Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 5809-5810 [2018-02637]
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5809
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cerilliant
Corporation
ACTION:
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 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,
ADDRESSES:
DEPARTMENT OF JUSTICE
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 April 10, 2018.
DATES:
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 July 19,
2017, Cerilliant Corporation, 811
Paloma Drive, Suite A, Round Rock,
Texas 78665–2402 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
Controlled substance
Drug code
ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .............
MDMB–FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ......................
MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ........
5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ..............................................
5F–ADB; 5F–MDMB–PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ......
MDMB–CHMICA, MMB–CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3dimethylbutanoate).
5F–APINACA, 5F–AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ..................................
U–47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) ..............................................................
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) .................................................................................
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) .........................................
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) .............................................................
The company plans to manufacture
small quantities of the listed controlled
substances to make reference standards
which will be distributed to its
customers.
Dated: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02638 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
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 March 12, 2018. Such persons
may also file a written request for a
hearing on the application on or before
March 12, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
sradovich on DSK3GMQ082PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:57 Feb 08, 2018
Jkt 244001
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.
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.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Schedule
7010
7020
7032
7033
7034
7042
I
I
I
I
I
I
7049
9547
9811
9824
9834
I
I
I
I
I
In accordance with 21 CFR
1301.34(a), this is notice that on
December 9, 2016, Mylan
Pharmaceuticals, Inc., 3711 Collins
Ferry Road, Morgantown, West Virginia
26505 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Amphetamine ...............
Methylphenidate ...........
Oxycodone ...................
Hydromorphone ............
Methadone ....................
Morphine .......................
Fentanyl ........................
Drug
code
1100
1724
9143
9150
9250
9300
9801
Schedule
II
II
II
II
II
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 domesticallymanufactured FDF to foreign markets.
Authorization will not extend to the
import of Food and Drug
Administration approved or nonapproved finished dosage forms for
commercial sale.
E:\FR\FM\09FEN1.SGM
09FEN1
5810
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Dated: February 2, 2018.
Susan A Gibson,
Deputy Assistant Administrator.
In accordance with 21 CFR
1301.34(a), this is notice that on July 6,
2017, Noramco, Inc., 1550 Olympic
Drive, Athens, Georgia 30601 applied to
be registered as an importer of the
following basic controlled substances:
[FR Doc. 2018–02637 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Noramco, Inc.
ACTION:
Notice of application.
Registered bulk manufacturer 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
March 12, 2018. Such persons may also
file a written request for a hearing on
the application on or before March 12,
2018.
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 requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
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.
sradovich on DSK3GMQ082PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:57 Feb 08, 2018
Jkt 244001
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
Nabilone .......................
Phenylacetone ..............
Thebaine .......................
Opium, raw ...................
Poppy Straw Concentrate.
Tapentadol ....................
Drug
code
Schedule
7350
7360
7370
7379
8501
9333
9600
9670
I
I
I
II
II
II
II
II
9780
II
The company plans to import
phenylacetone (8501), opium, raw
(9600), and poppy straw concentrate
(9670) to bulk manufacture other
controlled substances for distribution to
its customers. The company plans to
import an intermediate form of
tapentadol (9780) to bulk manufacture
tapentadol (9780) for distribution to its
customers. 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: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02646 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
Register Representative/DRW, 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 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
November 13, 2017, INSYS
Manufacturing LLC, 811 Paloma Drive,
Suite C, Round Rock, TX 78665–2402
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Marihuana .....................
Tetrahydrocannabinols
Drug
code
7360
7370
Schedule
I
I
The company plans to manufacture
the above listed controlled substances in
bulk for distribution to its customers.
In reference to drug codes 7360
(marihuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drug codes are
authorized for this registration.
Dated: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2018–02643 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: INSYS
Manufacturing LLC
ACTION:
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 April 10, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–392]
Notice of application.
DATES:
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Meridian Medical
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
DATES:
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5809-5810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02637]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals, 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 March 12, 2018. Such
persons may also file a written request for a hearing on the
application on or before March 12, 2018.
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.
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
December 9, 2016, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505 applied to be registered as an importer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Methylphenidate........................ 1724 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Methadone.............................. 9250 II
Morphine............................... 9300 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.
Authorization will not extend to the import of Food and Drug
Administration approved or non-approved finished dosage forms for
commercial sale.
[[Page 5810]]
Dated: February 2, 2018.
Susan A Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02637 Filed 2-8-18; 8:45 am]
BILLING CODE 4410-09-P
