Importer of Controlled Substances; Notice of Registration; Catalent CTS, LLC, 69131-69132 [2013-27482]

Download as PDF 69131 Federal Register / Vol. 78, No. 222 / Monday, November 18, 2013 / Notices Schedule Drug mstockstill on DSK4VPTVN1PROD with NOTICES 1-Phenylcyclohexylamine (7460) 1-Piperidinocyclohexane carbonitrile (8603). Alphaprodine (9010) ..................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Noroxymorphone (9668) .............. Racemethorphan (9732) .............. Remifentanil (9739) ...................... Carfentanil (9743) ......................... Tapentadol (9780) ........................ DEPARTMENT OF JUSTICE II II Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration, Chattem Chemicals, Inc. Dated: November 5, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–27481 Filed 11–15–13; 8:45 am] II II II II II II II II II The company plans to import the listed controlled substances for manufacture and distribution to their research and forensic customers conducting drug testing and analysis. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substance listed in schedules I and II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 18, 2013. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic classes of any controlled substances in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: November 5, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–27454 Filed 11–15–13; 8:45 am] By Notice dated August 15, 2013, and published in the Federal Register on August 26, 2013, 78 FR 52801, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Schedule Methamphetamine (1105) ............ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ 17:33 Nov 15, 2013 Jkt 232001 II II II II The company plans to import the listed controlled substances to manufacture bulk controlled substances for sale to its customers. The company plans to import an intermediate form of Tapentadol (9780); and then to bulk manufacture Tapentadol for distribution to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Chattem Chemicals, 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. DEA has investigated Chattem Chemicals, Inc., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 controlled substances listed. BILLING CODE 4410–09–P VerDate Mar<15>2010 II II PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Catalent CTS, LLC By Notice dated August 15, 2013, and published in the Federal Register on August 26, 2013, 78 FR 53800, Catalent CTS, LLC., 10245 Hickman Mills Drive, Kansas City, Missouri 64137, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following classes of controlled substances: Drug Marihuana (7360) ......................... Poppy Straw Concentrate (9670) Schedule I II The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form for a clinical trial study. In addition, the company plans to import an ointment for the treatment of wounds which contains 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 any hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Catalent CTS, LLC., 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. DEA has investigated Catalent CTS, LLC., that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 controlled substances listed. E:\FR\FM\18NON1.SGM 18NON1 69132 Federal Register / Vol. 78, No. 222 / Monday, November 18, 2013 / Notices Dated: November 5, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–27482 Filed 11–15–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Noramco, Inc. By Notice dated August 14, 2013, and published in the Federal Register on August 21, 2013, 78 FR 51747, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug mstockstill on DSK4VPTVN1PROD with NOTICES [FR Doc. 2013–27457 Filed 11–15–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE II II II II Drug Enforcement Administration The company plans to import Thebaine (9333) analytical 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 the Phenylacetone (8501) in bulk for the manufacture of a controlled substance. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417(2007). In reference to the non-narcotic raw material, any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedules I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR 1316.47. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Noramco, Inc., to import the basic classes of controlled substances is consistent with the public interest and with United States 17:33 Nov 15, 2013 Dated: November 5, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Schedule Phenylacetone (8501) .................. Thebaine (9333) ........................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ VerDate Mar<15>2010 obligations under international treaties, conventions, or protocols in effect on May 1, 1971. DEA has investigated Noramco, Inc., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 controlled substances listed. Jkt 232001 Manufacturer of Controlled Substances, Notice of Application, National Center for Natural Products Research (NIDA MProject) Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 6, 2013, National Center for Natural Products Research—NIDA MProject, University of Mississippi, 135 Coy Waller Complex, University, Mississippi 38677, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... I I The company plans to cultivate marihuana in support of the National Institute on Drug Abuse for research approved by the Department of Health and Human Services. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 17, 2014. Dated: November 5, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–27491 Filed 11–15–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Johnson Matthey, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 5, 2013, Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Gamma Hydroxybutyric Acid (2010). Tetrahydrocannabinols (7370) ..... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Propiram (9649) ........................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Pages 69131-69132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27482]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; 
Catalent CTS, LLC

    By Notice dated August 15, 2013, and published in the Federal 
Register on August 26, 2013, 78 FR 53800, Catalent CTS, LLC., 10245 
Hickman Mills Drive, Kansas City, Missouri 64137, made application to 
the Drug Enforcement Administration (DEA) to be registered as an 
importer of the following classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import a finished pharmaceutical product 
containing cannabis extracts in dosage form for a clinical trial study. 
In addition, the company plans to import an ointment for the treatment 
of wounds which contains 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 any hearings on applications to import 
narcotic raw material are not appropriate. 72 FR 3417 (2007).
    DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and 
determined that the registration of Catalent CTS, LLC., 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. DEA has 
investigated Catalent CTS, LLC., that the company's registration is 
consistent with the public interest. The investigation has included 
inspection and testing of the company's physical security systems, 
verification of the company's compliance with state and local laws, and 
a review of 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 controlled substances listed.


[[Page 69132]]


     Dated: November 5, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-27482 Filed 11-15-13; 8:45 am]
BILLING CODE 4410-09-P