erowe on DSK5CLS3C1PROD with NOTICES Methylphenidate (1724) ................ Fentanyl (9801) ............................. II II The company plans to import the listed controlled substances for analytical research and clinical trials. Two objections and one request for a hearing were received. The request for a hearing has been withdrawn. DEA has examined the other objections to the registration and has determined that the objections and comments received are not valid for this specific situation. The company will import finished dosage forms for clinical trials and analytical comparison only. They will not purchase raw material for the manufacture of finished goods and/or VerDate Nov<24>2008 15:34 Oct 27, 2009 Jkt 220001 investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: October 20, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–25891 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated June 3, 2009, and published in the Federal Register on June 9, 2009 (74 FR 27349), Mylan Technologies Inc., 110 Lake Street, Saint Albans, Vermont 05478, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: DEPARTMENT OF JUSTICE Drug Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated April 17, 2009, and published in the Federal Register on April 29, 2009, (74 FR 19598), Archimica, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807–1229, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Lisdexamfetamine (1205), a basic class of controlled substance listed in schedule II. The company plans to manufacture the controlled substance in bulk for distribution to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Archimica, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Archimica, Inc. to ensure that the company’s registration is consistent with the public interest. The PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Methylphenidate (1724) ................ Fentanyl (9801) ............................. Schedule II II The company plans to import the listed controlled substances for analytical research and clinical trials. Two objections and one request for a hearing were received. The request for a hearing has been withdrawn. DEA has examined the other objections to the registration and has determined that the objections and comments received are not valid for this specific situation. The company will import finished dosage forms for clinical trials and analytical comparison only. They will not purchase raw material for the manufacture of finished goods and/or commercial distribution. No other use of the imported material in question will be allowed. DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a) and determined that the registration of Mylan Pharmaceuticals Inc., to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55584-55585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26001]


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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 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 
(CFR), 1301.34(a), this is notice that on September 4, 2009, Cerilliant 
Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402, 
made application via the Internet to the Drug Enforcement 
Administration (DEA) to be registered as an importer of 5-Methoxy-N,N-
diisopropyltryptamine (7439), a basic class of controlled substance 
listed in schedule I.
    The company plans to import small quantities of the listed 
controlled substance for the manufacture of analytical reference 
standards.
    Any bulk manufacturers who are presently, or are 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

[[Page 55585]]

Administration, Office of Diversion Control, Federal Register 
Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 
22152; and must be filed no later than November 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: October 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-26001 Filed 10-27-09; 8:45 am]
BILLING CODE 4410-09-P

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