
[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43096-43099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2076]


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 Restaurant 
Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
20, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received,

[[Page 43097]]

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 0910-0744. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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 
Restaurant Facility Types (2013-2022)

    OMB Control Number 0910-0744

I. Background

    In 2013-2014, the U.S. Food and Drug Administration (FDA) initiated 
a study in two foodservice facility types: Full service and fast food 
restaurants. The study will span 10 years in its entirety and aims to:
     Assist FDA with developing retail food safety initiatives 
and policies focused on the control 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. (i.e. food from 
unsafe sources, poor personal hygiene, inadequate cooking, improper 
holding time and temperature, and contaminated equipment/cross-
contamination);
     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.

    Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
            Facility type                         Description
------------------------------------------------------------------------
Full Service Restaurants.............  A restaurant 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.
Fast Food Restaurants................  A restaurant that is not a full
                                        service restaurant. This
                                        includes restaurants commonly
                                        referred to as quick service
                                        restaurants and fast casual
                                        restaurants.
------------------------------------------------------------------------

    The statutory basis for FDA conducting this study is derived from 
the Public Health Service Act (42 U.S.C. 243, section 311(a)). 
Responsibility for carrying out the provisions of the 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 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 data from the 2013-2014 information collection in restaurants 
is currently being analyzed by FDA. A report summarizing the findings 
is expected to be released in 2015. In order to analyze trends, FDA is 
proposing to conduct two additional data collections in 2017-2018 and 
2021-2022 using the same methodology employed in the 2013-2014 data 
collection. This methodology is described as follows.
    In order to obtain a sufficient number of observations to conduct 
statistically significant analysis, FDA will conduct approximately 400 
data collections in each restaurant facility type during each data 
collection period. 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 will be used as the 
establishment inventory for the data collections. FDA will sample 
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. 1). The intent is to sample establishments that fall 
under 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 
Center for Food Safety and Applied Nutrition personnel in the 
application and interpretation of the FDA Food Code (Ref. 1).
    Sampling zones will be established which are equal to the 150 mile 
radius around a Specialist's home location. The sample will be 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.

[[Page 43098]]

    3. It reduces overnight travel and therefore reduces travel costs 
incurred by the Agency to collect data.
    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 where 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 form will be 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'' will be obtained during an interview with 
the establishment owner or person in charge by the Specialist and will 
include a standard set of questions.
    The information in Section 2--``Regulatory Authority Information'' 
will be 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 will be 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 will be collected by 
making direct observations and asking follow up 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 will be collected by making direct 
observations of food employee hand washing. No questions will be asked 
in the completion of Section 3, Part C of the form.
    FDA will collect 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 survey 
is not duplicative. 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, will also be 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. FDA will be pilot testing the use of hand-held technology 
during its 2015-2016 risk factor study data collection in institutional 
foodservice and retail food stores, with the goal to have it fully 
implemented for the 2017-2018 data collection in restaurants. When a 
data collector is assigned a specific establishment, he or she will 
conduct the data collection and enter 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.
    In the Federal Register of December 11, 2014 (79 FR 73596), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment; however, this 
comment did not address the information collection.
    The burden for the 2017-2018 data collection is as follows. For 
each data collection, the respondents will include: (1) The person in 
charge of the selected restaurant facility (whether it be a fast food 
or full service restaurant); and (2) the program director (or 
designated individual) of the respective regulatory authority. In order 
to provide the sufficient number of observations needed to conduct a 
statistically significant analysis of the data, FDA has determined that 
the same number of data collections will be required in each of the two 
restaurant facility types as was required in the 2013-2014 data 
collection (i.e. 400). Therefore, the total number of responses for 
restaurants will be 1,600 (400 data collections x 2 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 person in charge of the selected 
facilities. It includes the time it will take the person in charge to 
accompany the data collector as he or she completes Sections 1 and 3 of 
the form. 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 will use 
the average data collection duration for the same facility types during 
the 2013-2014 data collection. FDA estimates that it will take the 
persons in charge of full service restaurants and fast food restaurants 
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectfully, to 
accompany the data collectors while they complete Sections 1 and 3 of 
the form. In comparison, for the 2013-2014 data collection, the burden 
estimate was 106 minutes (1.76 hours) in full service restaurants and 
73 minutes (1.21 hours) in fast food restaurants. 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. This burden estimate is 
unchanged from the last data collection. Hence, the total burden 
estimate for a data collection in a full service restaurant, including 
both the program director's and the person in charge's responses, is 
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a 
data collection in a fast food restaurant, including both the program 
director's and the person in charge's responses, is 112 minutes 82 + 30 
(1.86 hours).

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    Based on the number of entry refusals from the 2013-2014 data 
collection, we estimate a refusal rate of 2 percent. The estimate of 
the time per non-respondent is five 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
                                                   Number of    responses      Total      Number of    responses      Total       Average
                    Activity                      respondents      per         annual        non-       per non-   annual non-   burden per  Total hours
                                                                respondent   responses   respondents   respondent   responses     response
--------------------------------------------------------------------------------------------------------------------------------------------------------
2017-2018 Data Collection (Fast Food                      400            1          400  ...........  ...........  ...........         1.36          544
 Restaurants)--Completion of Sections 1 and 3...
2017-2018 Data Collection (Full Service                   400            1          400  ...........  ...........  ...........         1.73          692
 Restaurants)--Completion of Sections 1 and 3...
2017-2018 Data Collection-Completion of Section           800            1          800  ...........  ...........  ...........          0.5          400
 2--All Facility Types..........................                                                                                        (30
                                                                                                                                   minutes)
2017-2018 Data Collection-Entry Refusals--All     ...........  ...........  ...........           16            1           16         0.08         1.28
 Facility Types.................................                                                                                (5 minutes)
                                                 -------------------------------------------------------------------------------------------------------
    Total Hours.................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........     1,637.28
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov.

1. FDA Food Code available at http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.


    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17809 Filed 7-20-15; 8:45 am]
 BILLING CODE 4164-01-P


