Importer of Controlled Substances; Notice of Application, 19595 [E9-9780]
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Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices
Dated: April 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–9782 Filed 4–28–09; 8:45 am]
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 the 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.
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
§ 1301.34(a), this is notice that on March
10, 2009, Almac Clinical Services Inc.
(ACSI), 2661 Audubon Road, Audubon,
Pennsylvania 19403, has made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
pwalker on PROD1PC71 with NOTICES
Oxycodone (9143) ........................
Fentanyl (9801) ............................
17:48 Apr 28, 2009
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Jkt 217001
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: April 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–9789 Filed 4–28–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated January 30, 2009, and
published in the Federal Register on
February 6, 2009 (74 FR 6309),
Mallinckrodt Inc., 3600 North Second
Street, St. Louis, Missouri 63147, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
Schedule
classes of controlled substances listed in
II schedule II:
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances 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 May 29, 2009.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
VerDate Nov<24>2008
Dated: April 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–9780 Filed 4–28–09; 8:45 am]
19595
Drug
Schedule
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw (9650) .....................
Poppy Straw Concentrate (9670)
II
II
II
II
II
The company plans to import the
listed controlled substances for the
manufacture of controlled substances 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 952(a)
and determined that the registration of
Mallinckrodt 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
Mallinckrodt 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
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
By Notice dated December 22, 2008,
and published in the Federal Register on
December 31, 2008 (73 FR 80431), Norac
Inc., 405 S. Motor Avenue, P.O. Box
577, Azusa, California 91702–3232,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of Tetrahydrocannabinols
(7370), a basic class of controlled
substance listed in schedule I.
The company plans to manufacture
the listed controlled substance in bulk
for formulation into the pharmaceutical
controlled substance Marinol® for sale
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
Norac Inc. to manufacture the listed
basic class of controlled substance is
consistent with the public interest at
this time. DEA has investigated Norac
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. 823,
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic class of controlled substance
listed.
E:\FR\FM\29APN1.SGM
29APN1
]]>Agencies
[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Page 19595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9780]
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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
Sec. 1301.34(a), this is notice that on March 10, 2009, Almac Clinical
Services Inc. (ACSI), 2661 Audubon Road, Audubon, Pennsylvania 19403,
has made application by renewal 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
------------------------------------------------------------------------
Oxycodone (9143)............................................. II
Fentanyl (9801).............................................. II
------------------------------------------------------------------------
The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances 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 May 29, 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 the 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: April 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-9780 Filed 4-28-09; 8:45 am]
BILLING CODE 4410-09-P
