Manufacturer of Controlled Substances; Notice of Application, 390 [05-76]
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Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Notices
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 September
22, 2004 and October 29, 2004,
Cedarburg Pharmaceuticals, Inc., 870
Badger Circle, Grafton, Wisconsin
53024, made application by letter to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the basic classes of
controlled substances listed in Schedule
II.
Drug
Schedule
Dihydrocodeine (9120) .................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution 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.
Any such comments or objections
may be addressed, in quintuplicate, to
the Deputy Assistant Administrator,
Office of Diversion Control, Drug
Enforcement Administration, United
States Department of Justice,
Washington, DC 20537, Attention:
Federal Register Representative, Office
of Liaison and Policy (ODLR) and must
be filed no later than March 7, 2005.
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 05–76 Filed 1–3–05; 8:45 am]
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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)(B) authorizing the importation
of such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
VerDate jul<14>2003
18:02 Jan 03, 2005
Jkt 205001
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on July 7,
2004, Chattem Chemicals Inc., 3801 St
Elmo Avenue, Building 18, Chattanooga,
Tennessee 37409, made application by
renewal to the Drug Enforcement
Administration (DEA) for registration as
an importer of the basic classes of
controlled substances listed below:
Schedule
Drug
N-Ethylamphetamine (1475) ..........
2,5-Dimethoxyamphetamine (7396)
4-Methoxyamphetamine (7411) .....
Difenoxin (9168) .............................
Methamphetamine (1105) ..............
Raw Opium (9600) .........................
Concentrate of Poppy Straw
(9670).
I
I
I
I
II
II
II
The company plans to import small
quantities of the listed controlled
substances for the manufacture of
analytical reference standards.
Any 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 or
requests for hearing may be addressed,
in quintuplicate, to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, United States
Department of Justice, Washington, DC
20537, Attention: DEA Federal Register
Representative, Office of Liaison and
Policy (ODLR) and must be filed no later
than February 3, 2005.
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 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.
PO 00000
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration,
[FR Doc. 05–75 Filed 1–3–05; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated July 21, 2004, and
published in the Federal Register on
August 10, 2004, (69 FR 48522), Dade
Behring Inc., Route 896 Corporate
Boulevard, Building 100, Attention: RA/
QA, Post Office Box 6101, Newark,
Delaware 19714, made application by
renewal to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of the basic classes
of controlled substances:
Drug
Tetrahydrocannabionols (7370) .....
Ecgonine (9180) .............................
Morphine (9300) .............................
Fmt 4703
Sfmt 4703
I
II
II
The company plans to produce the
listed controlled substances in bulk to
be used in the manufacture of reagents
and drug calibrator/controls for DEA
exempt products.
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 Dade
Behring Inc. to manufacture the listed
basic classes of controlled substances is
consistent with the public interest at
this time. DEA has investigated Dade
Behring 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 classes of controlled
substances listed.
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 05–65 Filed 1–3–05; 8:45 am]
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[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Notices]
[Page 390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-76]
[[Page 390]]
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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 September 22, 2004 and
October 29, 2004, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle,
Grafton, Wisconsin 53024, made application by letter to the Drug
Enforcement Administration (DEA) to be registered as a bulk
manufacturer of the basic classes of controlled substances listed in
Schedule II.
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Dihydrocodeine (9120)...................... II
Remifentanil (9739)........................ II
Sufentanil (9740).......................... II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution 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.
Any such comments or objections may be addressed, in quintuplicate,
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, United States Department of Justice,
Washington, DC 20537, Attention: Federal Register Representative,
Office of Liaison and Policy (ODLR) and must be filed no later than
March 7, 2005.
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 05-76 Filed 1-3-05; 8:45 am]
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