[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10087-10091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0270]


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

DATES: Submit either electronic or written comments on the collection 
of information by April 19, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 19, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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.''

[[Page 10088]]

    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-0270 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, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected 
Institutional Foodservice and Retail Food Stores Facility Types

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 were collected by FDA Specialists in retail 
and foodservice establishments at 5-year intervals (1998, 2003, and 
2008) 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, which were released in 2000, 2004, and 
2009 (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 to 2014, FDA 
initiated a new study period. This study will span 10 years. FDA 
completed the baseline data collection in select healthcare, schools, 
and retail food store facility types in 2015 to 2016, and these data 
are being evaluated for trends and significance. A second data 
collection began in 2019 to 2020 and will be completed if it is safe to 
do so (pending COVID-19 pandemic), and an additional data collection is 
planned for 2023 to 2024 (the subject of this information collection 
request extension). Three data collections are necessary to trend the 
data.

    Table 1--Description of the Facility Types Included in the Survey
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        Facility type                         Description
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Healthcare Facilities........     Hospitals and long-term care
                                   facilities foodservice operations
                                   that prepare meals for highly
                                   susceptible populations as defined as
                                   follows:

[[Page 10089]]

 
                                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,
                                healthcare facilities that do not
                                prepare or serve food to a highly
                                susceptible population, such as mental
                                healthcare 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 onsite 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:
                                   Seafood department/operation--
                                   Areas in a retail food store where
                                   seafood is cut, prepared, stored, or
                                   displayed for sale to the consumer.
                                   In retail food stores where the
                                   seafood department is combined with
                                   another department (e.g., meat), the
                                   data collector will only assess the
                                   procedures and practices associated
                                   with the processing of seafood.
                                   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 results of this 10-year study period will be used to:
     Develop retail food safety initiatives, policies, and 
targeted intervention strategies focused on controlling foodborne 
illness risk factors;
     provide technical assistance to State, local, tribal, and 
territorial regulatory professionals;
     identify FDA retail work plan priorities; and
     inform FDA resource allocation to enhance retail food 
safety nationwide.
    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 this study are to:
     Identify the least and most often occurring foodborne 
illness risk factors and food safety behaviors/practices in select 
retail food establishments within the United States.
     determine the extent to which food safety management 
systems and the presence of a certified food protection manager impact 
the occurrence of foodborne illness risk factors and food safety 
behaviors/practices; and
     determine whether the occurrence of foodborne illness risk 
factors food safety behaviors/practices in delis differs based on an 
establishment's risk categorization and status as a single-unit or 
multiple-unit operation (e.g., establishments that are part of an 
operation with two or more units).
    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 175-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 175-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.

[[Page 10090]]

    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 store 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 system 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 has collaborated with the Food Protection and Defense Institute 
to develop a web-based platform in FoodSHIELD to collect, store, and 
analyze data for the Retail Risk Factor Study. This platform is 
accessible to State, local, territorial, and tribal regulatory 
jurisdictions to collect data relevant to their own risk factor 
studies. For the 2015 to 2016 data collection, FDA piloted the use of 
hand-held technology for capturing the data onsite during the data 
collection visits. The tablets that were made available for the data 
collections were part of a broader FDA initiative focused on internal 
uses of hand-held technology. The tablets provided for the data 
collection presented several technical and logistical challenges and 
increased the time burden associated with the data collection as 
compared to the manual entry of data collections. For these reasons FDA 
will not be incorporating use of hand-held technology in subsequent 
data collections during the 10-year study period.
    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 directly enter information in the 
database via a web browser.
    The burden for the 2023 to 2024 data collection is as follows. For 
each data collection, the respondents will include: (1) The person in 
charge of the selected facility (whether it be a healthcare 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. The burden includes the time it will take the person in 
charge to accompany the data collector during the site visit and answer 
the data collector's 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. This 
burden 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 the 
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes 
(0.5 hours) for the information related to Section 3, Part B of the 
form. FDA estimates that it will take the persons in charge of 
healthcare 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. This burden estimate is unchanged 
from the last data collection. Hence, the total burden estimate for a 
data collection in healthcare facility types is 180 minutes (150 + 30) 
(3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and retail 
food stores is 210 minutes (180 + 30) (3.5 hours).
    Based on the number of entry refusals from the 2015 to 2016 
baseline data collection, we estimate a refusal rate of 2 percent for 
the data collections within healthcare, school, 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

[[Page 10091]]

to the purpose of the visit and provide a verbal refusal of entry.
    FDA estimates the burden of this collection of information as 
follows:

                                                                         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
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2023-2024 Data Collection (Healthcare                    400                1           400  ................  ...............  ...............  2.5.................................      1,000
 Facilities)--Completion of Sections 1 and 3.
2023-2024 Data Collection (Schools)--                    400                1           400  ................  ...............  ...............  2...................................        800
 Completion of Sections 1 and 3.
2023-2024 Data Collection (Retail Food                   400                1           400  ................  ...............  ...............  3...................................      1,200
 Stores)--Completion of Sections 1 and 3.
2023-2024 Data Collection-Completion of                1,200                1         1,200  ................  ...............  ...............  0.5 (30 minutes)....................        600
 Section 2--All Facility Types.
2023-2024 Data Collection-Entry Refusals--All   ............  ...............  ............                24                1               24  0.08 (5 minutes)....................       1.92
 Facility Types.
                                               -------------------------------------------------------------------------------------------------------------------------------------------------
    Total.....................................      3,601.92  ...............  ............  ................  ...............  ...............  ....................................  .........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

II. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. ``Report of the FDA Retail Food Program Database of Foodborne 
Illness Risk Factors (2000).'' Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/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: https://wayback.archive-it.org/7993/20170406023011/https://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: https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm.
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).'' (2010). Available at: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
5. ``FDA Food Code.'' Available at: https://www.fda.gov/food/retail-food-protection/fda-food-code.

    Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03248 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P