Importer of Controlled Substances Application: Mylan Technologies, Inc., 32316-32317 [2014-12945]

Download as PDF 32316 Federal Register / Vol. 79, No. 107 / Wednesday, June 4, 2014 / Notices may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 7, 2014. DEPARTMENT OF JUSTICE appropriate. 72 FR 3417 (January 25, 2007). Drug Enforcement Administration [Docket No. DEA–392] Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Importer of Controlled Substances Application: Penick Corporation Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12962 Filed 6–3–14; 8:45 am] ADDRESSES: 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 part 0, subpart R, App. In accordance with 21 CFR 1301.34(a), this is notice that on March 20, 2014, Actavis Pharma, Inc., 2455 Wardlow Road, Corona, California 92880–2882, applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ II II II II tkelley on DSK3SPTVN1PROD with NOTICES The company plans to import the listed controlled substances for analytical testing and clinical trials. The import of the above listed basic classes of controlled substances will be granted only for analytical testing and clinical trials. 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: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12976 Filed 6–3–14; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 16:05 Jun 03, 2014 Jkt 232001 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 1301.34(a) on or before July 7, 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 7, 2014. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 part 0, subpart R, App. In accordance with 21 CFR 1301.34(a), this is notice that on February 26, 2014, Penick Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070, applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Schedule II II The company plans to import the listed controlled substances to manufacture bulk controlled substance intermediates for sale to its customers. Comments and requests for any hearings on applications to import narcotic raw material are not PO 00000 BILLING CODE 4410–09–P Notice of application. Frm 00104 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Technologies, Inc. ACTION: 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 7, 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 7, 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 1301.34(a), this is notice that on December 12, 2013, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, applied to be registered as an importer of the following basic classes of controlled substances: DATES: Controlled Substance Methylphenidate (1724) ................ E:\FR\FM\04JNN1.SGM 04JNN1 Schedule II 32317 Federal Register / Vol. 79, No. 107 / Wednesday, June 4, 2014 / Notices Controlled Substance Schedule Fentanyl (9801) ............................ II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. In accordance with 21 CFR 1301.34(a), this is notice that on April 30, 2014, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, applied to be registered as an importer of Remifentanil (9739), a basic class controlled substance listed in schedule II. The company plans to import Remifentanil in bulk for use in dosage form manufacturing. Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12940 Filed 6–3–14; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2014–12945 Filed 6–3–14; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Importer of Controlled Substances Application: Rhodes Technologies [Docket No. DEA–392] ACTION: Importer of Controlled Substances Application: Akorn, Inc. ACTION: Registered bulk manufacturers of the affected basic class, 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 7, 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 7, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 part 0, subpart R, App. tkelley on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:05 Jun 03, 2014 Jkt 232001 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 7, 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 7, 2014. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 part 0, subpart R, App. In accordance with 21 CFR 1301.34(a), this is notice that on March SUPPLEMENTARY INFORMATION: PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 Controlled substance Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Schedule II II The company plans to import the listed controlled substances in order to bulk manufacture controlled substances in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured APIs in bulk to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). Dated: May 28, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–12950 Filed 6–3–14; 8:45 am] BILLING CODE 4410–09–P Notice of application. DATES: Notice of application. 12, 2014, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816, applied to be registered as an importer of the following basic classes of controlled substances: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Arizona Department of Corrections ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, 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 7, 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 7, 2014. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32316-32317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12945]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Technologies, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

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 
1301.34(a) on or before July 7, 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 7, 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 1301.34(a), this is notice that on 
December 12, 2013, Mylan Technologies, Inc., 110 Lake Street, Saint 
Albans, Vermont 05478, applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled Substance                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II

[[Page 32317]]

 
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets.

    Dated: May 28, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-12945 Filed 6-3-14; 8:45 am]
BILLING CODE 4410-09-P