Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 95640-95641 [2016-31282]

Download as PDF 95640 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices Controlled substance Drug code Codeine ........................................................................................................................................................................... Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Morphine .......................................................................................................................................................................... The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers. Dated: December 20, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016–31284 Filed 12–27–16; 8:45 am] BILLING CODE 4410–09–P 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 DATES: or before January 27, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before January 27, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and request for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 October 14, 2016, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as an importer of the following basic classes of controlled substances: Drug code Phenylacetone ................................................................................................................................................................. Thebaine .......................................................................................................................................................................... Poppy Straw Concentrate ............................................................................................................................................... Tapentadol ....................................................................................................................................................................... sradovich on DSK3GMQ082PROD with NOTICES [FR Doc. 2016–31281 Filed 12–27–16; 8:45 am] BILLING CODE 4410–09–P 18:54 Dec 27, 2016 [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Navinta LLC 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 February 27, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. VerDate Sep<11>2014 Drug Enforcement Administration ACTION: Jkt 241001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 8501 9333 9670 9780 Schedule II II II II 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 19, 2016, Navinta LLC, 1499 SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE II II II II II SUPPLEMENTARY INFORMATION: Controlled substance The company plans to import thebaine derivatives (9333) as reference standards. 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. 9050 9143 9150 9193 9300 Schedule E:\FR\FM\28DEN1.SGM 28DEN1 95641 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices Lower Ferry Road, Ewing, New Jersey 08618–1414 applied to be registered as a bulk manufacturer of the following basic classes controlled substances: Controlled substance Drug code Pentobarbital .................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Remifentanil ..................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually up FDA approval to produce commercial size batches for distribution to dosage form manufacturers. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. Drug Enforcement Administration [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: Bulk Manufacturer of Controlled Substances Registration Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Company FR docket National Center for Natural Products Research (NIDA MPROJECT) .............. Cambrex Charles City ....................................................................................... Chemtos, LLC .................................................................................................... Stepan Company ............................................................................................... Chattem Chemicals ........................................................................................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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 each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. 80 81 81 81 81 FR FR FR FR FR 78766 46956 54604 54849 57932 Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Synthcon, 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 February 27, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: BILLING CODE 4410–09–P The Attorney General has delegated her authority under the Controlled Published ............................................ ............................................ ............................................ ............................................ ............................................ DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: [FR Doc. 2016–31280 Filed 12–27–16; 8:45 am] sradovich on DSK3GMQ082PROD with NOTICES The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUMMARY: BILLING CODE 4410–09–P Drug code 3-Fluoro-N-methylcathinone (3–FMC) ............................................................................................................................. Cathinone ........................................................................................................................................................................ Methcathinone ................................................................................................................................................................. 4-Fluoro-N-methylcathinone (4–FMC) ............................................................................................................................. Pentedrone (a-methylaminovalerophenone) ................................................................................................................... 18:54 Dec 27, 2016 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 December 17, 2015. July 19, 2016. August 16, 2016. August 17, 2016. August 24, 2016. 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 December 16, 2015, Synthcon, LLC, 770 Wooten Road, Unit 101, Colorado Springs, Colorado 80915 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance VerDate Sep<11>2014 II II II II Administration (DEA) as bulk manufacturers of various classes of controlled substances. DEPARTMENT OF JUSTICE ACTION: [FR Doc. 2016–31282 Filed 12–27–16; 8:45 am] 2270 8333 9739 9801 Schedule Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 1233 1235 1237 1238 1246 Schedule I I I I I

Agencies

[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95640-95641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31282]


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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 February 27, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 19, 2016, Navinta LLC, 1499

[[Page 95641]]

Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be registered 
as a bulk manufacturer of the following basic classes controlled 
substances:

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

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

    Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31282 Filed 12-27-16; 8:45 am]
BILLING CODE 4410-09-P