Importer of Controlled Substances Application: Mylan Technologies, Inc., 64160 [2018-27034]

Download as PDF 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]
[Page 64160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27034]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Technologies, 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.

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, Vermont 05478 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Methylphenidate........................     1724  II
Fentanyl...............................     9801  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