Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments, 77721-77723 [E8-30278]
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Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
Dated: December 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30280 Filed 12–18–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0641]
Agency Information Collection
Activities; Proposed Collection;
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 an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the agency’s Voluntary Hazard Analysis
and Critical Control Point Manuals for
Operators and Regulators of Retail and
Food Service Establishments.
DATES: Submit written or electronic
comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
VerDate Aug<31>2005
17:29 Dec 18, 2008
Jkt 217001
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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.
PO 00000
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Fmt 4703
Sfmt 4703
77721
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
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)
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Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR OPERATORS 1
No. of
Recordkeepers
Types of Records
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
Prerequisite Program Records
2 100,000
365
36,500,000
0.1
3,650,000
Monitoring Records
2 100,000
365
36,500,000
0.3
10,950,000
Corrective Action Records
2 100,000
365
36,500,000
0.1
3,650,000
Ongoing Verification Records (includes calibration records)
2 100,000
365
36,500,000
0.1
3,650,000
2 50,000
1
50,000
Validation Records
4
Annual Burden 3:
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 Burden 4
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 one
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
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implement a comprehensive food safety
management system based on HACCP
principles or a risk control plan for outof-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
PO 00000
Frm 00132
Fmt 4703
Sfmt 4703
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
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Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
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.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR REGULATORS 1
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30278 Filed 12–18–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:29 Dec 18, 2008
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0617]
Determination That RUBRAMIN PC
(Cyanocobalamin) Injection and Ten
Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that the eleven drug products listed in
this document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
the drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
andosage form as the ‘‘listed drug,’’
which is a version of the drug that was
PO 00000
Frm 00133
Fmt 4703
Sfmt 4703
previously approved. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355(j)(7)), which requires
FDA to publish a list of all approved
drugs. FDA publishes this list as part of
the ‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved; (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved; and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for reasons of
safety or effectiveness, the agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
(As requested by the applicant, FDA
withdrew approval of NDA 6–799 for
RUBRAMIN PC (cyanocobalamin)
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]]>Agencies
[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77721-77723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30278]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0641]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the agency's Voluntary Hazard Analysis and Critical
Control Point Manuals for Operators and Regulators of Retail and Food
Service Establishments.
DATES: Submit written or electronic comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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)
[[Page 77722]]
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.
FDA estimates the burden of this collection of information as
follows:
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
----------------------------------------------------------------------------------------------------------------
Prerequisite \2\ 100,000 365 36,500,000 0.1 3,650,000
Program Records
----------------------------------------------------------------------------------------------------------------
Monitoring \2\ 100,000 365 36,500,000 0.3 10,950,000
Records
----------------------------------------------------------------------------------------------------------------
Corrective Action \2\ 100,000 365 36,500,000 0.1 3,650,000
Records
----------------------------------------------------------------------------------------------------------------
Ongoing \2\ 100,000 365 36,500,000 0.1 3,650,000
Verification
Records
(includes
calibration
records)
----------------------------------------------------------------------------------------------------------------
Validation \2\ 50,000 1 50,000 4 200,000
Records
----------------------------------------------------------------------------------------------------------------
Annual Burden \3\: 22,100,000
----------------------------------------------------------------------------------------------------------------
Risk Control Plan 50,000 1 50,000 2 100,000
----------------------------------------------------------------------------------------------------------------
Monitoring 100,000 90 9,000,000 0.3 2,700,000
Records
----------------------------------------------------------------------------------------------------------------
Corrective Action 100,000 90 9,000,000 0.1 900,000
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 one 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
[[Page 77723]]
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.
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30278 Filed 12-18-08; 8:45 am]
BILLING CODE 4160-01-S
