Importer of Controlled Substances Application: Noramco Inc., 64159-64160 [2018-27037]

Download as PDF 64159 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices Dated: December 3, 2018. John J. Martin, Assistant Administrator. Cocaine ......................... Codeine ......................... Dihydrocodeine .............. Oxycodone .................... Hydromorphone ............. Ecgonine ........................ Hydrocodone ................. Morphine ........................ Thebaine ........................ [FR Doc. 2018–27036 Filed 12–12–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories ACTION: Drug code Controlled substance 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 on or before February 11, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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, 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 November 22, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph.D., 5 Industrial Park Drive, Oxford, Mississippi 38655 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: 9041 9050 9120 9143 9150 9180 9193 9300 9333 Schedule II II II II II II II II II The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to isolate these controlled substances from procured 7350 (marihuana extract). In reference to drug code 7360 (marihuana), no cultivation activities are authorized for this registration. No other activities for these drug codes are authorized for this registration. Dated: December 3, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–27029 Filed 12–12–18; 8:45 am] 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 July 16, 2018, Cambrex High Point Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substances Oxymorphone ................ Noroxymorphone ........... Drug code 9652 9668 Schedule II II The company plans to manufacture the above listed controlled substances in bulk for distribution to its customers. Dated: December 3, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–27039 Filed 12–12–18; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P amozie on DSK3GDR082PROD with NOTICES1 SUPPLEMENTARY INFORMATION: Controlled substance Marihuana Extract ......... Marihuana ...................... Tetrahydrocannabinols .. Dihydromorphine ........... Amphetamine ................ Methamphetamine ......... VerDate Sep<11>2014 Drug code 7350 7360 7370 9145 1100 1105 17:12 Dec 12, 2018 Schedule I I I I II II Jkt 247001 DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc. ACTION: Notice of application. Frm 00063 Fmt 4703 Sfmt 4703 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 on or before January 14, 2019. Such persons may also file a written request for a hearing on the application on or before January 14, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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 on or before February 11, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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, dispensers, importers, and exporters of controlled substances (other than final orders in DATES: PO 00000 Drug Enforcement Administration E:\FR\FM\13DEN1.SGM 13DEN1 64160 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices 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, 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 August 14, 2018, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801–4417 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance amozie on DSK3GDR082PROD with NOTICES1 Marihuana ...................... Tetrahydrocannabinols .. Nabilone ........................ Phenylacetone ............... Opium, raw .................... Poppy Straw Concentrate. Tapentadol ..................... Drug code Schedule 7360 7370 7379 8501 9600 9670 I I II II II II 9780 II The company plans to import phenylacetone (8501), and poppy straw concentrate (9670) to bulk manufacture other controlled substances for distribution to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. Placement of these drug codes 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 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. VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 Dated: December 3, 2018. John J. Martin, Assistant Administrator. Vermont 05478 applied to be registered as an importer of the following basic classes of controlled substances: [FR Doc. 2018–27037 Filed 12–12–18; 8:45 am] Controlled substance BILLING CODE 4410–09–P Methylphenidate ............ Fentanyl ......................... DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Technologies, 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 on or before January 14, 2019. Such persons may also file a written request for a hearing on the application on or before January 14, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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, 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 November 7, 2018, Mylan Technologies Inc., 110 Lake Street, Saint Albans, DATES: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Drug code 1724 9801 Schedule 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 domestically manufactured FDF to foreign markets. Dated: December 3, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–27034 Filed 12–12–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On December 4, 2018, the Department of Justice lodged a proposed consent decree with the United States District Court for the Northern District of New York in the lawsuit entitled United States of America v. Grimmel Industries, LLC, et al., Civil Action No. 1:16–cv– 1103 (NAM/CFH). The United States filed the complaint in this Clean Water Act case against the Defendants on September 9, 2016. The complaint alleged that the Defendants, Grimmel Industries, LLC, Rensselaer Iron & Steel, Inc., and Toby Grimmel, violated the Multi-Sector General Permits issued by the New York Department of Environmental Conservation concurrently under Section 402(b) of the Clean Water Act, 42 U.S.C. 1342(b). The Complaint sought civil penalties and injunctive relief for eleven alleged violations of the permits, including effluent discharges in excess of permitted limits; failure to comply with corrective action requirements; inadequate permit coverage and stormwater pollution prevention plans; improper implementation of stormwater pollution prevention plans; failure to conduct quarterly visual monitoring; failure to timely submit reports; failure to perform annual dry weather flow monitoring; inadequate responses to benchmark exceedances; failure to train employees; E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64159-64160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27037]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Noramco Inc.

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 on or before January 14, 2019. 
Such persons may also file a written request for a hearing on the 
application on or before January 14, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

[[Page 64160]]


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, 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 August 
14, 2018, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 
19801-4417 applied to be registered as an importer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Nabilone...............................     7379  II
Phenylacetone..........................     8501  II
Opium, raw.............................     9600  II
Poppy Straw Concentrate................     9670  II
Tapentadol.............................     9780  II
------------------------------------------------------------------------

    The company plans to import phenylacetone (8501), and poppy straw 
concentrate (9670) to bulk manufacture other controlled substances for 
distribution to its customers. In reference to drug codes 7360 
(marihuana) and 7370 (THC), the company plans to import a synthetic 
cannabidiol and a synthetic tetrahydrocannabinol. No other activity for 
these drug codes is authorized for this registration. Placement of 
these drug codes 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 21 U.S.C 952(a)(2). Authorization will not extend to the import 
of FDA approved or non-approved finished dosage forms for commercial 
sale.

    Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-27037 Filed 12-12-18; 8:45 am]
 BILLING CODE 4410-09-P