Importer of Controlled Substances Registration: STEPAN COMPANY, 34552-34553 [2014-14137]

Download as PDF 34552 Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.34(a), this is notice that on May 8, 2014, Alkermes Gainesville LLC, 1300 Gould Drive, Gainesville, Georgia 30504, applied to be registered as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for analytical research and testing. The import of the above listed basic class of controlled substance would be granted only for analytical testing and clinical testing. This authorization does not extend to the import of a finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.34(a), this is notice that on December 9, 2013, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523, applied to be registered as an importer of Nabilone (7379), a basic class of nonnarcotic controlled substance listed in schedule II. The company plans to import the FDA approved listed controlled substance as a finished drug product in dosage form for distribution to its customers. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–14145 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2014–14150 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Importer of Controlled Substances Application: MEDA PHARMACEUTICALS, INC. [Docket No. DEA–392] ACTION: Importer of Controlled Substances Registration: CODY LABORATORIES, INC. Notice of Application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before July 17, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 17, 2014. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. tkelley on DSK3SPTVN1PROD with NOTICES ADDRESS: The Attorney General has delegated his authority under the Controlled SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:43 Jun 16, 2014 Jkt 232001 ACTION: Notice of Registration. Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cody Laboratories, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1888, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414–9321, applied to be registered as an importer of certain basic classes of narcotic or non-narcotic controlled substances. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and SUMMARY: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 958(a) and determined that the registration of Cody Laboratories, 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verified the company’s compliance with state and local laws, and reviewed 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 narcotic or non-narcotic controlled substances listed: Controlled substance Phenylacetone (8501) .................. Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II The company plans to import narcotic raw materials for manufacturing and further distribution to its customers. The company is registered with the DEA as a manufacturer of several controlled substances that are manufactured from poppy straw concentrate. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacture tapentadol for distribution to its customers. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). In reference to the non-narcotic raw material, no comments or objections have been received. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–14151 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: STEPAN COMPANY ACTION: Notice of registration. Stepan Company applied to be registered as an importer of a basic class of a narcotic controlled substance. The DEA grants Stepan Company SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1 34553 Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated May 1, 2014, and published in the Federal Register on May 15, 2014, FR 79 27935, Stepan Company, Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey 07607, applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Stepan Company to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 Coca Leaves (9040), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to manufacture bulk controlled substance for distribution to its customers. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–14137 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P accordance with 21 CFR 1301.33(a) on or before August 18, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on May 4, 2014, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance 4-Anilino-N-phenethyl-4-piperidine (8333). Remifentanil (9739) ...................... Fentanyl (9801) ............................ Schedule II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Regarding the drug code (8333), the company plans to manufacture this listed controlled substance for commercial sale. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2014–14143 Filed 6–16–14; 8:45 am] tkelley on DSK3SPTVN1PROD with NOTICES Bulk Manufacturer of Controlled Substances Application: CEDARBURG PHARMACEUTICALS, INC. Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in VerDate Mar<15>2010 16:43 Jun 16, 2014 Jkt 232001 The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on May 21, 2014, AMPAC Fine Chemicals LLC, Highway 50 and Hazel Avenue, Building 05001, Rancho Cordova, California 95670, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Methylphenidate (1724) ................ Thebaine (9333) ........................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II II [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [Docket No. DEA–392] DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The company is a contract manufacturer. In reference to Poppy Straw Concentrate, the company will manufacture Thebaine intermediates for sale to its customers for further manufacture. No other activity for this drug code is authorized for this registration. BILLING CODE 4410–09–P ACTION: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before August 18, 2014. DATES: DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: PO 00000 Notice of Application. Frm 00068 Fmt 4703 Sfmt 9990 [FR Doc. 2014–14125 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Pages 34552-34553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14137]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: STEPAN COMPANY

ACTION: Notice of registration.

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SUMMARY: Stepan Company applied to be registered as an importer of a 
basic class of a narcotic controlled substance. The DEA grants Stepan 
Company

[[Page 34553]]

registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated May 1, 2014, and published 
in the Federal Register on May 15, 2014, FR 79 27935, Stepan Company, 
Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey 
07607, applied to be registered as an importer of a certain basic class 
of controlled substance.
    The Drug Enforcement Administration (DEA) has considered the 
factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the 
registration of Stepan Company to import the basic class of controlled 
substance is consistent with the public interest and with United States 
obligations under international treaties, conventions, or protocols in 
effect on May 1, 1971. The DEA investigated the company's maintenance 
of effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing 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 Coca Leaves (9040), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance to 
manufacture bulk controlled substance for distribution to its 
customers.
    Comments and request for hearings on applications to import 
narcotic raw material are not appropriate. 72 FR 3417 (January 25, 
2007).

    Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-14137 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P