Importer of Controlled Substances Application: ALKERMES GAINESVILLE LLC, 34551-34552 [2014-14145]

Download as PDF Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. Issued: June 12, 2014. Lisa R. Barton, Secretary to the Commission. Authority: This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission’s rules. BILLING CODE 7020–02–P [FR Doc. 2014–14146 Filed 6–16–14; 8:45 am] DEPARTMENT OF JUSTICE By order of the Commission. Issued: June 12, 2014. Lisa R. Barton, Secretary to the Commission. Drug Enforcement Administration [Docket No. DEA–392] [FR Doc. 2014–14148 Filed 6–16–14; 8:45 am] Importer of Controlled Substances Application: CATALENT CTS, LLC BILLING CODE 7020–02–P ACTION: INTERNATIONAL TRADE COMMISSION Silicon Metal From Russia Determination On the basis of the record 1 developed in the subject five-year review, the United States International Trade Commission (Commission) determines, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. § 1675(c)), that revocation of the antidumping duty order would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.2 tkelley on DSK3SPTVN1PROD with NOTICES Background The Commission instituted this review on June 3, 2013 (78 FR 33064) and determined on September 6, 2013 that it would conduct a full review (78 FR 61384, October 3, 2013). Notice of the scheduling of the Commission’s review and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register on December 19, 2013 (78 FR 76856). The hearing was cancelled, on April 7, 2014 (79 FR 19921, April 10, 2014). The Commission completed and filed its determination in this review on June 11, 2014. The views of the Commission are contained in USITC Publication 4471 (June 2014), entitled Silicon Metal from Russia: Investigation No. 731–TA– 991 (Second Review). By order of the Commission. 1 The record is defined in sec. 207.2(f) of the Commission’s Rules of Practice and Procedure (19 CFR § 207.2(f)). 2 Commissioner Rhonda K. Schmidtlein did not participate in the vote. 16:43 Jun 16, 2014 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: [Investigation No. 731–TA–991 (Second Review)] VerDate Mar<15>2010 Notice of application. Jkt 232001 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESS: 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 May 7, 2014, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, Missouri 64137, applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Marihuana (7360) ......................... Poppy Straw Concentrate (9670) PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Schedule I II 34551 The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form for a clinical trial study. In reference to drug code 7360, the company plans to import a synthetic cannabidiol. This compound is listed under drug code 7360. No other activity for this drug code is authorized for this registration. In addition, the company plans to import an ointment for the treatment of wounds which contain trace amounts of the controlled substances normally found in poppy straw concentrate for packaging and labeling to be used in clinical trials. Comments and requests 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. 2014–14123 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 Application: ALKERMES GAINESVILLE LLC 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 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. 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\17JNN1.SGM 17JNN1 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

Agencies

[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Pages 34551-34552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14145]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: ALKERMES 
GAINESVILLE LLC

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 
1301.34(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.

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

[[Page 34552]]

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.
[FR Doc. 2014-14145 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P