Bulk Manufacturer of Controlled Substances Application: CEDARBURG PHARMACEUTICALS, INC., 34553 [2014-14143]

Download as PDF 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]
[Page 34553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14143]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: CEDARBURG 
PHARMACEUTICALS, INC.

ACTION: Notice of application.

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DATES: 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.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Remifentanil (9739)........................  II
Fentanyl (9801)............................  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.
[FR Doc. 2014-14143 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P