Importer of Controlled Substances; Notice of Application, 51399-51400 [2011-21068]
Download as PDF
51399
Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
No comments, objections, or requests
for any hearings will be accepted on any
application for registration or reregistration to import crude opium,
poppy straw, concentrate of poppy
straw, and coca leaves. 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.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule 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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than September 19, 2011.
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, 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: August 11, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–21117 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
VerDate Mar<15>2010
16:04 Aug 17, 2011
Jkt 223001
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 May 4,
2011, Cambrex Charles City, 1205 11th
Street, Charles City, Iowa 50616–3466,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
Noroxymorphone (9668), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
basic class of controlled substance in
bulk for sale to its customers.
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 written 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 September 19, 2011.
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, 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.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Dated: August 10, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–21121 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to Title 21, of the CFR
1301.34(a), this is notice that on June 8,
2011, Aptuit, 10245 Hickman Mills
Drive, Kansas City, Missouri 64137,
made application by renewal to the
Drug Enforcement Administration
(DEA) for registration as an importer of
the following basic classes of controlled
substances:
Drug
Marihuana (7360) .........................
Poppy Straw Concentrate (9670)
Schedule
I
II
The company plans to import a
finished pharmaceutical product
containing cannabis extracts in dosage
form for packaging for a clinical trial
study. In addition, the company also
plans to import an ointment for the
treatment of wounds which contain
trace amounts of the controlled
substances normally found in poppy
straw concentrate for packaging and
labeling for clinical trials.
No comments, objections, or requests
for any hearings will be accepted on any
application for registration or reregistration to import crude opium,
poppy straw, concentrate of poppy
straw or coca leaves. 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.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule 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.
E:\FR\FM\18AUN1.SGM
18AUN1
51400
Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
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 September 19, 2011.
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, 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: August 9, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–21068 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated May 13, 2011, and
published in the Federal Register on
May 27, 2011, 76 FR 30968, Almac
Clinical Services Inc., (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
Schedule
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
II
II
II
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Almac Clinical Services Inc. (ACSI) 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. DEA has investigated
Almac Clinical Services Inc. (ACSI) 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: August 11, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–21077 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By a Notice dated April 28, 2011, and
published in the Federal Register on
May 4, 2011 76 FR 25374, Rhodes
Technologies, 498 Washington Street,
Coventry, Rhode Island 02816, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Raw Opium (9600) ..............................................................................................................................
Concentrate of Poppy Straw (9670) ....................................................................................................
The company plans to import the
listed controlled substances in order to
bulk manufacture controlled substances
in Active Pharmaceutical Ingredient
(API) form. The company distributes the
manufactured API’s in bulk form only to
its customers.
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.
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a), and
determined that the registration of
Rhodes Technologies to import the basic
classes of controlled substances is
consistent with the public interest, and
with United States obligations under
international treaties, conventions, or
VerDate Mar<15>2010
16:04 Aug 17, 2011
Jkt 223001
protocols in effect on May 1, 1971. DEA
has investigated Rhodes Technologies 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.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
II
II
Dated: August 11, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–21076 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on June 17, 2011,
Cambridge Isotope Lab, 50 Frontage
Road, Andover, Massachusetts 01810,
made application by renewal to the
E:\FR\FM\18AUN1.SGM
18AUN1
Agencies
[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51399-51400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21068]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to Title 21, of the CFR 1301.34(a), this is notice that on
June 8, 2011, Aptuit, 10245 Hickman Mills Drive, Kansas City, Missouri
64137, 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
------------------------------------------------------------------------
Marihuana (7360)........................... I
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
The company plans to import a finished pharmaceutical product
containing cannabis extracts in dosage form for packaging for a
clinical trial study. In addition, the company also plans to import an
ointment for the treatment of wounds which contain trace amounts of the
controlled substances normally found in poppy straw concentrate for
packaging and labeling for clinical trials.
No comments, objections, or requests for any hearings will be
accepted on any application for registration or re-registration to
import crude opium, poppy straw, concentrate of poppy straw or coca
leaves. 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.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances listed in schedule 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.
[[Page 51400]]
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 September 19, 2011.
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, 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: August 9, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-21068 Filed 8-17-11; 8:45 am]
BILLING CODE 4410-09-P