Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments, 76056-76058 [E5-7644]
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76056
Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices
Based on the history of the PHN
program, it is estimated that an average
of three collections will be conducted a
year. The total burden of response time
is estimated at 10 minutes per survey.
This was derived by CDRH staff
completing the survey and through
discussions with the contacts in trade
organizations.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7642 Filed 12–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0274]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary Hazard
Analysis and Critical Control Point
Manuals for Operators and Regulators
of Retail and Food Service
Establishments
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 23,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
VerDate Aug<31>2005
17:05 Dec 21, 2005
Jkt 208001
has submitted the following proposed
collection of information to OMB for
review and clearance.
Voluntary Hazard Analysis and Critical
Control Point (HACCP) Manuals for
Operators and Regulators of Retail and
Food Service Establishments
The draft Operator’s Manual contains
information and recommendations for
operators of retail and foodservice
establishments who wish to develop
and implement a voluntary food safety
management system based on HACCP
principles. Operators may decide to
incorporate some or all of the principles
presented in the draft manual into their
existing food safety management
systems. The recordkeeping practices
discussed in the draft manual are
voluntary and may include
documenting certain activities, such as
monitoring and verification, which the
operator may or may not deem
necessary to ensure food safety. The
draft manual includes optional
worksheets to assist operators in
developing and validating a voluntary
food safety management system.
The draft Regulator’s Manual contains
recommendations for State, local, and
tribal regulators on conducting riskbased inspections of retail and
foodservice establishments, including
recommendations about recordkeeping
practices that can assist operators in
preventing foodborne illness. These
recommendations may lead to voluntary
actions by operators based on
consultation with regulators. For
example, an operator may develop a risk
control plan as an intervention strategy
for controlling specific out-of-control
foodborne illness risk factors identified
during an inspection. Further, the draft
manual contains recommendations to
assist regulators when evaluating
voluntary food safety management
systems in retail and foodservice
establishments. Such evaluations
typically consist of the following two
components: Validation (assessing
whether the establishment’s voluntary
food safety management system is
adequate to control food safety hazards)
and verification (assessing whether the
establishment is following its voluntary
food safety management system). The
draft manual includes a sample
‘‘Verification Inspection Checklist’’ to
assist regulators when conducting
verification inspections of
establishments with voluntary food
safety management systems.
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Frm 00038
Fmt 4703
Sfmt 4703
Types of operator records discussed
in the manuals and listed in the
following burden estimates include:
Food safety management systems (plans
that delineate the formal procedures to
follow to control all food safety hazards
in an operation); risk control plans
(HACCP-based, goal-oriented plans for
achieving active managerial control over
specific out-of-control foodborne illness
risk factors); hazard analysis (written
assessment of the significant food safety
hazards associated with foods prepared
in the establishment); prerequisite
programs (written policies or
procedures, including but not limited
to, standard operating procedures,
training protocols, and buyer
specifications that address maintenance
of basic operational and sanitation
conditions); monitoring (records
showing the observations or
measurements that are made to help
determine if critical limits are being met
and maintained); corrective action
(records indicating the activities that are
completed whenever a critical limit is
not met); ongoing verification (records
showing the procedures that are
followed to ensure that monitoring and
other functions of the food safety
management system are being
implemented properly); and validation
(records indicating that scientific and
technical information is collected and
evaluated to determine if the food safety
management system, when properly
implemented, effectively controls the
hazards).
All recommendations in both manuals
are voluntary. For simplicity and to
avoid duplicate estimates for operator
recordkeeping practices that are
discussed in both manuals, the burden
for all collection of information
recommendations for retail and
foodservice operators are estimated
together in table 1 of this document,
regardless of the manual in which they
appear. Collection of information
recommendations for regulators in the
Regulator’s Manual are listed separately
in table 2 of this document.
The likely respondents to this
collection of information are operators
and regulators of retail and foodservice
establishments.
In the Federal Register of July 21,
2005 (70 FR 42072), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of the
collection of information as follows:
E:\FR\FM\22DEN1.SGM
22DEN1
Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices
76057
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR OPERATORS1
No. of
Recordkeepers
Types of Records
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
Food Safety Management System
50,0002
1
50,000
60
3,000,000
Hazard Analysis
50,0002
1
50,000
20
1,000,000
Prerequisite Program Records
100,0003
365
36,500,000
0.1
3,650,000
Monitoring Records
100,0003
365
36,500,000
0.3
10,950,000
Corrective Action Records
100,0003
365
36,500,000
0.1
3,650,000
Ongoing Verification Records (includes
calibration records)
100,0003
365
36,500,000
0.1
3,650,000
50,0003
1
50,000
Validation Records
4
200,000
Total First Year Burden4:
26,100,000
Annual Burden4:
22,100,000
Risk Control Plan
50,000
1
50,000
2
Monitoring Records
100,000
90
9,000,000
0.3
2,700,000
Corrective Action Records
100,000
90
9,000,000
0.1
900,000
Ongoing Verification Records (includes
calibration records)
100,000
90
9,000,000
0.1
900,000
Annual Burden5
100,000
4,600,000
Total Annual Burden for Operators (Excluding First Year)
26,700,000
1 There
cchase on PROD1PC60 with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 First year burden only.
3 Annual burden.
4 Burden for developing and implementing a food safety management system based on the Operator’s Manual.
5 Annual burden for developing and implementing a risk control plan based on the Regulator’s Manual.
The burden for these activities may
vary among retail and foodservice
operators depending on the type and
number of products involved, the
complexity of an establishment’s
operation, the nature of the equipment
or instruments required to monitor
critical control points, and the extent to
which an operator uses the Operator’s
Manual and/or the Regulator’s Manual.
The estimate does not include
collections of information that are a
usual and customary part of an
operator’s normal activities. FDA has
established as a goal to have 50,000 (1/
2 of 1 percent) of the approximately one
million U.S. retail and foodservice
operators implement the
recommendations outlined in the two
manuals. This target figure is used in
calculating the burden in tables 1 and 2
of this document because the agency
lacks data on how to base an estimate
of how many retail and foodservice
establishments are likely to use one or
more of the manuals to voluntarily
implement a comprehensive food safety
management system based on HACCP
principles or a risk control plan for outof-control processes identified during an
VerDate Aug<31>2005
16:55 Dec 21, 2005
Jkt 208001
inspection. FDA’s estimate of the total
number of retail and foodservice
establishments is based on numbers
obtained from the two major trade
organizations representing these
industries, the Food Marketing Institute
and the National Restaurant
Association, respectively. FDA seeks
comments on this estimate.
The hour burden estimates in table 1
of this document for operators who
follow the HACCP-based
recommendations in the Operator’s
Manual are based on the estimated
average annual information collection
burden for mandatory HACCP rules,
including seafood HACCP (60 FR 65096
at 65178, December 18, 1995) and juice
HACCP (66 FR 6138 at 6202, January 19,
2001). FDA estimates that during the
first year, 20 labor hours are needed to
conduct the hazard analysis and 60
labor hours are needed to develop a
food safety management system (HACCP
plan). Once the system is in place, the
annual frequency of records is based on
365 operating days per year. Assuming
there is one recordkeeper per shift of
operation, the agency estimates that two
recordkeepers per day would be needed
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
to conduct monitoring, corrective
action, recordkeeping, and verification
outlined in the system. The agency
further estimates that validation will be
conducted once per year, based on
menu or food list changes, changes in
distributors, or changes in food
preparation processes used. The
validation will require a total of 4 labor
hours.
The second set of estimates in table 1
of this document shows the annual
burden for developing and
implementing a risk control plan to
control specific out-of-control foodborne
illness risk factors identified during an
inspection by a State, local, or tribal
regulatory authority. If an operator
decides to use a risk control plan as
recommended in the Regulator’s
Manual, one person from the
establishment is needed to work with
the regulator to develop the written
plan. FDA estimates that two
recordkeepers per day (one
recordkeeper for each shift) would be
needed to conduct monitoring,
corrective action, recordkeeping, and
verification outlined in the risk control
plan. The estimated duration of
E:\FR\FM\22DEN1.SGM
22DEN1
76058
Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices
implementation for a risk control plan is
90 days, which is the minimum
recommended time to achieve long-term
behavior change.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR REGULATORS1
No. of
Recordkeepers
Types of Records
Voluntary Food Safety Management System Evaluation (includes validation, verification, and completion
of verification inspection checklist)
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
1
50,000
16
800,000
50,000
Total Annual Burden for Regulators
1 There
800,000
are no capital costs or operating and maintenance costs associated with this collection of information.
It is difficult to predict the number of
State, local, and tribal regulatory
jurisdictions that will use the
Regulator’s Manual. But FDA
anticipates that retail and foodservice
establishments which voluntarily
develop and implement a food safety
management system based on the
Operator’s Manual will request their
regulatory authorities to conduct an
evaluation of their system. The
estimates in table 2 of this document for
the annual burden to State, local, and
tribal regulators that follow the
recommendations in the Regulator’s
Manual were calculated based on the
usual time needed for one person to
evaluate a voluntarily-implemented
food safety management system and
record the findings. The number of
times an inspector may be asked by an
operator to evaluate a voluntarilyimplemented system is not expected to
exceed once per year.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7644 Filed 12–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committees; Tentative
Schedule of Meetings for 2006
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
tentative schedule of forthcoming
meetings of its public advisory
committees for 2006. During 1991, at the
request of the Commissioner of Food
and Drugs (the Commissioner), the
Institute of Medicine (the IOM)
conducted a study of the use of FDA’s
advisory committees. In its final report,
one of the IOM’s recommendations was
for the agency to publish an annual
tentative schedule of its meetings in the
Federal Register. This publication
implements the IOM’s recommendation.
FOR FURTHER INFORMATION CONTACT:
Theresa L. Green, Advisory Committee
Oversight and Management Staff (HF–
4), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–1220.
SUPPLEMENTARY INFORMATION: The IOM,
at the request of the Commissioner,
Committee Name
undertook a study of the use of the
FDA’s advisory committees. In its final
report in 1992, one of the IOM’s
recommendations was for FDA to adopt
a policy of publishing an advance yearly
schedule of its upcoming public
advisory committee meetings in the
Federal Register; FDA has implemented
this recommendation. The annual
publication of tentatively scheduled
advisory committee meetings will
provide both advisory committee
members and the public with the
opportunity, in advance, to schedule
attendance at FDA’s upcoming advisory
committee meetings. Because the
schedule is tentative, amendments to
this notice will not be published in the
Federal Register. However, changes to
the schedule will be posted on the FDA
advisory committees’ Internet site
located at https://www.fda.gov/oc/
advisory/default.htm. FDA will
continue to publish a Federal Register
notice 15 days in advance of each
upcoming advisory committee meeting,
to announce the meeting (21 CFR 14.20).
The following list announces FDA’s
tentatively schedule advisory committee
meeting for 2006. You may also obtain
up-to-date information by calling the
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area).
Tentative Date(s) of Meetings
Advisory Committee
10-Digit Information
Line Code
OFFICE OF THE COMMISSIONER
Pediatric Advisory Committee
March, June, and November day(s) to be announced.
8732310001
Science Board to the Food and Drug Administration
April and November day(s) to be announced.
3014512603
Allergenic Products Advisory Committee
March 31, September 13.
3014512388
Blood Products Advisory Committee
March 9–10, July 13–14, October 26–27.
3014519516
Cellular, Tissue and Gene Therapies Advisory Committee
February 9–10, July 13–14, November 2–3.
3014512389
Transmissible Spongiform Encephalopathies Advisory Committee
To be announced.
3014512392
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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VerDate Aug<31>2005
18:18 Dec 21, 2005
Jkt 208001
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E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[Federal Register Volume 70, Number 245 (Thursday, December 22, 2005)]
[Notices]
[Pages 76056-76058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7644]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0274]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Hazard
Analysis and Critical Control Point Manuals for Operators and
Regulators of Retail and Food Service Establishments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
January 23, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Voluntary Hazard Analysis and Critical Control Point (HACCP) Manuals
for Operators and Regulators of Retail and Food Service Establishments
The draft Operator's Manual contains information and
recommendations for operators of retail and foodservice establishments
who wish to develop and implement a voluntary food safety management
system based on HACCP principles. Operators may decide to incorporate
some or all of the principles presented in the draft manual into their
existing food safety management systems. The recordkeeping practices
discussed in the draft manual are voluntary and may include documenting
certain activities, such as monitoring and verification, which the
operator may or may not deem necessary to ensure food safety. The draft
manual includes optional worksheets to assist operators in developing
and validating a voluntary food safety management system.
The draft Regulator's Manual contains recommendations for State,
local, and tribal regulators on conducting risk-based inspections of
retail and foodservice establishments, including recommendations about
recordkeeping practices that can assist operators in preventing
foodborne illness. These recommendations may lead to voluntary actions
by operators based on consultation with regulators. For example, an
operator may develop a risk control plan as an intervention strategy
for controlling specific out-of-control foodborne illness risk factors
identified during an inspection. Further, the draft manual contains
recommendations to assist regulators when evaluating voluntary food
safety management systems in retail and foodservice establishments.
Such evaluations typically consist of the following two components:
Validation (assessing whether the establishment's voluntary food safety
management system is adequate to control food safety hazards) and
verification (assessing whether the establishment is following its
voluntary food safety management system). The draft manual includes a
sample ``Verification Inspection Checklist'' to assist regulators when
conducting verification inspections of establishments with voluntary
food safety management systems.
Types of operator records discussed in the manuals and listed in
the following burden estimates include: Food safety management systems
(plans that delineate the formal procedures to follow to control all
food safety hazards in an operation); risk control plans (HACCP-based,
goal-oriented plans for achieving active managerial control over
specific out-of-control foodborne illness risk factors); hazard
analysis (written assessment of the significant food safety hazards
associated with foods prepared in the establishment); prerequisite
programs (written policies or procedures, including but not limited to,
standard operating procedures, training protocols, and buyer
specifications that address maintenance of basic operational and
sanitation conditions); monitoring (records showing the observations or
measurements that are made to help determine if critical limits are
being met and maintained); corrective action (records indicating the
activities that are completed whenever a critical limit is not met);
ongoing verification (records showing the procedures that are followed
to ensure that monitoring and other functions of the food safety
management system are being implemented properly); and validation
(records indicating that scientific and technical information is
collected and evaluated to determine if the food safety management
system, when properly implemented, effectively controls the hazards).
All recommendations in both manuals are voluntary. For simplicity
and to avoid duplicate estimates for operator recordkeeping practices
that are discussed in both manuals, the burden for all collection of
information recommendations for retail and foodservice operators are
estimated together in table 1 of this document, regardless of the
manual in which they appear. Collection of information recommendations
for regulators in the Regulator's Manual are listed separately in table
2 of this document.
The likely respondents to this collection of information are
operators and regulators of retail and foodservice establishments.
In the Federal Register of July 21, 2005 (70 FR 42072), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of the collection of information as
follows:
[[Page 76057]]
Table 1.--Estimated Annual Recordkeeping Burden for Operators\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Types of Records Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
Food Safety 50,000\2\ 1 50,000 60 3,000,000
Management
System
--------------------------------------
------------------=======================================
------------------=======================================
------------------=======================================
------------------====================
------------------====================
--------------------------------------
Total First Year Burden\4\: 26,100,000
------------------ --------------------------------------------------------
----------------------------------------------------------------------------------------------
Risk Control Plan 50,000 1 50,000 2 100,000
------------------=======================================
------------------=======================================
------------------====================
--------------------------------------
Annual Burden\5\ 4,600,000
------------------ --------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
\2\ First year burden only.
\3\ Annual burden.
\4\ Burden for developing and implementing a food safety management system based on the Operator's Manual.
\5\ Annual burden for developing and implementing a risk control plan based on the Regulator's Manual.
The burden for these activities may vary among retail and
foodservice operators depending on the type and number of products
involved, the complexity of an establishment's operation, the nature of
the equipment or instruments required to monitor critical control
points, and the extent to which an operator uses the Operator's Manual
and/or the Regulator's Manual. The estimate does not include
collections of information that are a usual and customary part of an
operator's normal activities. FDA has established as a goal to have
50,000 (1/2 of 1 percent) of the approximately one million U.S. retail
and foodservice operators implement the recommendations outlined in the
two manuals. This target figure is used in calculating the burden in
tables 1 and 2 of this document because the agency lacks data on how to
base an estimate of how many retail and foodservice establishments are
likely to use one or more of the manuals to voluntarily implement a
comprehensive food safety management system based on HACCP principles
or a risk control plan for out-of-control processes identified during
an inspection. FDA's estimate of the total number of retail and
foodservice establishments is based on numbers obtained from the two
major trade organizations representing these industries, the Food
Marketing Institute and the National Restaurant Association,
respectively. FDA seeks comments on this estimate.
The hour burden estimates in table 1 of this document for operators
who follow the HACCP-based recommendations in the Operator's Manual are
based on the estimated average annual information collection burden for
mandatory HACCP rules, including seafood HACCP (60 FR 65096 at 65178,
December 18, 1995) and juice HACCP (66 FR 6138 at 6202, January 19,
2001). FDA estimates that during the first year, 20 labor hours are
needed to conduct the hazard analysis and 60 labor hours are needed to
develop a food safety management system (HACCP plan). Once the system
is in place, the annual frequency of records is based on 365 operating
days per year. Assuming there is one recordkeeper per shift of
operation, the agency estimates that two recordkeepers per day would be
needed to conduct monitoring, corrective action, recordkeeping, and
verification outlined in the system. The agency further estimates that
validation will be conducted once per year, based on menu or food list
changes, changes in distributors, or changes in food preparation
processes used. The validation will require a total of 4 labor hours.
The second set of estimates in table 1 of this document shows the
annual burden for developing and implementing a risk control plan to
control specific out-of-control foodborne illness risk factors
identified during an inspection by a State, local, or tribal regulatory
authority. If an operator decides to use a risk control plan as
recommended in the Regulator's Manual, one person from the
establishment is needed to work with the regulator to develop the
written plan. FDA estimates that two recordkeepers per day (one
recordkeeper for each shift) would be needed to conduct monitoring,
corrective action, recordkeeping, and verification outlined in the risk
control plan. The estimated duration of
[[Page 76058]]
implementation for a risk control plan is 90 days, which is the minimum
recommended time to achieve long-term behavior change.
Table 2.--Estimated Annual Recordkeeping Burden for Regulators\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Types of Records Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
Voluntary Food Safety 50,000 1 50,000 16 800,000
Management System Evaluation
(includes validation,
verification, and completion
of verification inspection
checklist)
----------------------------------------------------
Total Annual Burden for Regulators 800,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
It is difficult to predict the number of State, local, and tribal
regulatory jurisdictions that will use the Regulator's Manual. But FDA
anticipates that retail and foodservice establishments which
voluntarily develop and implement a food safety management system based
on the Operator's Manual will request their regulatory authorities to
conduct an evaluation of their system. The estimates in table 2 of this
document for the annual burden to State, local, and tribal regulators
that follow the recommendations in the Regulator's Manual were
calculated based on the usual time needed for one person to evaluate a
voluntarily-implemented food safety management system and record the
findings. The number of times an inspector may be asked by an operator
to evaluate a voluntarily-implemented system is not expected to exceed
once per year.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7644 Filed 12-21-05; 8:45 am]
BILLING CODE 4160-01-S
