Importer of Controlled Substances Application: Fresenius Kabi USA, LLC, 57389 [2015-24118]
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Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
The company plans to import the
listed substances for analytical research,
testing, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial distribution in the United
States.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–24121 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chemtos,
LLC
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 in
accordance with 21 CFR 1301.33(a) on
or before November 23, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:00 Sep 22, 2015
Jkt 235001
In accordance with 21 CFR
1301.33(a), this is notice that on May 28,
2015, Chemtos, LLC, 14101 W. Highway
290, Building 2000B, Austin, Texas
78737–9331 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Marihuana (7360) .........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Etorphine HCI (9059) ...................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Ethylmorphine (9190) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Isomethadone (9226) ...................
Meperidine (9230) ........................
Meperidine intermediate-A (9232)
Meperidine intermediate-B (9233)
Meperidine intermediate-C (9234)
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Dihydroetorphine (9334) ...............
Levo-alphacetylmethadol (9648) ..
Oxymorphone (9652) ...................
Racemethorphan (9732) ..............
Racemorphan (9733) ...................
Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
small quantities of the listed controlled
substances in bulk for distribution to its
customers for use as reference
standards.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
57389
also file a written request for a hearing
on the application pursuant to 21 CFR
1301.43 on or before October 23, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
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
1301.34(a), this is notice that on June
16, 2015, Fresenius Kabi USA, LLC,
3159 Staley Road, Grand Island, New
York 14072 applied to be registered as
an importer of remifentanil (9739), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
listed controlled substance for product
development and preparation of
stability batches.
[FR Doc. 2015–24123 Filed 9–22–15; 8:45 am]
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2015–24118 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Importer of Controlled Substances
Application: Fresenius Kabi USA, LLC
[Docket No. DEA–392]
ACTION:
Importer of Controlled Substances
Registration: Rhodes Technologies
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.34(a) on or before
October 23, 2015. Such persons may
DATES:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
ACTION:
Notice of registration.
Rhodes Technologies applied
to be registered as an importer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Rhodes Technologies
SUMMARY:
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Page 57389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24118]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Fresenius Kabi
USA, LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.34(a) on or before October 23, 2015. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 23, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
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 1301.34(a), this is notice that on June
16, 2015, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New
York 14072 applied to be registered as an importer of remifentanil
(9739), a basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substance for
product development and preparation of stability batches.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24118 Filed 9-22-15; 8:45 am]
BILLING CODE 4410-09-P
