Manufacturer of Controlled Substances; Notice of Registration, 7924-7925 [E9-3648]
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Federal Register / Vol. 74, No. 33 / Friday, February 20, 2009 / Notices
an importer of the basic classes of
controlled substances listed in schedule
II:
Drug
Schedule
Oxycodone (9143) .........................
Morphine (9300) ............................
II
II
Drug
The company plans to import
controlled substances for clinical trials
and analytical testing.
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 March 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 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.
Dated: February 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–3650 Filed 2–19–09; 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 January 8, 2009,
Sigma Aldrich Research Biochemicals,
Inc., 1–3 Strathmore Road, Natick,
VerDate Nov<24>2008
17:55 Feb 19, 2009
Jkt 217001
Massachusetts 01760–2447, 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:
Schedule
Cathinone (1235) ..........................
Methcathinone (1237) ...................
Aminorex (1585) ............................
Gamma
Hydroxybutyric
Acid
(2010).
Alpha-ethyltryptamine (7249) ........
Lysergic acid diethylamide (7315)
Tetrahydrocannabinols (7370) ......
4–Bromo-2,5dimethoxyamphetamine (7391).
4–Bromo-2,5dimethoxyphenethylamine
(7392).
2,5–Dimethoxyamphetamine
(7396).
3,4–Methylenedioxyamphetamine
(7400).
N-Hydroxy-3,4methylenedioxyamphetamine
(7402).
3,4–Methylenedioxy-Nethylamphetamine (7404).
3,4–
Methylenedioxymethamphetamine (MDMA) (7405).
Psilocybin (7437) ...........................
5–Methoxy-N,Ndiisopropyltryptamine (7439).
1-[1-(2–
Thienyl)cyclohexyl]piperidine
(TCP) (7470).
1–Benzylpiperazine (BZP) (7493)
Heroin (9200) ................................
Normorphine (9313) ......................
Amphetamine (1100) .....................
Methamphetamine (1105) .............
Nabilone (7379) .............................
1–Phenylcyclohexylamine (7460)
Phencyclidine (7471) .....................
Cocaine (9041) ..............................
Codeine (9050) .............................
Diprenorphine (9058) ....................
Ecgonine (9180) ............................
Levomethorphan (9210) ................
Levorphanol (9220) .......................
Meperidine (9230) .........................
Metazocine (9240) ........................
Methadone (9250) .........................
Morphine (9300) ............................
Thebaine (9333) ............................
Levo-alphacetylmethadol (9648) ...
Carfentanil (9743) .........................
Fentanyl (9801) .............................
I
I
I
I
I
I
I
I
Frm 00075
Fmt 4703
Sfmt 4703
Dated: February 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–3646 Filed 2–19–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
I
Manufacturer of Controlled
Substances; Notice of Registration
I
By Notice dated October 28, 2008 and
published in the Federal Register on
November 3, 2008, (73 FR 65404),
Cedarburg Pharmaceuticals, Inc., 870
Badger Circle, Grafton, Wisconsin
53024, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the basic classes of
controlled substances listed in
schedules I and II:
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
reference standards.
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
PO 00000
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than April 21, 2009.
Drug
Tetrahydrocannabinols (7370) ......
Dihydromorphine (9145) ...............
Dihydrocodeine (9120) ..................
Oxycodone (9143) .........................
Hydromorphone (9150) .................
Hydrocodone (9193) .....................
Remifentanil (9739) .......................
Sufentanil (9740) ...........................
Fentanyl (9801) .............................
Schedule
I
I
II
II
II
II
II
II
II
The company plans to manufacture
the listed 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
determined that the registration of
Cedarburg Pharmaceuticals, Inc. to
manufacture the listed basic classes of
controlled substances is consistent with
the public interest at this time. DEA has
investigated Cedarburg Pharmaceuticals,
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
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Federal Register / Vol. 74, No. 33 / Friday, February 20, 2009 / Notices
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.
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: February 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–3648 Filed 2–19–09; 8:45 am]
Dated: February 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–3649 Filed 2–19–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances; Notice of Registration
DEPARTMENT OF LABOR
By Notice dated October 9, 2008 and
published in the Federal Register on
October 17, 2008, (73 FR 61911),
Noramco Inc., 1440 Olympic Drive,
Athens, Georgia 30601, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances listed in schedules I and II:
Drug
Schedule
Codeine-N-oxide (9053) ................
Morphine-N-oxide (9307) ..............
Amphetamine (1100) .....................
Methylphenidate (1724) ................
Codeine (9050) .............................
Dihydrocodeine (9120) ..................
Oxycodone (9143) .........................
Hydromorphone (9150) .................
Hydrocodone (9193) .....................
Morphine (9300) ............................
Oripavine (9330) ...........................
Thebaine (9333) ............................
Oxymorphone (9652) ....................
Alfentanil (9737) ............................
Sufentanil (9740) ...........................
Carfentanil (9743) .........................
Fentanyl (9801) .............................
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
small quantities of the schedule I
controlled substances for internal
testing; the schedule II controlled
substances will be manufactured 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
determined that the registration of
Noramco Inc. to manufacture the listed
basic classes of controlled substances is
consistent with the public interest at
this time. DEA has investigated
Noramco 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
VerDate Nov<24>2008
17:55 Feb 19, 2009
Jkt 217001
Office of the Secretary
Submission for OMB Review:
Comment Request
February 13, 2009.
The Department of Labor (DOL)
hereby announces the submission of the
following public information collection
request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. chapter 35).
A copy of this ICR, with applicable
supporting documentation; including
among other things a description of the
likely respondents, proposed frequency
of response, and estimated total burden
may be obtained from the RegInfo.gov
Web site at https://www.reginfo.gov/
public/do/PRAMain or by contacting
Mary Beth Smith-Toomey on 202–693–
4223 (this is not a toll-free number) / email: DOL_PRA_PUBLIC@dol.gov.
Interested parties are encouraged to
send comments to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for the
Department of Labor—ETA, Office of
Management and Budget, Room 10235,
Washington, DC 20503, Telephone:
202–395–7316/Fax: 202–395–6974
(these are not toll-free numbers), E-mail:
OIRA_submission@omb.eop.gov within
30 days from the date of this publication
in the Federal Register. In order to
ensure the appropriate consideration,
comments should reference the OMB
Control Number (see below).
The OMB is particularly interested in
comments which:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
PO 00000
Frm 00076
Fmt 4703
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7925
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Agency: Employment Training
Administration.
Type of Review: Extension without
change of currently approved collection.
Title of Collection: Labor Exchange
Reporting System (LERS).
OMB Control Number: 1205–0240.
Agency Form Numbers: ETA 200–
VETS, VETS 200A, VETS 200B, VETS
200C, ETA 9002A, ETA 9002B, ETA
9002C, ETA 9002D, and ETA 9002E.
Affected Public: State, Local and
Tribal Governments.
Total Estimated Number of
Respondents: 54.
Total Estimated Annual Burden
Hours: 527,023.
Total Estimated Annual Costs Burden:
$ 0.
Description: States submit quarterly
performance data for the Wagner-Peyser
funded public labor exchange services
through ETA 9002 reports and for
Veterans’ Employment and Training
Services (VETS)-funded labor exchange
services through VETS 200 reports. The
Employment and Training (ET)
Handbook No. 406 contains the report
forms and provides instructions for
completing these reports. The ETA
Handbook No. 406 contains a total of
eight reports (ETA 9002, A, B, C, D, E;
VETS 200 A, B, C). The ETA 9002 and
VETS 200 reports collect data on
individuals who receive core
employment and workforce information
services through the public labor
exchange and VETS-funded labor
exchange of the states’ One-Stop
delivery systems. Respondents are State
governments. Selected standardized
information pertaining to customers in
Wagner-Peyser programs are collected
and reported for the purposes of general
program oversight, evaluation and
performance assessment. For additional
information, see related notice
published at Volume 73 FR 45075 on
August 1, 2008.
Darrin A. King,
Departmental Clearance Officer.
[FR Doc. E9–3626 Filed 2–19–09; 8:45 am]
BILLING CODE 4510–FN–P
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]]>Agencies
[Federal Register Volume 74, Number 33 (Friday, February 20, 2009)]
[Notices]
[Pages 7924-7925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3648]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated October 28, 2008 and published in the Federal
Register on November 3, 2008, (73 FR 65404), Cedarburg Pharmaceuticals,
Inc., 870 Badger Circle, Grafton, Wisconsin 53024, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered
as a bulk manufacturer of the basic classes of controlled substances
listed in schedules I and II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)................ I
Dihydromorphine (9145)...................... I
Dihydrocodeine (9120)....................... II
Oxycodone (9143)............................ II
Hydromorphone (9150)........................ II
Hydrocodone (9193).......................... II
Remifentanil (9739)......................... II
Sufentanil (9740)........................... II
Fentanyl (9801)............................. II
------------------------------------------------------------------------
The company plans to manufacture the listed 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 determined that the registration of
Cedarburg Pharmaceuticals, Inc. to manufacture the listed basic classes
of controlled substances is consistent with the public interest at this
time. DEA has investigated Cedarburg Pharmaceuticals, 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
[[Page 7925]]
registration as a bulk manufacturer of the basic classes of controlled
substances listed.
Dated: February 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-3648 Filed 2-19-09; 8:45 am]
BILLING CODE 4410-09-P
