Importer of Controlled Substances; Notice of Application, 55584-55585 [E9-26001]
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55584
Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
As explained in the Correction to
Notice of Application pertaining to
Rhodes Technologies, 72 FR 3417
(2007), comments and requests for
hearings on applications to import
narcotic raw material are not
appropriate.
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 class 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: October 20, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–25905 Filed 10–27–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
erowe on DSK5CLS3C1PROD with NOTICES
Importer of Controlled Substances;
Notice of Application
This is notice that on September 18,
2009, Clinical Supplies Management,
342 42nd Street South, Fargo, North
Dakota 58103, made application to the
Drug Enforcement Administration
(DEA) for registration as an importer of
Poppy Straw Concentrate (9670), a basic
class of controlled substance listed in
schedule II.
The company plans to import an
ointment for the treatment of wounds
which contains trace amounts of
controlled substances normally found in
poppy straw concentrate which will be
packaged and labeled for clinical trials.
As explained in the Correction to
Notice of Application pertaining to
Rhodes Technologies, 72 FR 3417
(2007), comments and requests for
hearings on applications to import
narcotic raw material are not
appropriate.
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 class 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
VerDate Nov<24>2008
15:34 Oct 27, 2009
Jkt 220001
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: October 16, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–25903 Filed 10–27–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on
September 16, 2009, Hospira Inc., 1776
North Centennial Drive, McPherson,
Kansas 67460–1247, made application
to the Drug Enforcement Administration
(DEA) to be registered as an importer of
Remifentanil (9739), a basic class of
controlled substance listed in schedule
II.
The company plans to import
Remifentanil for use in dosage form
manufacturing.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may 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 comments or objections
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than November 27, 2009.
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,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
(40 FR 43745), all applicants for
registration to import a basic class of
any controlled substance 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: October 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–26000 Filed 10–27–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with Title 21
Code of Federal Regulations (CFR),
1301.34(a), this is notice that on
September 4, 2009, Cerilliant
Corporation, 811 Paloma Drive, Suite A,
Round Rock, Texas 78665–2402, made
application via the Internet to the Drug
Enforcement Administration (DEA) to
be registered as an importer of 5Methoxy-N,N-diisopropyltryptamine
(7439), a basic class of controlled
substance listed in schedule I.
The company plans to import small
quantities of the listed controlled
substance for the manufacture of
analytical reference standards.
Any bulk manufacturers who are
presently, or are applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may 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 comments or objections
should be addressed, in quintuplicate,
to the Drug Enforcement
E:\FR\FM\28OCN1.SGM
28OCN1
55585
Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than November 27, 2009.
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 listed 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: October 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–26001 Filed 10–27–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
commercial distribution. No other use of
the imported material in question will
be allowed.
DEA has considered the factors in 21
U.S.C. 823(a) and § 952(a) and
determined that the registration of
Mylan Pharmaceuticals Inc., to import
the basic classes of controlled
substances is consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971, at this time. DEA has
investigated Mylan Pharmaceuticals Inc.
to ensure that the company’s
registration is consistent with the public
interest. The investigation has included
inspection and testing of the company’s
physical security systems, verification
of the company’s compliance with state
and local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
Dated: October 16, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–25888 Filed 10–27–09; 8:45 am]
BILLING CODE 4410–09–P
Importer of Controlled Substances;
Notice of Registration
By Notice dated June 3, 2009, and
published in the Federal Register on
June 9, 2009 (74 FR 27349), Mylan
Pharmaceuticals Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia
26505, made application by letter to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
the basic classes of controlled
substances listed in schedule II:
Drug
Schedule
erowe on DSK5CLS3C1PROD with NOTICES
Methylphenidate (1724) ................
Fentanyl (9801) .............................
II
II
The company plans to import the
listed controlled substances for
analytical research and clinical trials.
Two objections and one request for a
hearing were received. The request for
a hearing has been withdrawn. DEA has
examined the other objections to the
registration and has determined that the
objections and comments received are
not valid for this specific situation. The
company will import finished dosage
forms for clinical trials and analytical
comparison only. They will not
purchase raw material for the
manufacture of finished goods and/or
VerDate Nov<24>2008
15:34 Oct 27, 2009
Jkt 220001
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 823,
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: October 20, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–25891 Filed 10–27–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated June 3, 2009, and
published in the Federal Register on
June 9, 2009 (74 FR 27349), Mylan
Technologies Inc., 110 Lake Street, Saint
Albans, Vermont 05478, made
application to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the basic classes of
controlled substances listed in schedule
II:
DEPARTMENT OF JUSTICE
Drug
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated April 17, 2009, and
published in the Federal Register on
April 29, 2009, (74 FR 19598),
Archimica, Inc., 2460 W. Bennett Street,
Springfield, Missouri 65807–1229, made
application by letter to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
Lisdexamfetamine (1205), a basic class
of controlled substance listed in
schedule II.
The company plans to manufacture
the controlled substance in bulk for
distribution to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Archimica, Inc. to manufacture the
listed basic classes of controlled
substances is consistent with the public
interest at this time. DEA has
investigated Archimica, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Methylphenidate (1724) ................
Fentanyl (9801) .............................
Schedule
II
II
The company plans to import the
listed controlled substances for
analytical research and clinical trials.
Two objections and one request for a
hearing were received. The request for
a hearing has been withdrawn. DEA has
examined the other objections to the
registration and has determined that the
objections and comments received are
not valid for this specific situation. The
company will import finished dosage
forms for clinical trials and analytical
comparison only. They will not
purchase raw material for the
manufacture of finished goods and/or
commercial distribution. No other use of
the imported material in question will
be allowed.
DEA has considered the factors in 21
U.S.C. 823(a) and § 952(a) and
determined that the registration of
Mylan Pharmaceuticals Inc., to import
the basic classes of controlled
substances is consistent with the public
interest and with United States
obligations under international treaties,
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55584-55585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26001]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing a registration under this Section to a bulk manufacturer of a
controlled substance in schedule I or II, and prior to issuing a
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of
such a substance, provide manufacturers holding registrations for the
bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with Title 21 Code of Federal Regulations
(CFR), 1301.34(a), this is notice that on September 4, 2009, Cerilliant
Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402,
made application via the Internet to the Drug Enforcement
Administration (DEA) to be registered as an importer of 5-Methoxy-N,N-
diisopropyltryptamine (7439), a basic class of controlled substance
listed in schedule I.
The company plans to import small quantities of the listed
controlled substance for the manufacture of analytical reference
standards.
Any bulk manufacturers who are presently, or are applying to be,
registered with DEA to manufacture such basic class of controlled
substance may 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 comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement
[[Page 55585]]
Administration, Office of Diversion Control, Federal Register
Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia
22152; and must be filed no later than November 27, 2009.
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 listed 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: October 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-26001 Filed 10-27-09; 8:45 am]
BILLING CODE 4410-09-P
