[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 15996-15999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0021]


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

DATES: Either electronic or written comments on the collection of 
information must be submitted by May 6, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 6, 2024. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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-2024-N-0021 for ``Survey on the Occurrence of Foodborne Illness 
Risk Factors in Selected Restaurant and Retail 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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

[[Page 15997]]

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 
Restaurant and Retail Foodservice Facility Types

OMB Control Number 0910-0744--Revision

    This information collection supports food safety projects 
administered by FDA. 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 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 
2009.1 2 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.\4\
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    \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).'' Available at https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
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    Using this 10-year survey as a foundation, FDA initiated a new 
study in full-service and fast-food restaurants. This study will 
include data collections completed in 2013-2014 and 2017-2018. An 
additional collection planned for 2021-2022 was halted due to the 
COVID-19 pandemic; however, an additional data collection is planned 
for 2023-2025 (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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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.
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 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 objectives of this study are to:

[[Page 15998]]

     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).
    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.\5\ The 
intent is to sample establishments that fall under risk categories 2 
through 4.
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    \5\ FDA, ``FDA Food Code.'' Available at https://www.fda.gov/FoodCode.
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    FDA has approximately 25 Retail Food Specialists (Specialists) who 
serve as the data collectors for the study. 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 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 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.
    The burden associated with the completion of Sections 1 and 3 of 
Form FDA 3967 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. 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. Data will be consolidated and reported in a manner that does 
not reveal the identity of any establishment included in the study. FDA 
estimates the burden of this collection of information as follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
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Fast-Food Restaurants--Completion of Sections             400               1             400  1.36.....................................             544
 1 and 3.
Full-Service Restaurants--Completion of                   400               1             400  1.73.....................................             692
 Sections 1 and 3.
Fast-Food and Full-Service Restaurants--                  800               1             800  0.5 (30 minutes).........................             400
 Completion of Section 2.
Retail Food Stores--Completion of Form FDA                400               1             400  3........................................           1,200
 3967, Sections 1 and 3.
Retail Food Stores--Completion of Form FDA                400               1             400  0.5 (30 minutes).........................             200
 3967, Section 2.
Entry Refusals--All Facility Types...........              24               1              24  0.08 (5 minutes).........................               2
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    Total....................................  ..............  ..............  ..............  .........................................           3,038
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\1\ There are no capital costs of 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 adjustments to our burden 
estimate. On our own initiative, however, and for efficiency of Agency 
operations, we are revising the information collection to include and 
consolidate related information collection found in 0910-0799. 
Therefore, our estimated burden for the information collection reflects 
an increase of 1,401 total burden hours and a corresponding increase of 
808 total annual responses.


[[Page 15999]]


    Dated: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04722 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P