Importer of Controlled Substances; Notice of Registration, 393-394 [05-59]
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Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Notices
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. 05–70 Filed 1–3–05; 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 November
16, 2004, Organichem Corporation, 33
Riverside Avenue, Rensselaer, New
York 12144, made application by letter
to the Drug Enforcement Administration
(DEA) for registration as a bulk
manufacturer of Hydrocodone (9193)
and Fentanyl (9180), a basic class of
controlled substances in Schedule 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 a substance
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
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. 05–69 Filed 1–3–05; 8:45 am]
Enforcement Administration (DEA) for
registration as a bulk manufacturer of
Codeine (9041), a basic class of
controlled substance listed in Schedule
II.
The company plans to manufacture
small quantities of the listed controlled
substance for use in drug abuse
detection kits.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such a substance
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
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: DEA
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. 05–67 Filed 1–3–05; 8:45 am]
Pursuant to 21 CFR 1301.33(a), Title
21 of the Code of Federal Regulations
(CFR), this is notice that on September
2, 2004, Organix Inc., 240 Salem Street,
Woburn, Massachusetts 01801, made
application by renewal to the Drug
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18:02 Jan 03, 2005
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BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Importer of Controlled Substances;
Notice of Registration
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 48525), Syva
Company, Dade Behring Inc., Regulatory
Affairs Dept. 1–310, 20400 Mariani
Avenue, Cupertino, California 95014,
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 below, and
by letter dated July 6, 2004, to modify
its name to Dade Behring, Inc.
Schedule
Tetrahydrocannabionols (7370) ...
Ecgonine (9180) ...........................
Morphine (9300) ...........................
Manufacturer of Controlled
Substances; Notice of Application
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 05–62 Filed 1–3–05; 8:45 am]
Drug Enforcement Administration
Drug
Drug Enforcement Administration
Company, Dade Behring Inc. to
manufacture the listed basic classes of
controlled substances is consistent with
the public interest at this time. DEA has
investigated Syva Company, 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.
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
393
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 Syva
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Fmt 4703
Sfmt 4703
By Notice dated September 16, 2004
and published in the Federal Register
on September 30, 2004, (69 FR 58548),
Tocris Cookson, Inc., 16144 Westwoods
Business Park, Ellisville, Missouri
63021–4500, made application by
renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Tetrahydrocannabinols
(7370), a basic class of controlled
substance listed in Schedule I.
The company plans to import small
quantities of the listed substance for
research purposes.
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
Tocris Cookson, 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 Tocris
Cookson, 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
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04JAN1
394
Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Notices
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 class of controlled substance
listed.
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 05–59 Filed 1–3–05; 8:45 am]
BILLING CODE 4410–09–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 50–312]
Sacramento Municipal Utility District;
Rancho Seco Nuclear Generating
Station; Partial Exemption from
Requirements of 10 CFR 50.719(c); 10
CFR Part 50, Appendix A; 10 CFR Part
50, Appendix B
1.0
Background
Sacramento Municipal Utility District
(SMUD) is the licensee and holder of
Facility Operating License No. DPR–54
for the Rancho Seco Nuclear Generating
Station (Rancho Seco), a permanently
shutdown decommissioning nuclear
plant. Although permanently shutdown,
this facility is still subject to all rules,
regulations, and orders of the U.S.
Nuclear Regulatory Commission (NRC).
The Sacramento Municipal Utility
District (SMUD) shut down Rancho
Seco Nuclear Generating Station
permanently on June 7, 1989, after
approximately 15 years of operation. On
August 29, 1989, SMUD formally
informed the NRC that the plant was
shut down permanently. On May 20,
1991, SMUD submitted the Rancho Seco
decommissioning plan and on March
20, 1995, the NRC issued an Order
approving the decommissioning plan
and authorizing the decommissioning of
Rancho Seco.
SMUD began actively
decommissioning Rancho Seco in
February 1997, and completed the
transfer of all of the spent nuclear fuel
to the 10 CFR Part 72 licensed
Independent Spent Fuel Storage
Installation (ISFSI) on August 21, 2002.
Accordingly, the only quality-related
structures, systems, or components
(SSCs) at the Rancho Seco 10 CFR Part
50 licensed site are the radioactive
sources used to calibrate the
instrumentation used to measure
radioactivity in gaseous and liquid
effluents.
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Plant dismantlement is substantially
(approximately 80%) complete and
most of the SSCs that were safetyrelated or important-to-safety have been
removed from the plant and shipped for
disposal. The pressurizer was shipped
to Envirocare for disposal in April 2004,
removal of the steam generators is in
progress with both steam generators
scheduled to be shipped to Envirocare
by spring 2005 (one by the end of 2004
and the second in spring 2005), and
activities in preparation for the reactor
vessel internals segmentation are
underway and mobilization of the
segmentation contractor is scheduled to
begin in early 2005.
On September 2, 2004, SMUD filed a
request for NRC approval of a partial
exemption from the recordkeeping
requirements of 10 CFR 50.71(c); 10 CFR
50, Appendix A; and 10 CFR 50,
Appendix B.
2.0 Request/Action
Pursuant to the requirements of 10
CFR 50.71(d)(2) and 10 CFR 50.12,
SMUD requested partial exemption to
the recordkeeping requirements of 10
CFR 50.71(c); 10 CFR Part 50, Appendix
A; CFR Part 50, Appendix B. This
exemption request was characterized as
‘‘partial’’ because the exemption would
apply only to the disposal of hardcopies
of records, prior to termination of the
Rancho Seco license, that: (1) Are
associated with the operation, design,
fabrication, erection, and testing of
structures, systems, and components
(SSCs) that are no longer quality-related
or important to safety or have been
removed from the plant for disposal;
and (2) require storage in their original
hard copy format due to practical and
feasibility limitations associated with
transferring them to microfilm or
microfiche.
Most of these records are for SSCs that
have been removed from Rancho Seco
and disposed of off-site. Disposal of
these records will not adversely impact
the ability to meet other NRC regulatory
requirements for the retention of records
[e.g., 10 CFR 50.54(a), (p), (q), and (bb);
10 CFR 50.59(d); 10 CFR 50.75(g); etc.].
These regulatory requirements ensure
that records from operation and
decommissioning activities are
maintained for safe decommissioning,
spent nuclear fuel storage, completion
and verification of final site survey, and
license termination.
3.0 Discussion
NRC licensees are required to
maintain their records according to the
NRC regulatory recordkeeping
requirements. Pursuant to the
requirements of 10 CFR 50.12, ‘‘Specific
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Frm 00069
Fmt 4703
Sfmt 4703
Exemptions,’’ and 10 CFR 50.71(d)(2),
SMUD filed a request for a partial
exemption from the NRC regulatory
recordkeeping requirements contained
in 10 CFR 50.71(c), 10 CFR 50,
Appendix A, and 10 CFR 50, Appendix
B. The NRC recordkeeping requirements
at issue in SMUD’s request for
exemption are as follows.
10 CFR 50.71, ‘‘Maintenance of records,
making of reports,’’ subpart (c) states:
Records that are required by the regulations
in this part, by license condition, or by
technical specifications, must be retained for
the period specified by the appropriate
regulation, license condition, or technical
specification. If a retention period is not
otherwise specified, these records must be
retained until the Commission terminates the
facility license.
10 CFR 50, Appendix A, ‘‘General
Design Criteria for Nuclear Power
Plants,’’ establishes the necessary
design, fabrication, construction,
testing, and performance requirements
for structures, systems, and components
important to safety; that is, structures,
systems, and components that provide
reasonable assurance that the facility
can be operated without undue risk to
the health and safety of the public.
Specifically, SMUD requests an
exemption from Criterion 1, ‘‘Quality
standards and records,’’ which states in
part:
Appropriate records of the design,
fabrication, erection, and testing of
structures, systems, and components
important to safety shall be maintained by or
under the control of the nuclear power unit
licensee throughout the life of the unit.’’
10 CFR 50, Appendix B, ‘‘Quality
Assurance Criteria for Nuclear Power
Plants and Fuel Reprocessing Plants,’’
establishes quality assurance
requirements for the design,
construction, and operation of
structures, systems, and components
that prevent or mitigate the
consequences of postulated accidents
that could cause undue risk to the
health and safety of the public.
Specifically, SMUD requests an
exemption from Criterion XVII, ‘‘Quality
Assurance Records,’’ which states:
Sufficient records shall be maintained to
furnish evidence of activities affecting
quality. The records shall include at least the
following: Operating logs and the results of
reviews, inspections, tests, audits,
monitoring of work performance, and
materials analyses. The records shall also
include closely-related data such as
qualifications of personnel, procedures, and
equipment. Inspection and test records shall,
as a minimum, identify the inspector or data
recorder, the type of observation, the results,
the acceptability, and the action taken in
connection with any deficiencies noted.
Records shall be identifiable and retrievable.
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Agencies
[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Notices]
[Pages 393-394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-59]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated September 16, 2004 and published in the Federal
Register on September 30, 2004, (69 FR 58548), Tocris Cookson, Inc.,
16144 Westwoods Business Park, Ellisville, Missouri 63021-4500, made
application by renewal to the Drug Enforcement Administration (DEA) to
be registered as an importer of Tetrahydrocannabinols (7370), a basic
class of controlled substance listed in Schedule I.
The company plans to import small quantities of the listed
substance for research purposes.
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 Tocris Cookson, 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
Tocris Cookson, 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
[[Page 394]]
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 class
of controlled substance listed.
Dated: December 21, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 05-59 Filed 1-3-05; 8:45 am]
BILLING CODE 4410-09-P