Importer of Controlled Substances, Notice of Application, Myoderm, 1887-1888 [2014-00202]
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1887
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
at least 68 underground storage tanks
(‘‘USTs’’) containing gasoline and waste
oil throughout Suffolk County. The
complaint seeks civil penalties and
injunctive relief for Suffolk’s violations
of Resource Conservation and Recovery
Act regulations governing USTs, set
forth at 40 CFR Part 280. The complaint
also alleges violation of federally
enforceable New York State hazardous
waste regulations set forth at 6
N.Y.C.R.R. § 372.2(a)(2) governing
disposal of spent fluorescent lamps. The
Consent Judgment requires Suffolk: (a)
to pay a civil penalty of $500,000; (b) to
fund a Supplemental Environmental
Project in the amount of $1,500,000 to
acquire an interest in land, and to
manage such land and any associated
ecological resources, into perpetuity, to
protect and/or enhance groundwater; (c)
to maintain compliance with RCRA
requirements for all of its underground
storage tanks and with NYS regulations
in its handling of spent fluorescent
lamps; and (d) to submit regular reports
to EPA for four years to demonstrate
that they are in compliance.
The publication of this notice opens
a period for public comment on the
Consent Judgment. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. County of Suffolk, D.J.
Ref. No. 90–7–1–09883. All comments
must be submitted no later than thirty
(30) days after the publication date of
this notice. Comments may be
submitted either by email or by mail:
To submit
comments:
Send them to:
By e-mail ......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
mstockstill on DSK4VPTVN1PROD with NOTICES
By mail .........
During the public comment period,
the Consent Judgment may be examined
and downloaded at this Justice
Department Web site: https://
www.usdoj.gov/enrd/Consent_
Decrees.html. We will provide a paper
copy of the Consent Judgment upon
written request and payment of
reproduction costs. Please mail your
request and payment to: Consent Decree
Library, U.S. DOJ–ENRD, P.O. Box 7611,
Washington, DC 20044–7611.
Please enclose a check or money order
for $15.75 (25 cents per page
VerDate Mar<15>2010
16:40 Jan 09, 2014
Jkt 232001
reproduction cost) payable to the United
States Treasury.
DEPARTMENT OF JUSTICE
Maureen Katz,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
Importer of Controlled Substances,
Notice of Application, Myoderm
[FR Doc. 2014–00182 Filed 1–9–14; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Siegfried USA,
LLC.
Pursuant to 21 CFR 1301.34 (a), this
is notice that on November 19, 2013,
Siegfried USA, LLC., 33 Industrial Park
Road, Pennsville, New Jersey 08070,
made application by renewal to the
Drug Enforcement Administration
(DEA) for registration as an importer of
the basic classes of controlled
substances:
Drug
Schedule
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
II
II
The company plans to import the
listed controlled substances to bulk
manufacture API’S for distribution to its
customer.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007)
As noted in a previous notice
published in the Federal Register on
September 23, 1975, 40 FR 43745, all
applicants for registration to import a
basic classes of any controlled
substances in schedule I or II are, and
will continue to be, required to
demonstrate to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: December 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–00201 Filed 1–9–14; 8:45 am]
BILLING CODE 4410–09–P
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Drug Enforcement Administration
Pursuant to 21 CFR 1301.34 (a), this
is notice that on October 28, 2013,
Myoderm, 48 East Main Street,
Norristown, Pennsylvania 19401, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration as an importer of the
following basic classes of controlled
substances:
Drug
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Nabilone (7379) ............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form for clinical trials, and
research.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical 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.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedules I or II,
which fall under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C. 952
(a)(2)(B)) may, in the circumstances set
forth in 21 U.S.C. 958(i), file comments
or objections to the issuance of the
proposed registration and may, at the
same time, file a written request for a
hearing on such application pursuant to
21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than February 10, 2014.
E:\FR\FM\10JAN1.SGM
10JAN1
1888
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedules I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: December 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–00202 Filed 1–9–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Cody
Laboratories, Inc.
Pursuant to 21 CFR 1301.34(a), this is
notice that on June 12, 2013, Cody
Laboratories Inc., 601 Yellowstone
Avenue, Cody, Wyoming 82414–9321,
made application by renewal to the
Drug Enforcement Administration
(DEA) for registration as an importer of
the following basic classes of controlled
substances:
substances listed in schedules I or II,
which fall under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C.
952(a)(2)(B)) may, in the circumstances
set forth in 21 U.S.C. 958(i), file
comments or objections to the issuance
of the proposed registration and may, at
the same time, file a written request for
a hearing on such application pursuant
to 21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than February 10, 2014.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substances in schedules
I or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
listed in schedules I or II, which fall
under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C.
952(a)(2)(B)) may, in the circumstances
set forth in 21 U.S.C. 958(i), file
comments or objections to the issuance
of the proposed registration and may, at
the same time, file a written request for
a hearing on such application pursuant
to 21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than February 10, 2014.
This procedure is to be conducted
simultaneously with and independent
of the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedules I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Phenylacetone (8501) ..................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
BILLING CODE 4410–09–P
II
II
II
DEPARTMENT OF JUSTICE
[FR Doc. 2014–00197 Filed 1–9–14; 8:45 am]
Drug Enforcement Administration
Drug
Dated: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
The company plans to import narcotic
raw materials for manufacturing and
further distribution to its customers.
The company is registered with DEA as
a manufacturer of several controlled
substances that are manufactured from
poppy straw concentrate.
The company plans to import an
intermediate form of Tapentadol (9780)
to bulk manufacture Tapentadol for
distribution to its customers.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007)
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
VerDate Mar<15>2010
19:00 Jan 09, 2014
Jkt 232001
[FR Doc. 2014–00203 Filed 1–9–14; 8:45 am]
Importer of Controlled Substances;
Notice of Application; Fresenius Kabi
USA, LLC.
Pursuant to 21 CFR 1301.34(a), this is
notice that on November 2, 2012,
Fresenius Kabi USA, LLC., 3159 Stanley
Road, Grand Island, New York 14072,
made application to the Drug
Enforcement Administration (DEA) for
registration as an importer of
Remifentanil (9739), a basic class of
controlled substance listed in schedule
II.
The company plans to import this
controlled substance for product
development and preparation of
stability batches.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated June 18, 2013, and
published in the Federal Register on
July 1, 2013, 78 FR 39336, Mylan
Pharmaceuticals, Inc., 3711 Collins
Ferry Road, Morgantown, West Virginia
26505, made application to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1887-1888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00202]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Application, Myoderm
Pursuant to 21 CFR 1301.34 (a), this is notice that on October 28,
2013, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401,
made application by renewal to the Drug Enforcement Administration
(DEA) for registration as an importer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Nabilone (7379)............................ II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Levomethorphan (9210)...................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form for clinical trials, and research.
The import of the above listed basic classes of controlled
substances will be granted only for analytical 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.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances listed in schedules I or II, which fall under the authority
of section 1002(a)(2)(B) of the Act (21 U.S.C. 952 (a)(2)(B)) may, in
the circumstances set forth in 21 U.S.C. 958(i), file comments or
objections to the issuance of the proposed registration and may, at the
same time, file a written request for a hearing on such application
pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR
1316.47.
Any such written comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODW), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than February 10, 2014.
[[Page 1888]]
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR 1301.34(b), (c),
(d), (e), and (f). As noted in a previous notice published in the
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants
for registration to import a basic class of any controlled substance in
schedules I or II are, and will continue to be, required to demonstrate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, that the requirements for such
registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR
1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: December 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2014-00202 Filed 1-9-14; 8:45 am]
BILLING CODE 4410-09-P
