83 FR 64160 - Importer of Controlled Substances Application: Mylan Technologies, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 239 (December 13, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 239 (December 13, 2018)
| Page Range | 64160-64160 | |
| FR Document | 2018-27034 |
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)] [Notices] [Page 64160] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-27034] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan Technologies, Inc. ACTION: Notice of application. ----------------------------------------------------------------------- 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
![64160 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
SUPPLEMENTARY INFORMATION: The Dated: December 3, 2018. Vermont 05478 applied to be registered
Attorney General has delegated his John J. Martin, as an importer of the following basic
authority under the Controlled Assistant Administrator. classes of controlled substances:
Substances Act to the Administrator of [FR Doc. 2018–27037 Filed 12–12–18; 8:45 am]
the Drug Enforcement Administration Drug
BILLING CODE 4410–09–P Controlled substance Schedule
code
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with Methylphenidate ............ 1724 II
respect to the promulgation and DEPARTMENT OF JUSTICE Fentanyl ......................... 9801 II
implementation of 21 CFR part 1301,
incident to the registration of Drug Enforcement Administration
The company plans to import the
manufacturers, distributors, dispensers, [Docket No. DEA–392] listed controlled substances in finished
importers, and exporters of controlled dosage form (FDF) from foreign sources
substances (other than final orders in Importer of Controlled Substances for analytical testing and clinical trials
connection with suspension, denial, or Application: Mylan Technologies, Inc. in which the foreign FDF will be
revocation of registration) has been ACTION: Notice of application. compared to the company’s own
redelegated to the Assistant domestically-manufactured FDF. This
Administrator of the DEA Diversion DATES: Registered bulk manufacturers of analysis is required to allow the
Control Division (‘‘Assistant the affected basic classes, and company to export domestically
Administrator’’) pursuant to section 7 of applicants therefore, may file written manufactured FDF to foreign markets.
28 CFR part 0, appendix to subpart R. comments on or objections to the Dated: December 3, 2018.
In accordance with 21 CFR issuance of the proposed registration on John J. Martin,
1301.34(a), this is notice that on August or before January 14, 2019. Such Assistant Administrator.
14, 2018, Noramco Inc., 500 Swedes persons may also file a written request [FR Doc. 2018–27034 Filed 12–12–18; 8:45 am]
Landing Road, Wilmington, Delaware for a hearing on the application on or BILLING CODE 4410–09–P
19801–4417 applied to be registered as before January 14, 2019.
an importer of the following basic ADDRESSES: Written comments should
classes of controlled substances: be sent to: Drug Enforcement DEPARTMENT OF JUSTICE
Administration, Attention: DEA Federal
Drug Register Representative/DPW, 8701 Notice of Lodging of Proposed
Controlled substance Schedule Morrissette Drive, Springfield, Virginia Consent Decree Under the Clean Water
code
22152. All requests for hearing must be Act
Marihuana ...................... 7360 I sent to: Drug Enforcement
Tetrahydrocannabinols .. 7370 I Administration, Attn: Administrator, On December 4, 2018, the Department
Nabilone ........................ 7379 II 8701 Morrissette Drive, Springfield, of Justice lodged a proposed consent
Phenylacetone ............... 8501 II Virginia 22152. All requests for hearing decree with the United States District
Opium, raw .................... 9600 II should also be sent to: (1) Drug Court for the Northern District of New
Poppy Straw Con- 9670 II Enforcement Administration, Attn: York in the lawsuit entitled United
centrate. Hearing Clerk/OALJ, 8701 Morrissette States of America v. Grimmel Industries,
Tapentadol ..................... 9780 II Drive, Springfield, Virginia 22152; and LLC, et al., Civil Action No. 1:16–cv–
(2) Drug Enforcement Administration, 1103 (NAM/CFH).
The company plans to import Attn: DEA Federal Register The United States filed the complaint
phenylacetone (8501), and poppy straw Representative/DPW, 8701 Morrissette in this Clean Water Act case against the
concentrate (9670) to bulk manufacture Drive, Springfield, Virginia 22152. Defendants on September 9, 2016. The
other controlled substances for SUPPLEMENTARY INFORMATION: The complaint alleged that the Defendants,
distribution to its customers. In Attorney General has delegated his Grimmel Industries, LLC, Rensselaer
reference to drug codes 7360 authority under the Controlled Iron & Steel, Inc., and Toby Grimmel,
(marihuana) and 7370 (THC), the Substances Act to the Administrator of violated the Multi-Sector General
company plans to import a synthetic the Drug Enforcement Administration Permits issued by the New York
cannabidiol and a synthetic (DEA), 28 CFR 0.100(b). Authority to Department of Environmental
tetrahydrocannabinol. No other activity exercise all necessary functions with Conservation concurrently under
for these drug codes is authorized for respect to the promulgation and Section 402(b) of the Clean Water Act,
this registration. Placement of these implementation of 21 CFR part 1301, 42 U.S.C. 1342(b). The Complaint
drug codes onto the company’s incident to the registration of sought civil penalties and injunctive
registration does not translate into manufacturers, distributors, dispensers, relief for eleven alleged violations of the
automatic approval of subsequent importers, and exporters of controlled permits, including effluent discharges in
permit applications to import controlled substances (other than final orders in excess of permitted limits; failure to
substances. connection with suspension, denial, or comply with corrective action
revocation of registration) has been requirements; inadequate permit
Approval of permit applications will redelegated to the Assistant coverage and stormwater pollution
occur only when the registrant’s Administrator of the DEA Diversion prevention plans; improper
amozie on DSK3GDR082PROD with NOTICES1
business activity is consistent with what Control Division (‘‘Assistant implementation of stormwater pollution
is authorized under 21 U.S.C 952(a)(2). Administrator’’) pursuant to section 7 of prevention plans; failure to conduct
Authorization will not extend to the 28 CFR part 0, appendix to subpart R. quarterly visual monitoring; failure to
import of FDA approved or non- In accordance with 21 CFR timely submit reports; failure to perform
approved finished dosage forms for 1301.34(a), this is notice that on annual dry weather flow monitoring;
commercial sale. November 7, 2018, Mylan Technologies inadequate responses to benchmark
Inc., 110 Lake Street, Saint Albans, exceedances; failure to train employees;
VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/83_FR_64399/page/1.svg)
Document Created: 2018-12-13 01:16:19
Document Modified: 2018-12-13 01:16:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| 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. | |
| FR Citation | 83 FR 64160 |
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