Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types, 70652-70654 [2024-19574]
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70652
Federal Register / Vol. 89, No. 169 / Friday, August 30, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
William Parham at (410) 786–4669.
[Document Identifier: CMS–10650]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by September 30,
2024.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
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ADDRESSES:
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Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
Type of Information Collection
Request: Extension without change of a
previously approved collection; Title of
Information Collection: State
Permissions for Enrollment in Qualified
Health Plans in the Federally-Facilitated
Exchange & Non-Exchange Entities; Use:
On March 23, 2010, the Patient
Protection and Affordable Care Act
(PPACA; Pub. L. 111–148) was signed
into law and on March 30, 2010, the
Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152) was signed into law. The two laws
implement various health insurance
policies. This Information Collection
Request (ICR) serves as the renewal of
the data collection clearance related to
the ability of states to permit agents and
brokers, as well as web-brokers, to assist
qualified individuals, qualified
employers, or qualified employees
enrolling in Qualified Health Plans in
the Federally Facilitated Exchange (45
CFR 155.220) and data collection
requirements related to non-exchange
entities. (45 CFR 155.260). Form
Number: CMS–10650 (OMB control
number: 0938–1349); Frequency:
Annually; Affected Public: Private
Sector, State, Business, and Not-for
Profits; Number of Respondents: 93,684;
Number of Responses: 93,684; Total
Annual Hours: 473,440. (For questions
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regarding this collection, contact
Michele Oshman at (410–786–4396).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–19558 Filed 8–29–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0021]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Restaurant and
Retail Foodservice Facility Types
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by September
30, 2024.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0744. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\30AUN1.SGM
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Federal Register / Vol. 89, No. 169 / Friday, August 30, 2024 / Notices
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/CrossContamination.
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
70653
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
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
Facility type
Description
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.
A restaurant that is not a full-service restaurant. This includes restaurants commonly referred to as quick-service
restaurants and fast, casual restaurants.
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.
Fast-Food Restaurants ........
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Retail Food Stores ...............
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:
• 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
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/FoodborneIllnessRisk
FactorReduction/ucm223293.htm.
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70654
Federal Register / Vol. 89, No. 169 / Friday, August 30, 2024 / Notices
within the operation.5 The intent 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 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
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 establishmentidentifying 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.
In the Federal Register of March 6,
2024 (89 FR 15996), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received. It was in favor of the study,
but it was not responsive to the four
collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden per
response
Total
hours
Fast-Food and Full-Service Restaurants—Form FDA
3966.
Retail Food Stores—Form FDA 3967 .........................
Entry Refusals—All Facility Types ..............................
400
1
400
2 .............................
800
400
24
1
1
400
24
2 .............................
0.08 (5 minutes) .....
800
2
Total ......................................................................
........................
........................
........................
................................
1,602
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
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. Since the publication of the 60day notice, we made adjustments to our
burden estimate. Our estimated burden
for the information collection reflects a
decrease of 35 total burden hours and a
corresponding decrease of 792 total
annual responses.
Dated: August 27, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19574 Filed 8–29–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2024–0740]
Policy Letter for the Application of
Fishing Vessel Construction
Requirements
Coast Guard, DHS.
Notice of availability.
AGENCY:
ACTION:
5 FDA, ‘‘FDA Food Code.’’ Available at https://
www.fda.gov/FoodCode.
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]]>Agencies
[Federal Register Volume 89, Number 169 (Friday, August 30, 2024)]
[Notices]
[Pages 70652-70654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19574]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0021]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and
Retail Foodservice Facility Types
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 30, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0744. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 70653]]
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
------------------------------------------------------------------------
Facility type Description
------------------------------------------------------------------------
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:
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
[[Page 70654]]
within the operation.\5\ The intent is to sample establishments that
fall under risk categories 2 through 4.
---------------------------------------------------------------------------
\5\ FDA, ``FDA Food Code.'' Available at https://www.fda.gov/FoodCode.
---------------------------------------------------------------------------
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 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.
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.
In the Federal Register of March 6, 2024 (89 FR 15996), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received. It was in favor of
the study, but it was not responsive to the four collection of
information topics solicited.
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 and Full-Service Restaurants--Form 400 1 400 2........................................ 800
FDA 3966.
Retail Food Stores--Form FDA 3967............ 400 1 400 2........................................ 800
Entry Refusals--All Facility Types........... 24 1 24 0.08 (5 minutes)......................... 2
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Total.................................... .............. .............. .............. ......................................... 1,602
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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. Since
the publication of the 60-day notice, we made adjustments to our burden
estimate. Our estimated burden for the information collection reflects
a decrease of 35 total burden hours and a corresponding decrease of 792
total annual responses.
Dated: August 27, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19574 Filed 8-29-24; 8:45 am]
BILLING CODE 4164-01-P
