Manufacturer of Controlled Substances; Notice of Application, 61909 [E8-24767]
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Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
sroberts on PROD1PC70 with NOTICES
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 registration 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, 2008, Formulation
Technologies LLC., 11400 Burnet Road,
Suite 4010, Austin, Texas 78758, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of Fentanyl
(9801), a basic class of controlled
substance listed in schedule II.
The company plans to import the
listed controlled substance for analytical
characterization, secondary packaging,
and/or for distribution to clinical trial
sites.
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
being sent via regular mail 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
17, 2008.
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 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
VerDate Aug<31>2005
19:18 Oct 16, 2008
Jkt 217001
Dated: October 9, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–24783 Filed 10–16–08; 8:45 am]
BILLING CODE 4410–09–P
61909
Dated: October 9, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–24767 Filed 10–16–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 August 5, 2008,
Noramco Inc., Division of Ortho McNeil,
Inc., 500 Swedes Landing Road,
Wilmington, Delaware 19801–4417,
made application by renewal to the
Drug Enforcement Administration
(DEA) as a bulk manufacturer of the
basic classes of controlled substances
listed in schedules I and II:
Drug
Schedule
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Morphine-N-oxide (9307) .............
Methylphenidate (1724) ................
Methylphenidate HCL (1726) .......
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Thebaine (9333) ...........................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture the above listed controlled
substances for sale and distribution to
manufacturers for product development
and formulation.
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 December 16, 2008.
PO 00000
Frm 00133
Fmt 4703
Sfmt 4703
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 July 10, 2008,
Penick Corporation, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
made application by letter to the Drug
Enforcement Administration (DEA) as a
bulk manufacturer of Oripavine (9330),
a basic class of controlled substance
listed in schedule II.
The company will use the above
listed controlled substance in the
manufacture of other controlled
substance intermediates for sale to its
customers.
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 December 16, 2008.
Dated: October 9, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–24768 Filed 10–16–08; 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) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on July 15, 2008,
Cerilliant Corporation, 811 Paloma
Drive, Suite A, Round Rock, Texas
78665–2402, made application by
renewal to the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of the basic classes of
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]]>Agencies
[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Page 61909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24767]
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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 August 5, 2008, Noramco Inc.,
Division of Ortho McNeil, Inc., 500 Swedes Landing Road, Wilmington,
Delaware 19801-4417, made application by renewal to the Drug
Enforcement Administration (DEA) as a bulk manufacturer of the basic
classes of controlled substances listed in schedules I and II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Codeine-N-oxide (9053)..................... I
Dihydromorphine (9145)..................... I
Morphine-N-oxide (9307).................... I
Methylphenidate (1724)..................... II
Methylphenidate HCL (1726)................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Morphine (9300)............................ II
Thebaine (9333)............................ II
Opium extracts (9610)...................... II
Opium fluid extract (9620)................. II
Opium tincture (9630)...................... II
Opium, powdered (9639)..................... II
Opium, granulated (9640)................... II
Oxymorphone (9652)......................... II
------------------------------------------------------------------------
The company plans to bulk manufacture the above listed controlled
substances for sale and distribution to manufacturers for product
development and formulation.
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 December 16, 2008.
Dated: October 9, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E8-24767 Filed 10-16-08; 8:45 am]
BILLING CODE 4410-09-P
