Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation, 5809 [2018-02638]
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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
]]>Agencies
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02638]
[[Page 5809]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application:
Cerilliant Corporation
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 April 10, 2018.
ADDRESSES: 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, 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 Schedule
------------------------------------------------------------------------
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1- 7010 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide).
MDMB-FUBINACA (Methyl 2-(1-(4- 7020 I
fluorobenzyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1- 7032 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H- 7033 I
indazole-3-carboxamido)-3-
methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5- 7034 I
fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1- 7042 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)- 7049 I
1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
U-47700 (3,4-dichloro-N-[2- 9547 I
(dimethylamino)cyclohexyl]-N-
methylbenzamide).
Acryl fentanyl (N-(1-phenethylpiperidin-4- 9811 I
yl)-N-phenylacrylamide).
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide).
Furanyl fentanyl (N-(1-phenethylpiperidin- 9834 I
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
