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