[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14433-14436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0547]


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

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 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 May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 17, 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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0547 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Survey on the Occurrence of 
Foodborne Illness Risk Factors in Selected Retail and Foodservice 
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, 
PRAStaff@fda.hhs.gov.

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

[[Page 14434]]

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 
Retail and Foodservice Facility Types

OMB Control Number 0910-0744--Extension

I. Background

    From 1998 to 2008, the 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, 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 2013-2014, FDA 
initiated a new study in full-service and fast-food restaurants. This 
study will span 10 years with data collections completed in 2013-2014 
and 2017-2018, and an additional collection planned for 2021-2022. 
Three data collections are necessary to trend the data. Data collected 
in 2013-2014 is published, and data from 2017-2018 is currently being 
evaluated for trends and significance.

    Table 1--Description of the Facility Types Included in the Survey
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        Facility type                         Description
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Full-Service Restaurants.....  A restaurant where customers place their
                                orders at their tables, are served their
                                meals at the tables, receive the
                                services of the wait staff, and pay at
                                the end of the meals.
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.
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    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 restaurants 
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., restaurants 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

[[Page 14435]]

is to sample establishments that fall under risk categories 2 through 
4.
    FDA has approximately 25 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.
    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 restaurant 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 handwashing. 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 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 is collected by making 
direct observations of food employee handwashing. 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 2015-2016 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 Agency 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 further evaluating 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 2021-2022 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 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 400 data 
collections will be required in each of the two restaurant facility 
types. Therefore, the total number of responses 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 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

[[Page 14436]]

individuals) of the respective regulatory authorities. The 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 will use 
the average data collection duration for the same facility types during 
the 2015-2016 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), respectively, to 
accompany the data collectors while they complete Sections 1 and 3 of 
the form. In comparison, for the 2017-2018 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).
    Based on the number of entry refusals from the 2017-2018 data 
collection, we estimate a refusal rate of 2 percent for the data 
collections within restaurant 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                                         Table 2--Estimated Annual Reporting Burden \1\
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                                                                 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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2021-2022 Data Collection (Fast Food                     400                1           400  ................  ...............  ...............  1.36................................        544
 Restaurants)--Completion of Sections 1 and 3.
2021-2022 Data Collection (Full-Service                  400                1           400  ................  ...............  ...............  1.73................................        692
 Restaurants)--Completion of Sections 1 and 3.
2021-2022 Data Collection--Completion of                 800                1           800  ................  ...............  ...............  0.5 (30 minutes)....................        400
 Section 2--All Facility Types.
2021-2022 Data Collection--Entry Refusals--All  ............  ...............  ............                16                1               16  0.08 (5 minutes)....................       1.28
 Facility Types.
                                               -------------------------------------------------------------------------------------------------------------------------------------------------
    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.

    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. FDA, ``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, ``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, ``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, ``FDA Food Code.'' Available at https://www.fda.gov/FoodCode.

    Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05325 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


