Notice2024-04722
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
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Published
March 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
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<title>Federal Register, Volume 89 Issue 45 (Wednesday, March 6, 2024)</title>
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[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 15996-15999]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="09595b485a7d686f6f496f6d682761617a276e667f">[email protected]</span></a>.
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:
<bullet> Food from Unsafe Sources,
<bullet> Poor Personal Hygiene,
<bullet> Inadequate Cooking,
<bullet> Improper Holding/Time and Temperature, and
<bullet> Contaminated Equipment/Cross-Contamination.
FDA developed reports summarizing the findings for each of the
three data collection periods, released in 2000, 2004, and
2009.<SUP>1 2 3</SUP> 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 <a href="https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf">https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf</a>.
\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 <a href="https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf">https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf</a>.
\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 <a href="https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm">https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm</a>.
\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 <a href="https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm">https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm</a>.
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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:
<bullet> 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:
<bullet> Salad bars, pizza stations,
and other food bars managed by the
deli department manager.
<bullet> 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:
<bullet> 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.
<bullet> 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.
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The results of this study period will be used to:
<bullet> Develop retail food safety initiatives, policies, and
targeted intervention strategies focused on controlling foodborne
illness risk factors;
<bullet> Provide technical assistance to State, local, tribal, and
territorial regulatory professionals;
<bullet> Identify FDA retail work plan priorities; and
<bullet> Inform FDA resource allocation to enhance retail food
safety nationwide.
The objectives of this study are to:
[[Page 15998]]
<bullet> Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in restaurants
within the United States;
<bullet> 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
<bullet> 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 <a href="https://www.fda.gov/FoodCode">https://www.fda.gov/FoodCode</a>.
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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
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