Bulk Manufacturer of Controlled Substances Application: Navinta, LLC, 20418-20419 [2016-07948]

Download as PDF 20418 Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices 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 February 12, 2016, Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607 applied to be registered 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 in bulk for the manufacture of controlled substance for distribution to its customers. SUPPLEMENTARY INFORMATION: Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–07944 Filed 4–6–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Fisher Clinical Services, Inc. ACTION: Notice of registration. Fisher Clinical Services, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Fisher Clinical Services, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 9, 2015, and published in the Federal Register on December 17, 2015, 80 FR 78766, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:35 Apr 06, 2016 Jkt 238001 The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Fisher Clinical Services, 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, 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 the following basic classes of controlled substances: Controlled substance Methylphenidate (1724) ............. Levorphanol (9220) ................... Noroxymorphone (9668) ............ Tapentadol (9780) ..................... Schedule II II II II The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. Placement of these (this) drug code (s) onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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. Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–07945 Filed 4–6–16; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Navinta, 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 1301.33(a) on or before June 6, 2016. 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 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 1301.33(a), this is notice that on September 10, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Pentobarbital (2270) ............... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Remifentanil (9739) ................. Fentanyl (9801) ....................... Schedule II II II II The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually upon FDA approval to produce commercial size batches for distribution to dosage form manufacturers. E:\FR\FM\07APN1.SGM 07APN1 20419 Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. 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 the following basic classes of controlled substances: [FR Doc. 2016–07948 Filed 4–6–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled substance [Docket No. DEA–392] Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc. ACTION: Notice of registration. Mylan Pharmaceuticals, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 4, 2015, and published in the Federal Register on December 10, 2015, 80 FR 76709, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer 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, 952(a) and 958(a) and determined that the registration of Mylan Pharmaceuticals, 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, verifying the company’s compliance with state and SUMMARY: Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Morphine (9300) ........................... Oxymorphone (9652) ................... Remifentanil (9739) ...................... Fentanyl (9801) ............................ Schedule II II II II II II II II II II II 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: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–07946 Filed 4–6–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] VHG Labs DBA LGC Standards Warehouse applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants VHG Labs DBA LGC Standards Warehouse registration as an importer of those controlled substances. SUMMARY: By notice dated November 19, 2015, and published in the Federal Register on November 25, 2015, 80 FR 73830, VHG Labs DBA LGC Standards Warehouse 3 Perimeter Road, Manchester, New Hampshire 03103 applied to be registered as an importer 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, 952(a) and 958(a) and determined that the registration of VHG Labs DBA LGC Standards Warehouse 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, 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 the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Importer of Controlled Substances Registration: VHG Labs DBA LGC Standards Warehouse ACTION: Notice of registration. mstockstill on DSK4VPTVN1PROD with NOTICES Controlled substance Schedule 3-Fluoro-N-methylcathinone (3-FMC) (1233) .............................................................................................................................................. Cathinone (1235) ......................................................................................................................................................................................... Methcathinone (1237) .................................................................................................................................................................................. 4-Fluoro-N-methylcathinone (4-FMC) (1238) .............................................................................................................................................. Pentedrone (a-methylaminovalerophenone) (1246) .................................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... 4-Methyl-N-ethylcathinone (4-MEC) (1249) ................................................................................................................................................ Naphyrone (1258) ........................................................................................................................................................................................ N-Ethylamphetamine (1475) ........................................................................................................................................................................ N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. Fenethylline (1503) ...................................................................................................................................................................................... 4-Methylaminorex (cis isomer) (1590) ......................................................................................................................................................... Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... Methaqualone (2565) .................................................................................................................................................................................. Mecloqualone (2572) ................................................................................................................................................................................... JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) (6250) ................................................................................................................... SR-18 (Also known as RCS-8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) (7008) .................................................................. VerDate Sep<11>2014 16:35 Apr 06, 2016 Jkt 238001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\07APN1.SGM 07APN1 I I I I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)]
[Notices]
[Pages 20418-20419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07948]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Navinta, 
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 
1301.33(a) on or before June 6, 2016.

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 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 1301.33(a), this is notice that on 
September 10, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New 
Jersey 08618-1414 applied to be registered as a bulk manufacturer of 
the following basic classes of controlled substances:

------------------------------------------------------------------------
           Controlled substance                       Schedule
------------------------------------------------------------------------
Pentobarbital (2270).....................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)  II
 (8333).
Remifentanil (9739)......................  II
Fentanyl (9801)..........................  II
------------------------------------------------------------------------

    The company plans initially to manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval, 
then eventually upon FDA approval to produce commercial size batches 
for distribution to dosage form manufacturers.


[[Page 20419]]


    Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-07948 Filed 4-6-16; 8:45 am]
 BILLING CODE 4410-09-P