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, 11961-11963 [E9-6168]
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Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices
Dated: March 16, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–6031 Filed 3–19–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0641]
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 April 20,
2009.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0578. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
17:07 Mar 19, 2009
Jkt 217001
Voluntary Hazard Analysis and Critical
Control Point Manuals for Operators
and Regulators of Retail and Food
Service Establishments—(OMB Control
Number 0910–0578—Extension)
The 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 Hazard
Analysis and Critical Control Point
(HACCP) principles. Operators may
decide to incorporate some or all of the
principles presented in the manual into
their existing food safety management
systems. The recordkeeping practices
discussed in the 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 manual includes optional
worksheets to assist operators in
developing and validating a voluntary
food safety management system.
The 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
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: (1) Validation (assessing
whether the establishment’s voluntary
food safety management system is
adequate to control food safety hazards)
and (2) verification (assessing whether
the establishment is following its
voluntary food safety management
system). The manual includes a sample
entitled ‘‘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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
11961
following burden estimates include: (1)
Food safety management systems (plans
that delineate the formal procedures to
follow to control all food safety hazards
in an operation); (2) risk control plans
(HACCP-based, goal-oriented plans for
achieving active managerial control over
specific out-of-control foodborne illness
risk factors); (3) hazard analysis (written
assessment of the significant food safety
hazards associated with foods prepared
in the establishment); (4) 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); (5) monitoring (records
showing the observations or
measurements that are made to help
determine if critical limits are being met
and maintained); (6) corrective action
(records indicating the activities that are
completed whenever a critical limit is
not met); (7) 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 (8)
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.
Description of Respondents: The
likely respondents to this collection of
information are operators and regulators
of retail and foodservice establishments.
In the Federal Register of December
19, 2008 (73 FR 77721), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20MRN1.SGM
20MRN1
11962
Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices
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
Prerequisite Program Records
100,0002
365
36,500,000
0.1
3,650,000
Monitoring Records
100,0002
365
36,500,000
0.3
10,950,000
Corrective Action Records
100,0002
365
36,500,000
0.1
3,650,000
Ongoing Verification Records (includes calibration records)
100,0002
365
36,500,000
0.1
3,650,000
50,0002
1
50,000
Validation Records
4
Annual Burden3:
200,000
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 Burden4
100,000
4,600,000
Total Annual Burden for Operators
26,700,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Annual burden.
3 Burden for developing and implementing a food safety management system based on the Operator’s Manual.
4 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
(0.05 percent) of the approximately 1
million U.S. retail and foodservice
operators implement the
recommendations outlined in the 2
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 Nov<24>2008
17:07 Mar 19, 2009
Jkt 217001
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.
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 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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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
implementation for a risk control plan is
90 days, which is the minimum
recommended time to achieve long-term
behavior change.
E:\FR\FM\20MRN1.SGM
20MRN1
11963
Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices
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
50,000
Total Annual
Records
1
Hours per
Recordkeeper
50,000
Total Hours
16
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: March 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6168 Filed 3–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0136]
Draft Guidance for Industry on
Community-Acquired Bacterial
Pneumonia: Developing Drugs for
Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
800,000
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Community-Acquired
Bacterial Pneumonia: Developing Drugs
for Treatment.’’ This draft guidance
informs industry of FDA’s current
VerDate Nov<24>2008
17:07 Mar 19, 2009
Jkt 217001
thinking regarding the overall
development program and clinical trial
designs for drugs to support an
indication for treatment of communityacquired bacterial pneumonia (CABP).
This draft guidance does not address the
development of drugs for other purposes
or populations, such as treatment of
patients with hospital-acquired
pneumonia or ventilator-associated
pneumonia. This draft guidance revises
the draft guidance for industry entitled
‘‘Community-Acquired PneumoniaDeveloping Antimicrobial Drugs for
Treatment’’ published July 1998.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by June 18, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Sumathi Nambiar, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6232,
Silver Spring, MD 20993–0002,
301–796–1400; or
Edward Cox, Center for Drug
Evaluation and Research, 10903
New Hampshire Ave., Bldg. 22, rm.
6212, Silver Spring, MD 20993–
0002, 301–796–1300.
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Frm 00061
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Community-Acquired Bacterial
Pneumonia: Developing Drugs for
Treatment.’’ Since FDA published the
draft guidance on the development of
antimicrobial drugs for the treatment of
community-acquired pneumonia in
1998, there have been public
discussions regarding clinical trial
designs to study CABP, including an
FDA–Infectious Disease Society of
America (IDSA) workshop and a
meeting of the Anti-Infective Drugs
Advisory Committee. These discussions
have focused on clinical trial designs for
CABP and other important issues such
as the following:
• Noninferiority versus superiority
design
• Justification of an appropriate
noninferiority margin
• Classification of severity of illness
• Classification of CABP based on
hospitalization (inpatient versus
outpatient)
• Enrollment criteria
• Application of appropriate
diagnostic criteria, including
microbiologic diagnosis
• Use of appropriate definitions of
clinical outcomes, including mortality
• Timing of outcome assessments
• Use of prior antibacterial drugs
Important changes from the 1998 draft
guidance that are based on these
discussions have been incorporated into
this revised draft guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the development of antibacterial
drugs for CABP including appropriate
clinical trial designs to evaluate drugs
for the treatment of CABP. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
E:\FR\FM\20MRN1.SGM
20MRN1
]]>Agencies
[Federal Register Volume 74, Number 53 (Friday, March 20, 2009)]
[Notices]
[Pages 11961-11963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6168]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0641]
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 April
20, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0578.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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 Manuals for
Operators and Regulators of Retail and Food Service Establishments--
(OMB Control Number 0910-0578--Extension)
The 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 Hazard
Analysis and Critical Control Point (HACCP) principles. Operators may
decide to incorporate some or all of the principles presented in the
manual into their existing food safety management systems. The
recordkeeping practices discussed in the 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 manual includes optional worksheets to assist
operators in developing and validating a voluntary food safety
management system.
The 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 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: (1)
Validation (assessing whether the establishment's voluntary food safety
management system is adequate to control food safety hazards) and (2)
verification (assessing whether the establishment is following its
voluntary food safety management system). The manual includes a sample
entitled ``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: (1) Food safety management
systems (plans that delineate the formal procedures to follow to
control all food safety hazards in an operation); (2) risk control
plans (HACCP-based, goal-oriented plans for achieving active managerial
control over specific out-of-control foodborne illness risk factors);
(3) hazard analysis (written assessment of the significant food safety
hazards associated with foods prepared in the establishment); (4)
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); (5) monitoring (records showing the
observations or measurements that are made to help determine if
critical limits are being met and maintained); (6) corrective action
(records indicating the activities that are completed whenever a
critical limit is not met); (7) 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 (8) 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.
Description of Respondents: The likely respondents to this
collection of information are operators and regulators of retail and
foodservice establishments.
In the Federal Register of December 19, 2008 (73 FR 77721), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 11962]]
Table 1.--Estimated Annual Recordkeeping Burden for Operators\1\
----------------------------------------------------------------------------------------------------------------
Types of No. of Annual Frequency of Total Annual Hours per
Records Recordkeepers Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
Prerequisite 100,000\2\ 365 36,500,000 0.1 3,650,000
Program
Records
----------------------------------------------------------------------------------------------------------------
Monitoring 100,000\2\ 365 36,500,000 0.3 10,950,000
Records
----------------------------------------------------------------------------------------------------------------
Corrective 100,000\2\ 365 36,500,000 0.1 3,650,000
Action
Records
----------------------------------------------------------------------------------------------------------------
Ongoing 100,000\2\ 365 36,500,000 0.1 3,650,000
Verification
Records
(includes
calibration
records)
----------------------------------------------------------------------------------------------------------------
Validation 50,000\2\ 1 50,000 4 200,000
Records
----------------------------------------------------------------------------------------------------------------
Annual Burden\3\: 22,100,000
----------------------------------------------------------------------------------------------
Risk Control 50,000 1 50,000 2 100,000
Plan
----------------------------------------------------------------------------------------------------------------
Monitoring 100,000 90 9,000,000 0.3 2,700,000
Records
----------------------------------------------------------------------------------------------------------------
Corrective 100,000 90 9,000,000 0.1 900,000
Action
Records
----------------------------------------------------------------------------------------------------------------
Ongoing 100,000 90 9,000,000 0.1 900,000
Verification
Records
(includes
calibration
records)
----------------------------------------------------------------------------------------------------------------
Annual Burden\4\ 4,600,000
----------------------------------------------------------------------------------------------
Total Annual Burden for Operators 26,700,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Annual burden.
\3\ Burden for developing and implementing a food safety management system based on the Operator's Manual.
\4\ 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 (0.05 percent) of the approximately 1 million U.S. retail and
foodservice operators implement the recommendations outlined in the 2
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.
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 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 implementation for a risk
control plan is 90 days, which is the minimum recommended time to
achieve long-term behavior change.
[[Page 11963]]
Table 2.--Estimated Annual Recordkeeping Burden for Regulators\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
Types of Records Recordkeepers Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Food Safety Management System Evaluation 50,000 1 50,000 16 800,000
(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: March 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6168 Filed 3-19-09; 8:45 am]
BILLING CODE 4160-01-S
