Manufacturer of Controlled Substances; Notice of Application, 29719 [E9-14707]
Download as PDF
<![CDATA[
29719
Federal Register / Vol. 74, No. 119 / Tuesday, June 23, 2009 / Notices
Administration (DEA) to be registered as
an importer of Phenylacetone (8501), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
listed controlled substance to bulk
manufacture amphetamine.
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 July 23, 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: June 15, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–14729 Filed 6–22–09; 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 substances, provide manufacturers
holding registrations for the bulk
VerDate Nov<24>2008
16:15 Jun 22, 2009
Jkt 217001
manufacture of the substance an
opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on May 28,
2009, Aptuit (Allendale) Inc., 75
Commerce Drive, Allendale, New Jersey
07401, made application by renewal to
the Drug Enforcement Administration
(DEA) for registration as an importer of
the basic classes of controlled
substances listed in schedule II.
Schedule
Drug
Lisdexamfetamine (1205) ...............
Noroxymorphone (9668) ................
II
II
The company plans to import the
basic classes of controlled substances
for clinical trials and research.
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 July 23, 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 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: June 15, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–14724 Filed 6–22–09; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on May 27, 2009,
Boehringer Ingelheim Chemicals, Inc.,
2820 N. Normandy Drive, Petersburg,
Virginia 23805, made application by
renewal to the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of the basic classes of
controlled substances listed in schedule
II:
Drug
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Schedule
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers for formulation
into finished pharmaceuticals.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
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 August 24, 2009.
Dated: June 15, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–14707 Filed 6–22–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to Section 1301.33(a) of Title
21 of the Code of Federal Regulations
(CFR), this is notice that on May 22,
2009, Noramco Inc., Division of OrthoMcNeil, Inc., 1440 Olympic Drive,
Athens, GA 30601, made application by
letter to the Drug Enforcement
Administration (DEA) for registration as
a bulk manufacturer of Tapentadol
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 74, Number 119 (Tuesday, June 23, 2009)]
[Notices]
[Page 29719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14707]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application
Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal
Regulations (CFR), this is notice that on May 27, 2009, Boehringer
Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia
23805, made application by renewal to the Drug Enforcement
Administration (DEA) as a bulk manufacturer of the basic classes of
controlled substances listed in schedule II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers for formulation into finished
pharmaceuticals.
Any other such applicant, and any person who is presently
registered with DEA to manufacture such substances, may file comments
or objections to the issuance of the proposed registration pursuant to
21 CFR 1301.33(a).
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 August 24, 2009.
Dated: June 15, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-14707 Filed 6-22-09; 8:45 am]
BILLING CODE 4410-09-P
