[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64168-64171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22438]



[[Page 64168]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2033]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey on the Occurrence of Foodborne Illness Risk 
Factors in Selected Institutional Foodservice and Retail Food Stores 
Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a survey entitled ``Survey on 
the Occurrence of Foodborne Illness Risk Factors in Selected 
Institutional Foodservice and Retail Food Stores Facility Types (2015-
2025).''

DATES: Submit either electronic or written comments on the collection 
of information by November 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-2033 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Survey on the Occurrence of 
Foodborne Illness Risk Factors in Selected Institutional Foodservice 
and Retail Food Stores Facility Types.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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Survey on the Occurrence of Foodborne Illness Risk Factors in Selected 
Retail and Foodservice Facility Types (2015-2025)--OMB Control Number 
0910-0799--Extension

I. Background

    From 1998 to 2008, FDA's National Retail Food Team conducted a 
study 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 as 
contributing factors to foodborne illness outbreaks at the retail 
level. Specifically, data was collected by FDA Specialists in 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, and
     Contaminated Equipment/Cross-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).
    Using this 10-year survey as a foundation, in 2013-2014, FDA 
initiated a new study in full service and fast food restaurants. This 
study will span 10 years with additional data collections planned for 
2017-2018 and 2021-2022.
    FDA is currently collecting data in select institutional 
foodservice, schools, and retail food store facility types in 2015-
2016. This proposed study will also span 10 years with additional data 
collections planned for 2019-2020 and 2023-2024.
    The current data collection in selected institutional foodservice, 
schools, and retail food store facilities was initiated on October 1, 
2016, with a target date for completion by December 31, 2016. FDA is 
requesting a 90 day extension to complete this data collection by March 
31, 2017. The extension is being requested to ensure that the number of 
facilities included in the study provide a sufficient sample size to 
conduct statistically significant analysis.

    Table 1--Description of the Facility Types Included in the Survey
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           Facility type                         Description
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Health Care Facilities............  Hospitals and long-term care
                                     facilities foodservice operations
                                     that prepare meals for highly
                                     susceptible populations as defined
                                     as follows:
                                        Hospitals--A foodservice
                                        operation that provides for the
                                        nutritional needs of inpatients
                                        by preparing meals and
                                        transporting them to the
                                        patient's room and/or serving
                                        meals in a cafeteria setting
                                        (meals in the cafeteria may also
                                        be served to hospital staff and
                                        visitors).
                                        Long-term care
                                        facilities--A foodservice
                                        operation that prepares meals
                                        for the residents in a group
                                        care living setting such as
                                        nursing homes and assisted
                                        living facilities.
                                    Note: For the purposes of this
                                     study, health care facilities that
                                     do not prepare or serve food to a
                                     highly susceptible population, such
                                     as mental health care facilities,
                                     are not included in this facility
                                     type category.
Schools (K-12)....................  Foodservice operations that have the
                                     primary function of preparing and
                                     serving meals for students in one
                                     or more grade levels from
                                     kindergarten through grade 12. A
                                     school foodservice may be part of a
                                     public or private institution.
Retail Food Stores................  Supermarkets and grocery stores that
                                     have a deli department/operation as
                                     described as follows:
                                        Deli department/
                                        operation--Areas in a retail
                                        food store where foods, such as
                                        luncheon meats and cheeses, are
                                        sliced for the customers and
                                        where sandwiches and salads are
                                        prepared on-site or received
                                        from a commissary in bulk
                                        containers, portioned, and
                                        displayed. Parts of deli
                                        operations may include:
                                        Salad bars, pizza
                                        stations, and other food bars
                                        managed by the deli department
                                        manager.
                                        Areas where other foods
                                        are cooked or prepared and
                                        offered for sale as ready-to-eat
                                        and are managed by the deli
                                        department manager.
                                    Data will also be collected in the
                                     following areas of a supermarket or
                                     grocery store, if present:
                                        Meat and seafood
                                        department/operation--Areas in a
                                        retail food store where raw
                                        animal food products, such as
                                        beef, pork, poultry, or seafood,
                                        are cut, prepared, stored, or
                                        displayed for sale to the
                                        consumer.
                                        Produce department/
                                        operation--Areas in a retail
                                        food store where produce is cut,
                                        prepared, stored, or displayed
                                        for sale to the consumer. A
                                        produce operation may include
                                        salad bars or juice stations
                                        that are managed by the produce
                                        manager.
------------------------------------------------------------------------

    The purpose of the study is to:
     Assist FDA with developing retail food safety initiatives 
and policies focused on the control of foodborne illness risk factors;
     Identify retail food safety work plan priorities and 
allocate resources to enhance retail food safety nationwide;
     Track changes in the occurrence of foodborne illness risk 
factors in retail and foodservice establishments over time; and
     Inform recommendations to the retail and foodservice 
industry and State, local, tribal, and territorial regulatory 
professionals on reducing the occurrence of foodborne illness risk 
factors.
    The statutory basis for FDA conducting this study is derived from 
the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 
311(a)). Responsibility for carrying out the provisions of the PHS Act 
relative to food protection was transferred to the Commissioner of Food 
and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the 
Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other 
Federal, State, and local government bodies.
    The objectives of the study are to:
     Identify the foodborne illness risk factors that are in 
most need of priority attention during each data collection period;
     Track trends in the occurrence of foodborne illness risk 
factors over time;
     Examine potential correlations between operational 
characteristics of food establishments and the control of foodborne 
illness risk factors;
     Examine potential correlations between elements within 
regulatory retail food protection programs and the

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control of foodborne illness risk factors; and
     Evaluate the impact of industry food safety management 
systems in controlling the occurrence of foodborne illness risk 
factors.
    The methodology to be used for this information collection is 
described as follows. To obtain a sufficient number of observations to 
conduct statistically significant analysis, FDA will conduct 
approximately 400 data collections in each facility type. This sample 
size has been calculated to provide for sufficient observations to be 
95 percent confident that the compliance percentage is within 5 percent 
of the true compliance percentage.
    A geographical information system database containing a listing of 
businesses throughout the United States provides the establishment 
inventory for the data collections. FDA samples establishments from the 
inventory based on the descriptions in table 1. FDA does not intend to 
sample 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 intent is to sample establishments that fall under risk categories 
2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists 
(Specialists) who 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 Center 
for Food Safety and Applied Nutrition personnel in the application and 
interpretation of the FDA Food Code (Ref. 5).
    Sampling zones have been established that are equal to the 150-mile 
radius around a Specialist's home location. The sample is selected 
randomly from among all eligible establishments located within these 
sampling zones. The Specialists are generally located in major 
metropolitan areas (i.e., population centers) across the contiguous 
United States. Population centers usually contain a large concentration 
of the establishments FDA intends to sample. Sampling from the 150-mile 
radius sampling zones around the Specialists' home locations provides 
three advantages to the study:
    1. It provides a cross-section of urban and rural areas from which 
to sample the eligible establishments.
    2. It represents a mix of small, medium, and large regulatory 
entities having jurisdiction over the eligible establishments.
    3. It reduces overnight travel and therefore reduces travel costs 
incurred by the Agency to collect data.
    The sample for each data collection period is 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 have been selected for 
each Specialist for cases where the institutional foodservice, school, 
or retail food facility is misclassified, closed, or otherwise 
unavailable, unable, or unwilling to participate.
    Prior to conducting the data collection, Specialists contact the 
State or local jurisdiction that has regulatory responsibility for 
conducting retail food inspections for the selected establishment. The 
Specialist verifies with the jurisdiction that the facility has been 
properly classified for the purposes of the study and is still in 
operation. The Specialist ascertains 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 is extended to the State or local regulatory authority to 
accompany the Specialist on the data collection visit.
    A standard form is used by the Specialists during each data 
collection. 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''. The information in Section 1--
''Establishment Information'' of the form is obtained during an 
interview with the establishment owner or person in charge by the 
Specialist and includes a standard set of questions.
    The information in Section 2--''Regulatory Authority Information'' 
is obtained during an interview with the program director of the State 
or local jurisdiction that has regulatory responsibility for conducting 
inspections for the selected establishment. Section 3 includes three 
parts: Part A for tabulating the Specialists' observations of the food 
employees' behaviors and practices in limiting contamination, 
proliferation, and survival of food safety hazards; Part B for 
assessing the food safety management being implemented by the facility; 
and Part C for assessing the frequency and extent of food employee hand 
washing. The information in Part A is collected from the Specialists' 
direct observations of food employee behaviors and practices. 
Infrequent, nonstandard questions may be asked by the Specialists if 
clarification is needed on the food safety procedure or practice being 
observed. The information in Part B is collected by making direct 
observations and asking followup questions of facility management to 
obtain information on the extent to which the food establishment has 
developed and implemented food safety management systems. The 
information in Part C is collected by making direct observations of 
food employee hand washing. No questions are asked in the completion of 
Section 3, Part C of the form.
    FDA collects the following information associated with the 
establishment's identity: Establishment name, street address, city, 
state, zip code, county, industry segment, and facility type. The 
establishment identifying information is collected to ensure the data 
collections are not duplicative. Other information related to the 
nature of the operation, such as seating capacity and number of 
employees per shift, is also collected. Data will be consolidated and 
reported in a manner that does not reveal the identity of any 
establishment included in the study.
    FDA is working with the National Center for Food Protection and 
Defense to develop a Web-based platform in FoodSHIELD to collect, 
store, and analyze data for the Retail Risk Factor Study. Once 
developed, this platform will be accessible to State, local, 
territorial, and tribal regulatory jurisdictions to collect data 
relevant to their own risk factor studies. FDA is currently 
transitioning from the manual entry of data to the use of hand-held 
technology. Contingent upon the completion of the Web-based platform, 
FDA intends to pilot test the use of hand-held technology during its 
2015-2016 risk factor study data collection in institutional 
foodservice, school, and retail food store facility types, with the 
goal to have it fully implemented by the next data collection in 
restaurant facility types that will occur in 2017-2018. When a data 
collector is assigned a specific establishment, he or she conducts the 
data collection and enters the information into the Web-based data 
platform. The interface will support the manual entering of data, as 
well as the ability to upload a fillable PDF.

[[Page 64171]]

    The burden for this collection of information is as follows. For 
each data collection, the respondents includes: (1) The person in 
charge of the selected facility type (whether it be a health care 
facility, school, or supermarket/grocery store); and (2) the program 
director (or designated individual) of the respective regulatory 
authority. To provide the sufficient number of observations needed to 
conduct a statistically significant analysis of the data, FDA has 
determined that 400 data collections will be required in each of the 
three facility types. Therefore, the total number of responses will be 
2,400 (400 data collections x 3 facility types x 2 respondents per data 
collection).
    The burden associated with the completion of Sections 1 and 3 of 
the form is specific to the persons in charge of the selected 
facilities. It includes the time it will take the persons in charge to 
accompany the data collectors during the site visit and answer the data 
collectors' questions. The burden related to the completion of Section 
2 of the form is specific to the program directors (or designated 
individuals) of the respective regulatory authorities. It includes the 
time it will take to answer the data collectors' questions and is the 
same regardless of the facility type.
    To calculate the estimate of the hours per response, FDA uses the 
average data collection duration for similar facility types during 
FDA's 2008 Risk Factor Study (Ref. 3) plus an extra 30 minutes (0.5 
hours) for the information collection related to Section 3, Part B of 
the form. FDA estimates that it will take the persons in charge of 
health care facility types, schools, and retail food stores 150 minutes 
(2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours), 
respectively, to accompany the data collectors while they complete 
Sections 1 and 3 of the form. FDA estimates that it will take the 
program director (or designated individual) of the respective 
regulatory authority 30 minutes (0.5 hours) to answer the questions 
related to Section 2 of the form. The total burden estimate for a data 
collection, including both the program director's and the person in 
charge's responses, in health care facility types is 180 minutes 
(150+30)(3 hours), in schools is 150 minutes (120+30)(2.5 hours), and 
in retail food stores is 210 minutes (180+30)(3.5 hours).
    Based on the number of entry refusals from the 2013-2014 Risk 
Factor Study in the restaurant facility types, we estimate a refusal 
rate of 2 percent in the institutional foodservice and retail food 
store facility types. The estimate of the time per non-respondent is 5 
minutes (0.08 hours) for the person in charge to listen to the purpose 
of the visit and provide a verbal refusal of entry.

                                                                         Table 2--Estimated Annual Reporting Burden \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of                                       Number of
                   Activity                        Number of     responses per   Total annual   Number of non-   responses per   Total annual        Average burden per response         Total
                                                  respondents     respondent       responses      respondents   non-respondent   non-responses                                           hours
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2015-2016 Data Collection (Health Care                     400               1             400  ..............  ..............  ..............  2.5.................................       1,000
 Facilities)--Completion of Sections 1 and 3.
2015-2016 Data Collection (Schools)--                      400               1             400  ..............  ..............  ..............  2...................................         800
 Completion of Sections 1 and 3.
2015-2016 Data Collection (Retail Food                     400               1             400  ..............  ..............  ..............  3...................................       1,200
 Stores)--Completion of Sections 1 and 3.
2015-2016 Data Collection-Completion of                  1,200               1           1,200  ..............  ..............  ..............  0.5.................................         600
 Section 2--All Facility Types.
2017-2018 Data Collection-Entry Refusals--All   ..............  ..............  ..............              24               1              24  0.08 (5 minutes)....................        1.92
 Facility Types.
                                               -------------------------------------------------------------------------------------------------------------------------------------------------
    Total Hours...............................  ..............  ..............  ..............  ..............  ..............  ..............  ....................................    3,601.92
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing 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, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. ``Report of the FDA Retail Food Program Database of Foodborne 
Illness Risk Factors (2000).'' Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm123546.pdf.
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/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf.
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/FoodborneIllnessandRiskFactorReduction/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/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf.
5. ``FDA Food Code.'' Available at: http://www.fda.gov/FoodCode.

    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22438 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P