Document ID: FDA-2012-N-0547-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Posted Date: 2012-10-29T04:00Z

[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]

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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 http://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: 
http://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: http://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: http://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: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm223293.htm.
    5. ``FDA Food Code.'' Available at: http://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