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, 15996-15999 [2024-04722]
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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
VII. Executive Order 12866 Statement
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Trenesha Fultz-Mimms, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–04674 Filed 3–5–24; 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; 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.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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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
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
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,
15997
• 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
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:
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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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
• 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.
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 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. 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 Restaurants—Completion of Sections 1 and 3 ......................
Full-Service Restaurants—Completion of Sections 1 and 3 ...................
Fast-Food and Full-Service Restaurants—Completion of Section 2 .......
Retail Food Stores—Completion of Form FDA 3967, Sections 1 and 3
Retail Food Stores—Completion of Form FDA 3967, Section 2 .............
Entry Refusals—All Facility Types ...........................................................
400
400
800
400
400
24
1
1
1
1
1
1
400
400
800
400
400
24
1.36 .............................
1.73 .............................
0.5 (30 minutes) .........
3 ..................................
0.5 (30 minutes) .........
0.08 (5 minutes) .........
544
692
400
1,200
200
2
Total ..................................................................................................
........................
........................
........................
.....................................
3,038
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. 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.
5 FDA, ‘‘FDA Food Code.’’ Available at https://
www.fda.gov/FoodCode.
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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
Dated: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Applications for FDA Approval To
Market a New Drug—21 CFR Part 314
[FR Doc. 2024–04722 Filed 3–5–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2030]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Food and Drug Administration
Approval to Market a New Drug
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 April 5,
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 0910–0001. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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:
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OMB Control Number 0910–0001—
Revision
This information collection supports
implementation of statutory and
regulatory authorities that govern new
drugs. Under section 505(a) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(a)), a new
drug may not be commercially marketed
in the United States unless an approval
of an application filed with FDA under
section 505(b) or (j) of the FD&C Act is
effective with respect to such drug. We
have issued regulations in part 314 (21
CFR part 314) that establish procedures
and requirements for applications
submitted in accordance with section
505 of the FD&C Act. The regulations in
subpart A (§§ 314.1 through 314.3) set
forth general provisions, while
regulations in subparts B and C
(§§ 314.50 through 314.99) set forth
content and format requirements for
new drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) respectively. The regulations
include requirements for the submission
of specific data elements along with
patent information, pediatric use
information, supplements and
amendments, proposed labeling, and
specific postmarketing reports (PMRs).
Respondents to the information
collection are sponsors of these
applications.
Regulations in subpart D (§§ 314.100
through 314.170) explain Agency
actions on applications and set forth
timeframes for FDA review. The
information collection includes
provisions established through our
Agency user fee programs, most recently
authorized under the FDA User Fee
Reauthorization Act of 2022. These
provisions pertain to performance goals,
expedited programs, review
transparency, communications with
FDA, dispute resolution, drug safety
enhancements, and the allocation of
Agency resources to align with these
program objectives as agreed to with our
stakeholders and set forth in our ‘‘User
Fee Performance Goals for Fiscal Years
2023–2027’’ Commitment Letters, which
are available from our website at https://
www.fda.gov along with more
information about specific FDA user fee
programs.
Included among the provisions in
subpart G (§§ 314.410 through 314.445),
§ 314.420 covers information to include
in drug master files (DMFs). To assist
respondents to this information
collection we have prepared templates,
guidance, forms, and resources available
from our website at https://
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15999
www.fda.gov/drugs/forms-submissionrequirements/drug-master-files-dmfs.
We have developed Form FDA 3938 and
accompanying instructions on
submitting DMFs in accordance with
the applicable regulations. We are
revising Form FDA 3898 and the
accompanying instructions to allow for
multiple selections of submission types
and to clarify the number of digits to be
entered for the holder and establishment
registration numbers.
In accordance with § 314.445, we also
develop Agency guidance documents to
assist respondents in complying with
provisions in part 314. These guidance
documents are issued consistent with
our good guidance practice regulations
at 21 CFR 10.115. To search available
FDA guidance documents, visit our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents.
Applications submitted in accordance
with subpart H (§§ 314.500 through
314.560) pertain to accelerated approval
of new drugs for serious or lifethreatening illnesses.
Information collection and associated
burden for the submissions in subpart I
(§§ 314.600 through 314.650) pertain to
approval of certain new drugs when
human efficacy studies are not ethical or
feasible. The regulations provide for the
submission of specific data elements,
animal studies of safety and efficacy to
establish likely clinical benefit in
humans and upon approval of the drug
product, additional requirements and/or
restrictions to ensure safe use of the
product. Additional PMRs, safety
reporting, and promotional material as
well as requirements for withdrawal of
these human drug applications, and
FDA termination of requirements for
these human drug applications are
included in §§ 314.620 through 314.650.
The estimated burden for these human
drug applications is included in the
reported submissions and burden under
general human drug applications,
§ 314.50, and other specific regulations
in the table for human drug application
requirements in general.
Finally, we are also revising the
collection to include the submission of
information pursuant to the CREATES
Act (enacted as part of the Further
Consolidated Appropriations Act of
2020 (21 U.S.C. 355–1(1) and 355–2)).
Under the CREATES Act, developers of
potential drug and biological products
are enabled to use the CREATES
pathway to obtain samples of brand
products that are needed to support
their applications. Relevant products
include those submitted in generic drug
applications under section 505(j) of the
FD&C Act and NDAs submitted under
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
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:
[[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
