Importer of Controlled Substances Application: Cambrex Charles City, 52510-52511 [2015-21557]

Download as PDF 52510 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices [Docket No. DEA–392] implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters 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 section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on July 27, 2015, Catalent Pharma Solutions, LLC, 10381 Decatur Road, Philadelphia, Pennsylvania 19114 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for a clinical trial study. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on April 24, 2015, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, Illinois 60015 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Lysergic acid diethylamide (7315) Heroin (9200) ............................... Meperidine (9230) ........................ I I I II The company plans to import these controlled substances for the manufacture of reference standards. Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–21470 Filed 8–28–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: Controlled substance [FR Doc. 2015–21520 Filed 8–28–15; 8:45 am] Notice of application. BILLING CODE 4410–09–P 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 September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 tkelley on DSK3SPTVN1PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 16:19 Aug 28, 2015 Jkt 235001 Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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, dispensers importers, and exporters 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 section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on July 16, 2014, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601, applied to be registered as an importer of the following basic classes of controlled substances: Phenylacetone (8501) .................. Thebaine (9333) ........................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II II DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Noramco, 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 September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing DATES: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 The company plans to import thebaine (9333) analytical reference standards for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. The company plans to import phenylacetone (8501) and poppy straw concentrate (9670) to manufacture other controlled substances. Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–21545 Filed 8–28–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Cambrex Charles City ACTION: E:\FR\FM\31AUN1.SGM Notice of application. 31AUN1 52511 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices 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 September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). ADDRESSES: The Attorney General has delegated her 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, dispensers, importers, and exporters 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 section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on June 3, 2015, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616–3466 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES Controlled substance Schedule 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II II II 16:19 Aug 28, 2015 Jkt 235001 Controlled substance [FR Doc. 2015–21557 Filed 8–28–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Johnson Matthey Pharmaceutical Materials, Inc. ACTION: Notice of registration. Johnson Matthey Pharmaceutical Materials, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey Pharmaceutical Materials, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22559, Johnson Matthey Pharmaceutical Materials, Inc., 25 Patton Road, Devens, Massachusetts 01434 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Johnson Matthey Pharmaceutical Materials, Inc. to manufacture 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, 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. 823(a), 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: SUMMARY: Controlled substance The company plans to import the listed controlled substances for internal use, and to manufacture bulk intermediates for sale to its customers. VerDate Sep<11>2014 Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Amphetamine (1100) .................... Methylphenidate (1724) ................ Nabilone (7379) ............................ Hydrocodone (9193) ..................... Alfentanil (9737) ........................... PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Schedule II II II II II Remifentanil (9739) ...................... Sufentanil (9740) .......................... Schedule II II The company plans to utilize this facility to manufacture small quantities of the listed controlled substances in bulk and to conduct analytical testing in support of the company’s primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to its company’s customers. Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–21521 Filed 8–28–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies 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 1301.33(a) on or before October 30, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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, dispensers, importers, and exporters 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 DATES: E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Pages 52510-52511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21557]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Cambrex Charles 
City

ACTION: Notice of application.

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[[Page 52511]]


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 September 30, 2015. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 30, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. 
Comments and request for hearings on applications to import narcotic 
raw material are not appropriate. 72 FR 3417 (January 25, 2007).

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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, dispensers, importers, and exporters 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 section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on June 
3, 2015, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 
50616-3466 applied to be registered as an importer of the following 
basic classes of controlled substances:

 
------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Phenylacetone (8501).......................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
internal use, and to manufacture bulk intermediates for sale to its 
customers.

    Dated: August 21, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-21557 Filed 8-28-15; 8:45 am]
BILLING CODE 4410-09-P