Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013-2022), 65555-65560 [2012-26472]
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Federal Register / Vol. 77, No. 209 / Monday, October 29, 2012 / Notices
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other committee management activities, for
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both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: October 22, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2012–26490 Filed 10–26–12; 8:45 am]
Dated: October 22, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
BILLING CODE 4163–18–P
[FR Doc. 2012–26495 Filed 10–26–12; 8:45 am]
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[Docket No. FDA–2012–N–0547]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis (ACET)
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates: 8:30 a.m.–5:30 p.m.,
December 4, 2012; 8:30 a.m.–2:30 p.m.,
December 5, 2012.
Place: CDC, Corporate Square, 1800
Corporate Boulevard, Building 8, 1st Floor
Conference Room, Atlanta, Georgia 30329,
Telephone: (404) 639–8317.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 100 people.
Purpose: This council advises and makes
recommendations to the Secretary of Health
and Human Services, the Assistant Secretary
for Health, and the Director, CDC, regarding
the elimination of tuberculosis. Specifically,
the Council makes recommendations
regarding policies, strategies, objectives, and
priorities; addresses the development and
application of new technologies; and reviews
the extent to which progress has been made
toward eliminating tuberculosis.
Matters To Be Discussed: Agenda items
include the following topics: (1) CDC’s efforts
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epidemiology of TB–HIV in the United
States; (3) Post-deployment tuberculosis in
the United States military; (4) ACET
workgroups activities updates; and (5) other
tuberculosis-related issues.
Agenda items are subject to change as
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Contact Person for More Information:
Margie Scott-Cseh, CDC, 1600 Clifton Road
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The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Retail and
Foodservice Facility Types (2013–
2022)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
DATES: Fax written comments on the
collection of information by November
28, 2012.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Survey on the Occurrence of
Foodborne Illness Risk Factors in
Selected Retail and Foodservice Facility
Types (2013–2022).’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
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.
SUMMARY:
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Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Retail
and Foodservice Facility Types (2013–
2022)—(OMB Control Number 0910–
NEW)
I. Background
In 1998, the U.S. Food and Drug
Administration’s National Retail Food
Team initiated a 10-year voluntary
survey to measure trends in the
occurrence of foodborne illness risk
factors—preparation practices and
employee behaviors most commonly
reported to the Centers for Disease
Control and Prevention (CDC) as
contributing factors to foodborne illness
outbreaks at the retail level.
Specifically, the survey included data
collection inspections of various types
of retail and foodservice establishments
at 5-year intervals (1998, 2003, and
2008) in order to observe and document
trends in the occurrence of the
following foodborne illness risk factors:
• Food from Unsafe Sources.
• Poor Personal Hygiene.
• Inadequate Cooking.
• Improper Holding/Time and
Temperature.
• Contaminated Equipment/
Protection from Contamination.
FDA developed reports summarizing
the findings for each of the three data
collection periods (1998, 2003, and
2008) (Refs. 1 to 3). Data from all three
data collection periods were analyzed to
detect trends in improvement or
regression over time and to determine
whether progress had been made toward
the goal of reducing the occurrence of
foodborne illness risk factors in selected
retail and foodservice facility types (Ref.
4).
The research obtained from these
studies provides FDA a solid foundation
for developing a national retail food
program model that can be used by
Federal, State, local, and tribal agencies
to:
• Identify essential food safety
program performance measurements;
• Assess strengths and gaps in the
design, structure, and delivery of
program services;
• Establish program priorities and
intervention strategies focused on
reducing the occurrence of foodborne
illness risk factors; and
• Create a mechanism that justifies
program resources and allocates them to
program areas that will provide the most
significant public health benefits.
Using this 10-year survey as a
foundation, FDA is proposing to
conduct a new voluntary survey
encompassing annual data collections
over a 10-year period. The survey will
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determine the following for each facility
type included in the study:
• The foodborne illness risk factors
that are in most need of priority
attention during each data collection
period;
• Trends of improvement or
regression in foodborne illness risk
factor occurrence over time; and
• The impact of industry food safety
management systems in controlling the
occurrence of foodborne illness risk
factors.
The results of the proposed study will
be used to:
• Formulate Agency retail food safety
policies and initiatives;
• Identify retail food work plan
priorities and allocate resources to
enhance retail food safety nationwide;
• Generate nationally representative
estimates of the progress being made to
reduce the occurrence of foodborne
illness risk factors in retail and
foodservice establishments; and
• Recommend best practices and
targeted intervention strategies to assist
the retail and foodservice industry and
state, local, and tribal regulators with
reducing foodborne illness risk factors.
The statutory basis for FDA
conducting this survey is the Public
Health Service Act (the PHS Act) (42
U.S.C 243, section 311(a)) (Also 21 CFR
5.10(a)(2) and (4)), which requires that
FDA provide assistance to state and
local governments relative to the
prevention and suppression of
communicable diseases. In addition, the
PHS Act requires that FDA cooperate
with and aid state and local authorities
in the enforcement of their health
regulations and provide advice on
matters relating to the preservation and
improvement of public health.
Additionally, the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301) and
Economy Act (31 U.S.C. 1535) require
that FDA provide assistance to other
Federal, State, and local governmental
bodies.
In early 2013, FDA will conduct a
pilot data collection to practice the use
of the data collection form and methods
and test exportation of the pilot data
into a central repository. Following the
pilot, the Agency plans to conduct
annual data collections beginning in
2013 with the initial data collection for
select restaurant facility types, followed
by the initial data collection for select
institutional foodservice facility types in
2014 and select retail food store facility
types in 2015. The results of the initial
data collection for each of the facility
types will serve as the baseline
measurement from which trends will be
analyzed. Two additional data
collection periods for each of the facility
types are planned at 3-year intervals
after the initial data collection for
purposes of analyzing trends.
TABLE 1—SUMMARY OF DATA COLLECTION TIMEFRAMES 1
Year for initial
data collection
(baseline
measurement)
Industry segment
Facility types included in the survey
Restaurants ...............................
Full Service Restaurants ....................................
Fast Food Restaurants.
Hospitals .............................................................
Nursing Homes ..................................................
Elementary Schools (K–5) .................................
Deli Departments/Stores ....................................
Meat & Poultry Departments/Markets ................
Seafood Departments/Markets ..........................
Produce Departments/Markets ..........................
Institutional Foodservice ...........
Retail Food Stores ....................
Second data
collection period
Third and final
data collection
period
2013
2016
2019
2014
2017
2020
2015
2018
2021
1 Data collections for each of the facility types within an industry segment will be conducted using a 3-year interval period. Initial data collection
will serve as the baseline. Subsequent collections will provide the data needed to analyze trends.
A description of the facility types
included in the proposed survey is
included in table 2:
TABLE 2—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
Industry segment
Facility type
Description
Restaurants ...........................
Full Service Restaurants ............................
Establishments where customers place their order at their table, are
served their meal at the table, receive the service of the wait
staff, and pay at the end of the meal.
Also referred to as quick service restaurants and defined as any
restaurant that is not a full service restaurant.
Foodservice operations that serve patients, staff, and hospital visitors in a traditional hospital setting. Individuals who are acutely ill
to those who are immunocompromised are a target population for
data collection.
Foodservice operations that serve highly susceptible populations living in a group care setting. The elderly (55+ years) is the target
population for the data collection. Also includes assisted living facilities.
Foodservice operations that serve students from one or more grade
levels from preschool through grade 5. Young children are a target population for the data collection.
Fast Food Restaurants ..............................
Institutional Foodservice .......
Hospitals .....................................................
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Nursing Homes ..........................................
Elementary Schools (K–5) .........................
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TABLE 2—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY—Continued
Industry segment
Facility type
Description
Retail Food Stores ................
Deli Departments/Stores ............................
Departments in retail food stores where potentially hazardous foods
(time/temperature control for safety foods) such as luncheon
meats and cheeses are sliced for the customer and where sandwiches and salads are prepared on site or received from a commissary in bulk containers, portioned, and displayed. Freestanding cheese shops are categorized as delis. Parts of the deli
may also include:
• Salad bars and other food bars maintained by the deli department manager;
• Areas where meat or poultry are cooked and offered for sale
as ready-to-eat;
• Pizza stands; and
• Limited bakery operations attached to or adjacent to the deli.
Meat and poultry departments in a retail food store, as well as any
freestanding meat market or butcher shop that sells raw meat or
poultry directly to the consumer.
Seafood departments in retail food stores and freestanding seafood
markets that sell seafood directly to the consumer including the
preparation and sale of raw and/or ready-to-eat seafood. In-store
sushi bars are considered part of the seafood department for the
purposes of the data collection.
Areas or departments where produce is cut, prepared, stored, or
displayed. A produce department may include salad bars that are
managed by the produce manager, as well as juicers.
Meat and Poultry Departments/Markets ....
Seafood Departments/Markets ..................
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Produce Departments/Markets ..................
A geographical information system
database containing a listing of
businesses throughout the United States
will be used as the establishment
inventory for the data collections. FDA’s
Center for Food Safety and Applied
Nutrition (CFSAN) Biostatistical
Branch, in collaboration with the FDA
National Retail Food Team, will perform
a series of filtering processes of the
various database food establishment
categories to ensure establishments are
correctly classified and considered
eligible to participate in the survey
based on the descriptions in table 2.
To further determine the pool of
establishments eligible for selection, an
effort will be made to exclude
operations that handle only
prepackaged food items or conduct lowrisk food preparation activities. The
FDA Food Code contains a grouping of
establishments by risk, based on the
type of food preparation that is normally
conducted within the operation (Ref. 5).
The vast majority of selected
establishments are to be chosen from
risk categories 2 through 4.
FDA has approximately 25 Regional
Retail Food Specialists (Specialists) who
will serve as the data collectors for the
10-year study. The Specialists are
geographically dispersed throughout the
United States and possess technical
expertise in retail food safety and a solid
understanding of the operations within
each of the facility types to be surveyed.
The Specialists are also standardized by
FDA’s CFSAN personnel in the
application and interpretation of the
FDA Food Code (Ref. 5). The
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geographical distribution of Specialists
throughout the United States allows for
a broad sampling of facility types in all
regions of the United States; therefore,
establishments will be randomly
selected to participate in the study from
among all eligible establishments
located within a 150-mile radius of each
of the Specialists’ home locations.
The pilot will include approximately
4 data collection inspections for each of
the approximately 25 Specialists, or a
total of 100 inspections. In order to
obtain a sufficient number of
observations to conduct statistically
significant analysis, the FDA CFSAN
Biostatistical Branch has determined,
based on the previous 10-year foodborne
illness risk factor study that was
performed, that approximately 400 data
collection inspections of each facility
type are needed during the initial and
subsequent data collection periods. The
sample for each data collection period
will be evenly distributed among
Specialists. Given that participation in
the study by industry is voluntary and
the status of any given randomly
selected establishment is subject to
change, substitute establishments will
be selected for each Specialist for cases
in which the restaurant facility is
misclassified, closed, or otherwise
unavailable, unable, or unwilling to
participate.
Prior to conducting the data
collection, Specialists will contact the
state or local jurisdiction that has
regulatory responsibility for conducting
retail food inspections for the selected
establishment. The Specialist will verify
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with the jurisdiction that the facility has
been properly classified for the
purposes of the study and is still in
operation. The Specialist will also
ascertain whether the selected facility is
under legal notice from the state or local
regulatory authority. If the selected
facility is under legal notice, the
Specialist will not conduct a data
collection and a substitute
establishment will be used. An
invitation will be extended to the state
or local regulatory authority to
accompany the Specialist on the data
collection visit.
A standard data collection form will
be used by the Specialists during each
inspection. The form is divided into
three sections: Section 1—Establishment
Information; Section 2—Regulatory
Authority Information; and Section 3—
Foodborne Illness Risk Factor and Food
Safety Management System Assessment.
Section 3 includes three parts (parts A–
C) for tabulating the Specialists’
observations of the food employees’
behaviors and practices in limiting
contamination, proliferation, and
survival of food safety hazards (part A);
the industry food safety management
being implemented by the facility (part
B); and the frequency of food employee
hand washing (part C).
In completing Section 1—
Establishment Information of the form,
Specialists will ask a standardized set of
questions to the establishment owner or
person in charge. In completing Section
2—Regulatory Authority Information,
the Specialist will ask a standardized set
of questions to the program director (or
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other designed personnel) of the state or
local jurisdiction that has regulatory
responsibility for conducting
inspections for the selected
establishment. The information for
completing Section 3, part A of the form
will be collected from the Specialists’
direct observations of food employee
behaviors and practices, supplemented
by infrequent, nonstandardized
questions to industry personnel when
clarification is needed of the food safety
procedure or practice being observed.
For Section 3, part B of the form,
Specialists will ask industry
management a standardized set of
questions to obtain information on the
extent to which the food establishments
have developed and implemented food
safety management systems. Section 3,
part C of the form will involve only
direct observations of hand washing
frequency by the Specialists. No
questions will be asked in the
completion of this part of the form.
In the Federal Register of June 19,
2012 (77 FR 36544), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. There were five comments
received:
(Comment 1) Jane Public commented
that she does not see the usefulness of
the study. She also commented that
most foodborne illness resulting from
food from unsafe sources was caused by
agribusiness. She commented that
having a Web site on which the public
or doctors treating the sick and deceased
can post information about foodborne
illness would be more effective and
targeted than the data collection being
proposed by FDA.
(Response) FDA believes that many of
the comments made by this submitter
are unrelated to the proposed data
collection. Relative to the suggestion to
have a Web site on which the public or
doctors treating the sick or deceased can
post information about foodborne
illness, surveillance systems like this
are already used in the United States to
provide information about the
occurrence of foodborne disease
including, but not limited to, the
following: Foodborne Disease Active
Surveillance Network (FoodNet);
National Antimicrobial Resistance
Monitoring System—enteric bacteria
(NARMS); National Electronic
Norovirus Outbreak Network
(CaliciNet); National Molecular
Subtyping Network for Foodborne
Disease Surveillance (PulseNet);
National Notifiable Diseases
Surveillance System (NNDSS); National
Outbreak Reporting System (NORS);
Environmental Health Specialists
Network (EHS-Net); and the Public
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Health Laboratory Information System
(PHLIS). While each surveillance system
plays an important role in detecting and
preventing foodborne disease and
outbreaks, surveillance statistics reflect
only a fraction of the cases that occur in
the community. This is because
foodborne illnesses are largely
underdiagnosed and underreported. In
addition, surveillance statistics are, by
nature, reactive, meaning information is
obtained on foodborne illness that has
already occurred. In contrast, the data
collection proposed by FDA is proactive
in nature because it seeks to collect data
on the behaviors and practices that
could lead to foodborne illness or
deaths if not controlled. Using this data,
FDA will formulate and implement
intervention strategies to proactively
reduce foodborne illness risk factors
that lead to illness or death if not
controlled. For these reasons, FDA does
not agree with the submitter that
another surveillance-type reporting
system would be more effective or
targeted than the data collection being
proposed by FDA.
(Comment 2) The Food Marketing
Institute (FMI) commented that FDA
appears to have underestimated the
amount of time needed at 15 minutes
per event. The commenter states that
based on the retail industry’s experience
during the last survey (2008), the time
spent collecting and monitoring data
points took up 120 minutes per event
per retail grocer, and this caused an
undue interruption to business
operations and passed on unnecessary
costs to those surveyed.
(Response) OMB’s regulations at 5
CFR 1320.3(h) define the term
‘‘information.’’ Numbered paragraphs
under (h) list categories of data that are
not ‘‘information,’’ and thus do not
require OMB approval under the PRA.
Under paragraph (h)(3), ‘‘[f]acts or
opinions obtained through direct
observation by an employee or agent of
the sponsoring agency or through
nonstandardized oral communication in
connection with such direct
observations,’’ is not ‘‘information
collection’’ subject to OMB approval
under the PRA. Thus, the estimate of
burden is not required to account for the
duration of the entire inspection since
the data collector’s questions will
largely be nonstandardized, oral
communication in connection with his
or her direct observations.
In contrast, information collected in
Sections 1 and 2 and Section 3, part B
of the data collection form is not
available to the data collectors by direct
observation together with
nonstandardized, oral communication
and can only be obtained by asking the
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establishment’s representatives to
respond to a set of standardized
questions. Thus, the burden is
accurately calculated based solely on
the time it will take for the data
collectors to interview the respondents
to complete these specific sections of
the form. However, in consideration of
FMI’s comment and recent data
collection training that was conducted
with FDA’s National Retail Food Team
in September 2012, FDA believes that
the original burden for the respondents
that was published in table 1 of the 60day notice may have been
underestimated. For this reason, FDA is
increasing the burden estimate for each
respondent to 30 minutes per response.
(Comment 3) FMI commented that
FDA is not aligned with CDC in the
development of the study. According to
CDC data, most foodborne illness
outbreaks occur in restaurants (39
percent compared to <1 percent
foodborne illness events occurring in
grocery stores as well as 21 percent
compared to <1 percent actual
foodborne illnesses occurring in grocery
stores). Based on the data, FMI believes
the study seems to put an unnecessary
burden on retail grocery stores as retail
grocery stores will be surveyed at a 4:1
ratio. The study should be more
balanced between the restaurants and
grocers.
(Response) FDA has kept and will
continue to keep key CDC staff informed
of the plans for and results of the Risk
Factor Study so that areas in which our
concurrent studies reinforce or run
counter to one another can be analyzed
and appropriate prevention-based
messages developed.
The proposed sample size for each
facility type is not intended to mirror
the respective burden of foodborne
illness caused by each type, but rather
represents the minimum number of
inspections needed to obtain the
number of observations needed to draw
statistically significant conclusions. If
FDA reduced the number of
establishments inspected for the retail
food store facility types, it is likely FDA
would not obtain the number of
observations needed to draw
statistically valid conclusions or have
the desired confidence level in the data
that is obtained.
The restaurant industry segment
includes two facility types, institutional
foodservice includes three facility types,
and the retail food store industry
segment includes four facility types.
While the total number of data
collection inspections in retail food
store segment will be higher than that
for the restaurant segment, the number
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of data collection inspections for each
facility type will be the same.
(Comment 4) FMI believes the
proposed study fails to meet FDA’s
Information Quality Guidelines and the
requirements of the Data Quality Act
because its structure will not provide
information of utility to the public or
the Agency as it is disproportionately
focused on retail food stores when
statistics indicate that far more
foodborne illness events occur in
restaurants.
(Response) Information dissemination
is an important part of FDA’s mission to
promote and protect the public health.
FDA recognizes that public access to
high quality information is critical to
achieving this mission and public input,
in turn, improves the quality of the
information we disseminate. Because of
the nature of this information, our goal
has been and remains to ensure that all
the information we disseminate meets
the high standards of quality (including
objectivity, utility, and integrity)
described in the OMB and HHS
Guidelines and the Data Quality Act
(DQA).
To that end, FDA does not agree with
FMI’s comment that the proposed
information collection fails to meet
FDA’s Information Quality Guidelines
and the requirements of the DQA. The
sample size in the proposed information
collection is not intended to mirror the
respective burden of foodborne illness
caused by each facility type. Rather, it
represents the minimum number of
inspections needed for each facility type
in order to obtain a sufficient number of
observations to draw statistically
significant conclusions. If FDA were to
reduce the sample size of the retail food
store facility types to be more reflective
of the burden of foodborne illness
caused by these entities, the quality of
the data would be compromised and its
utility would be severely limited. This
is because it would be unlikely that
FDA could obtain the number of
observations needed to draw
statistically valid conclusions or have
the desired confidence level in the
conclusions we are able to make.
(Comment 5) The American Meat
Institute Foundation (AMIF)
commented that they support FDA’s
proposed survey of selected retail and
foodservice facility types. According to
AMIF, the survey findings will have
practical utility by enhancing the
knowledge of foodborne illness risk
factors in these types of facilities,
informing decisions for developing and
implementing risk mitigation strategies,
and guiding food safety resource
allocation. The followup data collection
periods will be useful tools to track
trends and benchmark improvements in
reducing risk factors.
(Response) FDA thanks the AMIF for
their comments and appreciates their
support in this undertaking.
Regarding the burden estimation, due
to the infrequent and nonstandard
nature of the questions that may or may
not be asked to clarify direct
observations made by the Specialists in
completing Section 3, parts A and C of
the data collection form, only the
burden associated with the information
collection related to the completion of
Sections 1 and 2 and Section 3, part B
of the form is included in burden
estimates. For each data collection, the
respondents will include the person in
charge of the selected facility and the
program director (or designated
individual) of the respective regulatory
authority. In consideration of FMI’s
comment to the 60-day notice and
recent data collection training that was
conducted with FDA’s National Retail
Food Team in September 2012, FDA
believes that the original burden that
was published in table 3 of the 60-day
notice may have been underestimated.
For this reason, FDA is increasing the
burden estimate for each respondent by
15 minutes per response. For the pilot,
25 Specialists will conduct 4 data
collection inspections; thus, FDA
estimates the number of respondents to
be 200 (25 Specialists × 4 data collection
inspections × 2 respondents per data
collection). The estimate of the hours
per response is based on its previous
experience with collecting similar
information in previous data collection
efforts. We estimate that it will take
each of the respondents 30 minutes (0.5
hours) to answer the questions related to
Sections 1 and 2 and Section 3, part B
of the form, for a total of 100 hours. FDA
bases its estimate of the number of
respondents during the subsequent
activities (data collections) on 400
inspections being conducted in each
facility type. FDA CFSAN’s
Biostatistical Branch has determined
that 400 inspections are necessary to
provide the sufficient number of
observations needed to conduct a
statistically significant analysis of the
data. The data collections in the
Restaurant Segment will occur in 2013,
2016, and 2019 and will each consist of
1,600 respondents. We estimate that it
will take each respondent 30 minutes
(0.5 hours) to answer the questions
related to Sections 1 and 2 and Section
3, part B of the form, for a total of 800
hours. The data collections in the
Institutional Foodservice Segment will
occur in 2014, 2017, and 2020 and will
each consist of 2,400 respondents. We
estimate that it will take each
respondent 30 minutes (0.5 hours) to
answer the questions related to Sections
1 and 2 and Section 3, part B of the
form, for a total of 1,200 hours. The data
collections in the Retail Food Store
Segment will occur in 2015, 2018, and
2021 and will each consist of 3,200
respondents. We estimate that it will
take a respondent 30 minutes (0.5
hours) to answer the questions related to
Sections 1 and 2 and Section 3, part B
of the form, for a total of 1,600 hours.
Thus, the total estimated burden is
10,900 hours.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
rmajette on DSK2TPTVN1PROD with
Pilot Data Collection to Practice Use of Form and Methods and Exportation of Data into Central Repository ....
2013 Baseline Data Collection—Restaurant Segment (includes two facility types) ................................................
2014 Baseline Data Collection—Institutional Foodservice
Segment (includes three facility types) ..........................
2015 Baseline Data Collection—Retail Food Store Segment (includes four facility types) ..................................
2016 Second Data Collection—Restaurant Segment (includes two facility types) ................................................
2017 Second Data Collection—Institutional Foodservice
Segment (includes three facility types) ..........................
VerDate Mar<15>2010
13:18 Oct 26, 2012
Number of
responses per
respondent
Number of
respondents
Activity
Jkt 229001
PO 00000
Frm 00029
Total annual
responses
Average burden
per response
Total hours
200
1
200
0.5
100
1,600
1
1,600
2 0.5
800
2,400
1
2,400
2 0.5
1,200
3,200
1
3,200
2 0.5
1,600
1,600
1
1,600
2 0.5
800
2,400
1
2,400
2 0.5
1,200
Fmt 4703
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Federal Register / Vol. 77, No. 209 / Monday, October 29, 2012 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Total hours
2018 Second Data Collection—Retail Food Store Segment (includes four facility types) ..................................
2019 Third and Final Data Collection—Restaurant Segment (includes two facility types) ...................................
2020 Third and Final Data Collection—Institutional
Foodservice Segment (includes three facility types) .....
2021 Third and Final Data Collection—Retail Food Store
Segment (includes four facility types) ............................
3,200
1
3,200
2
0.5
1,600
1,600
1
1,600
2 0.5
800
2,400
1
2,400
2 0.5
1,200
3,200
1
3,200
2 0.5
1,600
Total ............................................................................
........................
........................
........................
............................
10,900
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 30 minutes.
II. References
rmajette on DSK2TPTVN1PROD with
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Report of the FDA Retail Food Program
Steering Committee, ‘‘Database of Foodborne
Illness Risk Factors (2000).’’ Available at:
https://www.fda.gov/Food/FoodSafety/Retail
FoodProtection/FoodCode/FoodCode2001/
ucm123544.htm.
2. ‘‘FDA Report on the Occurrence of
Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2004).’’
Available at: https://www.fda.gov/Food/Food
Safety/RetailFoodProtection/Foodborne
IllnessandRiskFactorReduction/RetailFood
RiskFactorstudies/ucm089696.htm.
3. ‘‘FDA Report on the Occurrence of
Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2009).’’
Available at: https://www.fda.gov/downloads/
Food/FoodSafety/RetailFoodProtection/Food
borneIllnessRiskFactorReduction/RetailFood
RiskFactorStudies/ucm224682.pdf.
4. FDA National Retail Food Team, ‘‘FDA
Trend Analysis Report on the Occurrence of
Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (1998–
2008).’’ Available at:
https://www.fda.gov/Food/FoodSafety/Retail
FoodProtection/FoodborneIllnessandRisk
FactorReduction/RetailFoodRiskFactor
Studies/ucm223293.htm.
5. ‘‘FDA Food Code.’’ Available at:
https://www.fda.gov/Food/FoodSafety/Retail
FoodProtection/FoodCode/default.htm.
VerDate Mar<15>2010
13:18 Oct 26, 2012
Jkt 229001
Dated: October 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–26472 Filed 10–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0559]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Public Health
Service Guideline on Infectious
Disease Issues in Xenotransplantation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
DATES: Fax written comments on the
collection of information by November
28, 2012.
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0456. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
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.
PHS Guideline on Infectious Disease
Issues in Xenotransplantation—(OMB
Control Number 0910–0456)—Extension
The statutory authority to collect this
information is provided under sections
351 and 361 of the Public Health
Service (PHS) Act (42 U.S.C. 262 and
264) and the provisions of the Federal
Food, Drug, and Cosmetic Act that
apply to drugs (21 U.S.C. 301 et seq.).
The PHS guideline recommends
procedures to diminish the risk of
transmission of infectious agents to the
xenotransplantation product recipient
and to the general public. The PHS
guideline is intended to address public
health issues raised by
xenotransplantation, through
identification of general principles of
prevention and control of infectious
diseases associated with
xenotransplantation that may pose a
hazard to the public health. The
collection of information described in
this guideline is intended to provide
general guidance on the following
topics: (1) The development of
xenotransplantation clinical protocols;
(2) the preparation of submissions to
FDA; and (3) the conduct of
xenotransplantation clinical trials. Also,
the collection of information will help
ensure that the sponsor maintains
important information in a crossreferenced system that links the relevant
records of the xenotransplantation
product recipient, xenotransplantation
product, source animal(s), animal
procurement center, and significant
nosocomial exposures. The PHS
E:\FR\FM\29OCN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Pages 65555-65560]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0547]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Retail and
Foodservice Facility Types (2013-2022)
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 (the PRA).
DATES: Fax written comments on the collection of information by
November 28, 2012.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Survey on the Occurrence of Foodborne Illness Risk Factors in
Selected Retail and Foodservice Facility Types (2013-2022).'' Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.
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.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Retail and Foodservice Facility Types (2013-2022)--(OMB Control Number
0910-NEW)
I. Background
In 1998, the U.S. Food and Drug Administration's National Retail
Food Team initiated a 10-year voluntary survey to measure trends in the
occurrence of foodborne illness risk factors--preparation practices and
employee behaviors most commonly reported to the Centers for Disease
Control and Prevention (CDC) as contributing factors to foodborne
illness outbreaks at the retail level. Specifically, the survey
included data collection inspections of various types of retail and
foodservice establishments at 5-year intervals (1998, 2003, and 2008)
in order to observe and document trends in the occurrence of the
following foodborne illness risk factors:
Food from Unsafe Sources.
Poor Personal Hygiene.
Inadequate Cooking.
Improper Holding/Time and Temperature.
Contaminated Equipment/Protection from Contamination.
FDA developed reports summarizing the findings for each of the
three data collection periods (1998, 2003, and 2008) (Refs. 1 to 3).
Data from all three data collection periods were analyzed to detect
trends in improvement or regression over time and to determine whether
progress had been made toward the goal of reducing the occurrence of
foodborne illness risk factors in selected retail and foodservice
facility types (Ref. 4).
The research obtained from these studies provides FDA a solid
foundation for developing a national retail food program model that can
be used by Federal, State, local, and tribal agencies to:
Identify essential food safety program performance
measurements;
Assess strengths and gaps in the design, structure, and
delivery of program services;
Establish program priorities and intervention strategies
focused on reducing the occurrence of foodborne illness risk factors;
and
Create a mechanism that justifies program resources and
allocates them to program areas that will provide the most significant
public health benefits.
Using this 10-year survey as a foundation, FDA is proposing to
conduct a new voluntary survey encompassing annual data collections
over a 10-year period. The survey will
[[Page 65556]]
determine the following for each facility type included in the study:
The foodborne illness risk factors that are in most need
of priority attention during each data collection period;
Trends of improvement or regression in foodborne illness
risk factor occurrence over time; and
The impact of industry food safety management systems in
controlling the occurrence of foodborne illness risk factors.
The results of the proposed study will be used to:
Formulate Agency retail food safety policies and
initiatives;
Identify retail food work plan priorities and allocate
resources to enhance retail food safety nationwide;
Generate nationally representative estimates of the
progress being made to reduce the occurrence of foodborne illness risk
factors in retail and foodservice establishments; and
Recommend best practices and targeted intervention
strategies to assist the retail and foodservice industry and state,
local, and tribal regulators with reducing foodborne illness risk
factors.
The statutory basis for FDA conducting this survey is the Public
Health Service Act (the PHS Act) (42 U.S.C 243, section 311(a)) (Also
21 CFR 5.10(a)(2) and (4)), which requires that FDA provide assistance
to state and local governments relative to the prevention and
suppression of communicable diseases. In addition, the PHS Act requires
that FDA cooperate with and aid state and local authorities in the
enforcement of their health regulations and provide advice on matters
relating to the preservation and improvement of public health.
Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301)
and Economy Act (31 U.S.C. 1535) require that FDA provide assistance to
other Federal, State, and local governmental bodies.
In early 2013, FDA will conduct a pilot data collection to practice
the use of the data collection form and methods and test exportation of
the pilot data into a central repository. Following the pilot, the
Agency plans to conduct annual data collections beginning in 2013 with
the initial data collection for select restaurant facility types,
followed by the initial data collection for select institutional
foodservice facility types in 2014 and select retail food store
facility types in 2015. The results of the initial data collection for
each of the facility types will serve as the baseline measurement from
which trends will be analyzed. Two additional data collection periods
for each of the facility types are planned at 3-year intervals after
the initial data collection for purposes of analyzing trends.
Table 1--Summary of Data Collection Timeframes \1\
----------------------------------------------------------------------------------------------------------------
Year for initial
Facility types data collection Second data Third and final
Industry segment included in the (baseline collection period data collection
survey measurement) period
----------------------------------------------------------------------------------------------------------------
Restaurants...................... Full Service 2013 2016 2019
Restaurants.
Fast Food
Restaurants.
Institutional Foodservice........ Hospitals........... 2014 2017 2020
Nursing Homes.......
Elementary Schools
(K-5).
Retail Food Stores............... Deli Departments/ 2015 2018 2021
Stores.
Meat & Poultry
Departments/Markets.
Seafood Departments/
Markets.
Produce Departments/
Markets.
----------------------------------------------------------------------------------------------------------------
\1\ Data collections for each of the facility types within an industry segment will be conducted using a 3-year
interval period. Initial data collection will serve as the baseline. Subsequent collections will provide the
data needed to analyze trends.
A description of the facility types included in the proposed survey
is included in table 2:
Table 2--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
Industry segment Facility type Description
------------------------------------------------------------------------
Restaurants.................. Full Service Establishments where
Restaurants. customers place their
order at their table,
are served their meal
at the table, receive
the service of the wait
staff, and pay at the
end of the meal.
Fast Food Also referred to as
Restaurants. quick service
restaurants and defined
as any restaurant that
is not a full service
restaurant.
Institutional Foodservice.... Hospitals...... Foodservice operations
that serve patients,
staff, and hospital
visitors in a
traditional hospital
setting. Individuals
who are acutely ill to
those who are
immunocompromised are a
target population for
data collection.
Nursing Homes.. Foodservice operations
that serve highly
susceptible populations
living in a group care
setting. The elderly
(55+ years) is the
target population for
the data collection.
Also includes assisted
living facilities.
Elementary Foodservice operations
Schools (K-5). that serve students
from one or more grade
levels from preschool
through grade 5. Young
children are a target
population for the data
collection.
[[Page 65557]]
Retail Food Stores........... Deli Departments in retail
Departments/ food stores where
Stores. potentially hazardous
foods (time/temperature
control for safety
foods) such as luncheon
meats and cheeses are
sliced for the customer
and where sandwiches
and salads are prepared
on site or received
from a commissary in
bulk containers,
portioned, and
displayed. Freestanding
cheese shops are
categorized as delis.
Parts of the deli may
also include:
Salad bars
and other food bars
maintained by the
deli department
manager;
Areas where
meat or poultry are
cooked and offered
for sale as ready-to-
eat;
Pizza
stands; and
Limited
bakery operations
attached to or
adjacent to the
deli.
Meat and Meat and poultry
Poultry departments in a retail
Departments/ food store, as well as
Markets. any freestanding meat
market or butcher shop
that sells raw meat or
poultry directly to the
consumer.
Seafood Seafood departments in
Departments/ retail food stores and
Markets. freestanding seafood
markets that sell
seafood directly to the
consumer including the
preparation and sale of
raw and/or ready-to-eat
seafood. In-store sushi
bars are considered
part of the seafood
department for the
purposes of the data
collection.
Produce Areas or departments
Departments/ where produce is cut,
Markets. prepared, stored, or
displayed. A produce
department may include
salad bars that are
managed by the produce
manager, as well as
juicers.
------------------------------------------------------------------------
A geographical information system database containing a listing of
businesses throughout the United States will be used as the
establishment inventory for the data collections. FDA's Center for Food
Safety and Applied Nutrition (CFSAN) Biostatistical Branch, in
collaboration with the FDA National Retail Food Team, will perform a
series of filtering processes of the various database food
establishment categories to ensure establishments are correctly
classified and considered eligible to participate in the survey based
on the descriptions in table 2.
To further determine the pool of establishments eligible for
selection, an effort will be made to exclude operations that handle
only prepackaged food items or conduct low-risk food preparation
activities. The FDA Food Code contains a grouping of establishments by
risk, based on the type of food preparation that is normally conducted
within the operation (Ref. 5). The vast majority of selected
establishments are to be chosen from risk categories 2 through 4.
FDA has approximately 25 Regional Retail Food Specialists
(Specialists) who will serve as the data collectors for the 10-year
study. The Specialists are geographically dispersed throughout the
United States and possess technical expertise in retail food safety and
a solid understanding of the operations within each of the facility
types to be surveyed. The Specialists are also standardized by FDA's
CFSAN personnel in the application and interpretation of the FDA Food
Code (Ref. 5). The geographical distribution of Specialists throughout
the United States allows for a broad sampling of facility types in all
regions of the United States; therefore, establishments will be
randomly selected to participate in the study from among all eligible
establishments located within a 150-mile radius of each of the
Specialists' home locations.
The pilot will include approximately 4 data collection inspections
for each of the approximately 25 Specialists, or a total of 100
inspections. In order to obtain a sufficient number of observations to
conduct statistically significant analysis, the FDA CFSAN
Biostatistical Branch has determined, based on the previous 10-year
foodborne illness risk factor study that was performed, that
approximately 400 data collection inspections of each facility type are
needed during the initial and subsequent data collection periods. The
sample for each data collection period will be evenly distributed among
Specialists. Given that participation in the study by industry is
voluntary and the status of any given randomly selected establishment
is subject to change, substitute establishments will be selected for
each Specialist for cases in which the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
Prior to conducting the data collection, Specialists will contact
the state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist will verify with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist will also ascertain whether the selected
facility is under legal notice from the state or local regulatory
authority. If the selected facility is under legal notice, the
Specialist will not conduct a data collection and a substitute
establishment will be used. An invitation will be extended to the state
or local regulatory authority to accompany the Specialist on the data
collection visit.
A standard data collection form will be used by the Specialists
during each inspection. The form is divided into three sections:
Section 1--Establishment Information; Section 2--Regulatory Authority
Information; and Section 3--Foodborne Illness Risk Factor and Food
Safety Management System Assessment. Section 3 includes three parts
(parts A-C) for tabulating the Specialists' observations of the food
employees' behaviors and practices in limiting contamination,
proliferation, and survival of food safety hazards (part A); the
industry food safety management being implemented by the facility (part
B); and the frequency of food employee hand washing (part C).
In completing Section 1--Establishment Information of the form,
Specialists will ask a standardized set of questions to the
establishment owner or person in charge. In completing Section 2--
Regulatory Authority Information, the Specialist will ask a
standardized set of questions to the program director (or
[[Page 65558]]
other designed personnel) of the state or local jurisdiction that has
regulatory responsibility for conducting inspections for the selected
establishment. The information for completing Section 3, part A of the
form will be collected from the Specialists' direct observations of
food employee behaviors and practices, supplemented by infrequent,
nonstandardized questions to industry personnel when clarification is
needed of the food safety procedure or practice being observed. For
Section 3, part B of the form, Specialists will ask industry management
a standardized set of questions to obtain information on the extent to
which the food establishments have developed and implemented food
safety management systems. Section 3, part C of the form will involve
only direct observations of hand washing frequency by the Specialists.
No questions will be asked in the completion of this part of the form.
In the Federal Register of June 19, 2012 (77 FR 36544), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. There were five comments received:
(Comment 1) Jane Public commented that she does not see the
usefulness of the study. She also commented that most foodborne illness
resulting from food from unsafe sources was caused by agribusiness. She
commented that having a Web site on which the public or doctors
treating the sick and deceased can post information about foodborne
illness would be more effective and targeted than the data collection
being proposed by FDA.
(Response) FDA believes that many of the comments made by this
submitter are unrelated to the proposed data collection. Relative to
the suggestion to have a Web site on which the public or doctors
treating the sick or deceased can post information about foodborne
illness, surveillance systems like this are already used in the United
States to provide information about the occurrence of foodborne disease
including, but not limited to, the following: Foodborne Disease Active
Surveillance Network (FoodNet); National Antimicrobial Resistance
Monitoring System--enteric bacteria (NARMS); National Electronic
Norovirus Outbreak Network (CaliciNet); National Molecular Subtyping
Network for Foodborne Disease Surveillance (PulseNet); National
Notifiable Diseases Surveillance System (NNDSS); National Outbreak
Reporting System (NORS); Environmental Health Specialists Network (EHS-
Net); and the Public Health Laboratory Information System (PHLIS).
While each surveillance system plays an important role in detecting and
preventing foodborne disease and outbreaks, surveillance statistics
reflect only a fraction of the cases that occur in the community. This
is because foodborne illnesses are largely underdiagnosed and
underreported. In addition, surveillance statistics are, by nature,
reactive, meaning information is obtained on foodborne illness that has
already occurred. In contrast, the data collection proposed by FDA is
proactive in nature because it seeks to collect data on the behaviors
and practices that could lead to foodborne illness or deaths if not
controlled. Using this data, FDA will formulate and implement
intervention strategies to proactively reduce foodborne illness risk
factors that lead to illness or death if not controlled. For these
reasons, FDA does not agree with the submitter that another
surveillance-type reporting system would be more effective or targeted
than the data collection being proposed by FDA.
(Comment 2) The Food Marketing Institute (FMI) commented that FDA
appears to have underestimated the amount of time needed at 15 minutes
per event. The commenter states that based on the retail industry's
experience during the last survey (2008), the time spent collecting and
monitoring data points took up 120 minutes per event per retail grocer,
and this caused an undue interruption to business operations and passed
on unnecessary costs to those surveyed.
(Response) OMB's regulations at 5 CFR 1320.3(h) define the term
``information.'' Numbered paragraphs under (h) list categories of data
that are not ``information,'' and thus do not require OMB approval
under the PRA. Under paragraph (h)(3), ``[f]acts or opinions obtained
through direct observation by an employee or agent of the sponsoring
agency or through nonstandardized oral communication in connection with
such direct observations,'' is not ``information collection'' subject
to OMB approval under the PRA. Thus, the estimate of burden is not
required to account for the duration of the entire inspection since the
data collector's questions will largely be nonstandardized, oral
communication in connection with his or her direct observations.
In contrast, information collected in Sections 1 and 2 and Section
3, part B of the data collection form is not available to the data
collectors by direct observation together with nonstandardized, oral
communication and can only be obtained by asking the establishment's
representatives to respond to a set of standardized questions. Thus,
the burden is accurately calculated based solely on the time it will
take for the data collectors to interview the respondents to complete
these specific sections of the form. However, in consideration of FMI's
comment and recent data collection training that was conducted with
FDA's National Retail Food Team in September 2012, FDA believes that
the original burden for the respondents that was published in table 1
of the 60-day notice may have been underestimated. For this reason, FDA
is increasing the burden estimate for each respondent to 30 minutes per
response.
(Comment 3) FMI commented that FDA is not aligned with CDC in the
development of the study. According to CDC data, most foodborne illness
outbreaks occur in restaurants (39 percent compared to <1 percent
foodborne illness events occurring in grocery stores as well as 21
percent compared to <1 percent actual foodborne illnesses occurring in
grocery stores). Based on the data, FMI believes the study seems to put
an unnecessary burden on retail grocery stores as retail grocery stores
will be surveyed at a 4:1 ratio. The study should be more balanced
between the restaurants and grocers.
(Response) FDA has kept and will continue to keep key CDC staff
informed of the plans for and results of the Risk Factor Study so that
areas in which our concurrent studies reinforce or run counter to one
another can be analyzed and appropriate prevention-based messages
developed.
The proposed sample size for each facility type is not intended to
mirror the respective burden of foodborne illness caused by each type,
but rather represents the minimum number of inspections needed to
obtain the number of observations needed to draw statistically
significant conclusions. If FDA reduced the number of establishments
inspected for the retail food store facility types, it is likely FDA
would not obtain the number of observations needed to draw
statistically valid conclusions or have the desired confidence level in
the data that is obtained.
The restaurant industry segment includes two facility types,
institutional foodservice includes three facility types, and the retail
food store industry segment includes four facility types. While the
total number of data collection inspections in retail food store
segment will be higher than that for the restaurant segment, the number
[[Page 65559]]
of data collection inspections for each facility type will be the same.
(Comment 4) FMI believes the proposed study fails to meet FDA's
Information Quality Guidelines and the requirements of the Data Quality
Act because its structure will not provide information of utility to
the public or the Agency as it is disproportionately focused on retail
food stores when statistics indicate that far more foodborne illness
events occur in restaurants.
(Response) Information dissemination is an important part of FDA's
mission to promote and protect the public health. FDA recognizes that
public access to high quality information is critical to achieving this
mission and public input, in turn, improves the quality of the
information we disseminate. Because of the nature of this information,
our goal has been and remains to ensure that all the information we
disseminate meets the high standards of quality (including objectivity,
utility, and integrity) described in the OMB and HHS Guidelines and the
Data Quality Act (DQA).
To that end, FDA does not agree with FMI's comment that the
proposed information collection fails to meet FDA's Information Quality
Guidelines and the requirements of the DQA. The sample size in the
proposed information collection is not intended to mirror the
respective burden of foodborne illness caused by each facility type.
Rather, it represents the minimum number of inspections needed for each
facility type in order to obtain a sufficient number of observations to
draw statistically significant conclusions. If FDA were to reduce the
sample size of the retail food store facility types to be more
reflective of the burden of foodborne illness caused by these entities,
the quality of the data would be compromised and its utility would be
severely limited. This is because it would be unlikely that FDA could
obtain the number of observations needed to draw statistically valid
conclusions or have the desired confidence level in the conclusions we
are able to make.
(Comment 5) The American Meat Institute Foundation (AMIF) commented
that they support FDA's proposed survey of selected retail and
foodservice facility types. According to AMIF, the survey findings will
have practical utility by enhancing the knowledge of foodborne illness
risk factors in these types of facilities, informing decisions for
developing and implementing risk mitigation strategies, and guiding
food safety resource allocation. The followup data collection periods
will be useful tools to track trends and benchmark improvements in
reducing risk factors.
(Response) FDA thanks the AMIF for their comments and appreciates
their support in this undertaking.
Regarding the burden estimation, due to the infrequent and
nonstandard nature of the questions that may or may not be asked to
clarify direct observations made by the Specialists in completing
Section 3, parts A and C of the data collection form, only the burden
associated with the information collection related to the completion of
Sections 1 and 2 and Section 3, part B of the form is included in
burden estimates. For each data collection, the respondents will
include the person in charge of the selected facility and the program
director (or designated individual) of the respective regulatory
authority. In consideration of FMI's comment to the 60-day notice and
recent data collection training that was conducted with FDA's National
Retail Food Team in September 2012, FDA believes that the original
burden that was published in table 3 of the 60-day notice may have been
underestimated. For this reason, FDA is increasing the burden estimate
for each respondent by 15 minutes per response. For the pilot, 25
Specialists will conduct 4 data collection inspections; thus, FDA
estimates the number of respondents to be 200 (25 Specialists x 4 data
collection inspections x 2 respondents per data collection). The
estimate of the hours per response is based on its previous experience
with collecting similar information in previous data collection
efforts. We estimate that it will take each of the respondents 30
minutes (0.5 hours) to answer the questions related to Sections 1 and 2
and Section 3, part B of the form, for a total of 100 hours. FDA bases
its estimate of the number of respondents during the subsequent
activities (data collections) on 400 inspections being conducted in
each facility type. FDA CFSAN's Biostatistical Branch has determined
that 400 inspections are necessary to provide the sufficient number of
observations needed to conduct a statistically significant analysis of
the data. The data collections in the Restaurant Segment will occur in
2013, 2016, and 2019 and will each consist of 1,600 respondents. We
estimate that it will take each respondent 30 minutes (0.5 hours) to
answer the questions related to Sections 1 and 2 and Section 3, part B
of the form, for a total of 800 hours. The data collections in the
Institutional Foodservice Segment will occur in 2014, 2017, and 2020
and will each consist of 2,400 respondents. We estimate that it will
take each respondent 30 minutes (0.5 hours) to answer the questions
related to Sections 1 and 2 and Section 3, part B of the form, for a
total of 1,200 hours. The data collections in the Retail Food Store
Segment will occur in 2015, 2018, and 2021 and will each consist of
3,200 respondents. We estimate that it will take a respondent 30
minutes (0.5 hours) to answer the questions related to Sections 1 and 2
and Section 3, part B of the form, for a total of 1,600 hours. Thus,
the total estimated burden is 10,900 hours.
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pilot Data Collection to 200 1 200 0.5 100
Practice Use of Form and
Methods and Exportation of Data
into Central Repository........
2013 Baseline Data Collection-- 1,600 1 1,600 \2\ 0.5 800
Restaurant Segment (includes
two facility types)............
2014 Baseline Data Collection-- 2,400 1 2,400 \2\ 0.5 1,200
Institutional Foodservice
Segment (includes three
facility types)................
2015 Baseline Data Collection-- 3,200 1 3,200 \2\ 0.5 1,600
Retail Food Store Segment
(includes four facility types).
2016 Second Data Collection-- 1,600 1 1,600 \2\ 0.5 800
Restaurant Segment (includes
two facility types)............
2017 Second Data Collection-- 2,400 1 2,400 \2\ 0.5 1,200
Institutional Foodservice
Segment (includes three
facility types)................
[[Page 65560]]
2018 Second Data Collection-- 3,200 1 3,200 \2\ 0.5 1,600
Retail Food Store Segment
(includes four facility types).
2019 Third and Final Data 1,600 1 1,600 \2\ 0.5 800
Collection--Restaurant Segment
(includes two facility types)..
2020 Third and Final Data 2,400 1 2,400 \2\ 0.5 1,200
Collection--Institutional
Foodservice Segment (includes
three facility types)..........
2021 Third and Final Data 3,200 1 3,200 \2\ 0.5 1,600
Collection--Retail Food Store
Segment (includes four facility
types).........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. ................ 10,900
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ 30 minutes.
II. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
1. Report of the FDA Retail Food Program Steering Committee,
``Database of Foodborne Illness Risk Factors (2000).'' Available at:
https://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2001/ucm123544.htm.
2. ``FDA Report on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2004).'' Available at: https://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorstudies/ucm089696.htm.
3. ``FDA Report on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2009).'' Available at: https://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/RetailFoodRiskFactorStudies/ucm224682.pdf.
4. FDA National Retail Food Team, ``FDA Trend Analysis Report on
the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and Retail Food Store
Facility Types (1998-2008).'' Available at: https://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm223293.htm.
5. ``FDA Food Code.'' Available at: https://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/default.htm.
Dated: October 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-26472 Filed 10-26-12; 8:45 am]
BILLING CODE 4160-01-P
