Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types, 14433-14436 [2021-05325]
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
Instrument
Annual
number of
respondents
Annual number
of responses
per respondent
Average
burden hours
per response
Total/annual
burden hours
Intended Use Plan .........................................................................................
56
1
40
2,240.
acceptance receipt is on or before that
date.
Estimated Total Annual Burden
Hours: 2,240.
Authority: 42 U.S.C. 1397 through 1397e.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–05408 Filed 3–15–21; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0547]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Retail and
Foodservice Facility Types
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on ‘‘Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Retail and
Foodservice Facility Types.’’
DATES: Submit either electronic or
written comments on the collection of
information by May 17, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 17, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 17, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0547 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Survey
on the Occurrence of Foodborne Illness
Risk Factors in Selected Retail and
Foodservice Facility Types.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
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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-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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
SUPPLEMENTARY INFORMATION:
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Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Retail
and Foodservice Facility Types
OMB Control Number 0910–0744—
Extension
I. Background
From 1998 to 2008, the FDA’s
National Retail Food Team conducted a
study to measure trends in the
occurrence of foodborne illness risk
factors, preparation practices, and
employee behaviors most commonly
reported to the Centers for Disease
Control and Prevention as contributing
factors to foodborne illness outbreaks at
the retail level. Specifically, data was
collected by FDA Specialists in retail
and foodservice establishments at 5-year
intervals (1998, 2003, and 2008) in order
to observe and document trends in the
occurrence of the following foodborne
illness risk factors:
• Food from Unsafe Sources,
• Poor Personal Hygiene,
• Inadequate Cooking,
• Improper Holding/Time and
Temperature, and
• Contaminated Equipment/CrossContamination.
FDA developed reports summarizing
the findings for each of the three data
collection periods, released in 2000,
2004, and 2009 (Refs. 1 to 3). Data from
all three data collection periods were
analyzed to detect trends in
improvement or regression over time
and to determine whether progress had
been made toward the goal of reducing
the occurrence of foodborne illness risk
factors in selected retail and foodservice
facility types (Ref. 4).
Using this 10-year survey as a
foundation, in 2013–2014, FDA initiated
a new study in full-service and fast-food
restaurants. This study will span 10
years with data collections completed in
2013–2014 and 2017–2018, and an
additional collection planned for 2021–
2022. Three data collections are
necessary to trend the data. Data
collected in 2013–2014 is published,
and data from 2017–2018 is currently
being evaluated for trends and
significance.
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
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.
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Fast-Food Restaurants ........
The results of this 10-year study
period will be used to:
• Develop retail food safety
initiatives, policies, and targeted
intervention strategies focused on
controlling foodborne illness risk
factors;
• Provide technical assistance to
State, local, tribal, and territorial
regulatory professionals;
• Identify FDA retail work plan
priorities; and
• Inform FDA resource allocation to
enhance retail food safety nationwide.
The statutory basis for FDA
conducting this study is derived from
the Public Health Service Act (PHS Act)
(42 U.S.C. 243, section 311(a)).
Responsibility for carrying out the
provisions of the PHS Act relative to
food protection was transferred to the
Commissioner of Food and Drugs in
1968 (21 CFR 5.10(a)(2) and (4)).
Additionally, the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.)
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and the Economy Act (31 U.S.C. 1535)
require FDA to provide assistance to
other Federal, State, and local
government bodies.
The objectives of this study are to:
• Identify the least and most often
occurring foodborne illness risk factors
and food safety behaviors/practices in
restaurants within the United States;
• Determine the extent to which Food
Safety Management Systems and the
presence of a Certified Food Protection
Manager impact the occurrence of
foodborne illness risk factors and food
safety behaviors/practices; and
• Determine whether the occurrence
of foodborne illness risk factors food
safety behaviors/practices in delis
differs based on an establishment’s risk
categorization and status as a single-unit
or multiple-unit operation (e.g.,
restaurants that are part of an operation
with two or more units).
The methodology to be used for this
information collection is described as
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follows. To obtain a sufficient number
of observations to conduct statistically
significant analysis, FDA will conduct
approximately 400 data collections in
each facility type. This sample size has
been calculated to provide for sufficient
observations to be 95 percent confident
that the compliance percentage is
within 5 percent of the true compliance
percentage.
A geographical information system
database containing a listing of
businesses throughout the United States
provides the establishment inventory for
the data collections. FDA samples
establishments from the inventory based
on the descriptions in table 1. FDA does
not intend to sample operations that
handle only prepackaged food items or
conduct low-risk food preparation
activities. The ‘‘FDA Food Code’’
contains a grouping of establishments
by risk, based on the type of food
preparation that is normally conducted
within the operation (Ref. 5). The intent
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is to sample establishments that fall
under risk categories 2 through 4.
FDA has approximately 25 Retail
Food Specialists (Specialists) who serve
as the data collectors for the 10-year
study. The Specialists are
geographically dispersed throughout the
United States and possess technical
expertise in retail food safety and a solid
understanding of the operations within
each of the facility types to be surveyed.
The Specialists are also standardized by
FDA’s Center for Food Safety and
Applied Nutrition personnel in the
application and interpretation of the
FDA Food Code (Ref. 5).
Sampling zones have been established
that are equal to the 175-mile radius
around a Specialist’s home location.
The sample is selected randomly from
among all eligible establishments
located within these sampling zones.
The Specialists are generally located in
major metropolitan areas (i.e.,
population centers) across the
contiguous United States. Population
centers usually contain a large
concentration of the establishments
FDA intends to sample. Sampling from
the 175-mile radius sampling zones
around the Specialists’ home locations
provides three advantages to the study:
1. It provides a cross-section of urban
and rural areas from which to sample
the eligible establishments.
2. It represents a mix of small,
medium, and large regulatory entities
having jurisdiction over the eligible
establishments.
3. It reduces overnight travel and,
therefore, reduces travel costs incurred
by the Agency to collect data.
The sample for each data collection
period is evenly distributed among
Specialists. Given that participation in
the study by industry is voluntary and
the status of any given randomly
selected establishment is subject to
change, substitute establishments have
been selected for each Specialist for
cases where the restaurant facility is
misclassified, closed, or otherwise
unavailable, unable, or unwilling to
participate.
Prior to conducting the data
collection, Specialists contact the State
or local jurisdiction that has regulatory
responsibility for conducting retail food
inspections for the selected
establishment. The Specialist verifies
with the jurisdiction that the facility has
been properly classified for the
purposes of the study and is still in
operation. The Specialist ascertains
whether the selected facility is under
legal notice from the State or local
regulatory authority. If the selected
facility is under legal notice, the
Specialist will not conduct a data
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collection, and a substitute
establishment will be used. An
invitation is extended to the State or
local regulatory authority to accompany
the Specialist on the data collection
visit.
A standard form is used by the
Specialists during each data collection.
The form is divided into three sections:
Section 1—‘‘Establishment
Information’’; Section 2—‘‘Regulatory
Authority Information’’; and Section 3—
‘‘Foodborne Illness Risk Factor and
Food Safety Management System
Assessment.’’ The information in
Section 1 ‘‘Establishment Information’’
of the form is obtained during an
interview with the establishment owner
or person in charge by the Specialist
and includes a standard set of questions.
The information in Section 2
‘‘Regulatory Authority Information’’ is
obtained during an interview with the
program director of the State or local
jurisdiction that has regulatory
responsibility for conducting
inspections for the selected
establishment.
Section 3 includes three parts: Part A
for tabulating the Specialists’
observations of the food employees’
behaviors and practices in limiting
contamination, proliferation, and
survival of food safety hazards; Part B
for assessing the food safety
management system being implemented
by the facility; and Part C for assessing
the frequency and extent of food
employee handwashing. The
information in Part A is collected from
the Specialists’ direct observations of
food employee behaviors and practices.
Infrequent, nonstandard questions may
be asked by the Specialists if
clarification is needed on the food safety
procedure or practice being observed.
The information in Part B is collected by
making direct observations and asking
follow-up questions of facility
management to obtain information on
the extent to which the food
establishment has developed and
implemented food safety management
systems. The information in Part C is
collected by making direct observations
of food employee handwashing. No
questions are asked in the completion of
Section 3, Part C of the form.
FDA collects the following
information associated with the
establishment’s identity: Establishment
name, street address, city, State, ZIP
Code, county, industry segment, and
facility type. The 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
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14435
employees per shift, is also collected.
Data will be consolidated and reported
in a manner that does not reveal the
identity of any establishment included
in the study.
FDA has collaborated with the Food
Protection and Defense Institute to
develop a web-based platform in
FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor
Study. This platform is accessible to
State, local, territorial, and tribal
regulatory jurisdictions to collect data
relevant to their own risk factor studies.
For the 2015–2016 data collection, FDA
piloted the use of hand-held technology
for capturing the data onsite during the
data collection visits. The tablets that
were made available for the data
collections were part of a broader
Agency initiative focused on internal
uses of hand-held technology. The
tablets provided for the data collection
presented several technical and
logistical challenges and increased the
time burden associated with the data
collection as compared to the manual
entry of data collections. For these
reasons, FDA will not be further
evaluating hand-held technology in
subsequent data collections during the
10-year study period.
When a data collector is assigned a
specific establishment, he or she
conducts the data collection and enters
the information into the web-based data
platform. The interface will support the
manual entering of data, as well as the
ability to directly enter information in
the database via a web browser.
The burden for the 2021–2022 data
collection is as follows. For each data
collection, the respondents will include:
(1) The person in charge of the selected
facility (whether it be a fast-food or fullservice restaurant); and (2) the program
director (or designated individual) of
the respective regulatory authority. In
order to provide the sufficient number
of observations needed to conduct a
statistically significant analysis of the
data, FDA has determined that 400 data
collections will be required in each of
the two restaurant facility types.
Therefore, the total number of responses
will be 1,600 (400 data collections × 2
facility types × 2 respondents per data
collection).
The burden associated with the
completion of Sections 1 and 3 of the
form is specific to the persons in charge
of the selected facilities. The burden
includes the time it will take the person
in charge to accompany the data
collector during the site visit and
answer the data collector’s questions.
The burden related to the completion of
Section 2 of the form is specific to the
program directors (or designated
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individuals) of the respective regulatory
authorities. The burden includes the
time it will take to answer the data
collectors’ questions and is the same
regardless of the facility type.
To calculate the estimate of the hours
per response, FDA will use the average
data collection duration for the same
facility types during the 2015–2016 data
collection. FDA estimates that it will
take the persons in charge of full-service
restaurants and fast-food restaurants 104
minutes (1.73 hours) and 82 minutes
(1.36 hours), respectively, to accompany
the data collectors while they complete
Sections 1 and 3 of the form. In
comparison, for the 2017–2018 data
collection, the burden estimate was 106
minutes (1.76 hours) in full-service
restaurants and 73 minutes (1.21 hours)
in fast-food restaurants. FDA estimates
that it will take the program director (or
designated individual) of the respective
regulatory authority 30 minutes (0.5
hours) to answer the questions related to
Section 2 of the form. This burden
estimate is unchanged from the last data
collection. Hence, the total burden
estimate for a data collection in a fullservice restaurant, including both the
program director’s and the person in
charge’s responses, is 134 minutes (104
+ 30) (2.23 hours). The total burden
estimate for a data collection in a fastfood restaurant, including both the
program director’s and the person in
charge’s responses, is 112 minutes (82 +
30) (1.86 hours).
Based on the number of entry refusals
from the 2017–2018 data collection, we
estimate a refusal rate of 2 percent for
the data collections within restaurant
facility types. The estimate of the time
per non-respondent is 5 minutes (0.08
hours) for the person in charge to listen
to the purpose of the visit and provide
a verbal refusal of entry.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
2021–2022 Data Collection (Fast Food Restaurants)—Completion of Sections 1 and 3.
2021–2022 Data Collection (Full-Service Restaurants)—Completion of Sections 1 and 3.
2021–2022 Data Collection—Completion of Section 2—All Facility Types.
2021–2022 Data Collection—Entry Refusals—All
Facility Types.
Total Hours ......................................................
1 There
Total annual
responses
Number of
non-respondents
Number of
responses per
non-respondent
Total annual
non-responses
Average burden per
response
Total
hours
400
1
400
............................
..........................
..........................
1.36 ........................
544
400
1
400
............................
..........................
..........................
1.73 ........................
692
800
1
800
............................
..........................
..........................
0.5 (30 minutes) .....
400
......................
..........................
......................
16
1
16
0.08 (5 minutes) .....
1.28
......................
..........................
......................
............................
..........................
..........................
................................
1,637.28
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
II. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
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Number of
responses per
respondent
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/FoodborneIllness
RiskFactorReduction/UCM423850.pdf
3. FDA, ‘‘FDA Report on the Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice,
Restaurant, and Retail Food Store
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16:52 Mar 15, 2021
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Facility Types (2009).’’ Available at
https://wayback.archive-it.org/7993/
20170406023004/https://www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/FoodborneIllness
RiskFactorReduction/ucm224321.htm
4. FDA National Retail Food Team, ‘‘FDA
Trend Analysis Report on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice, Restaurant, and Retail Food
Store Facility Types (1998–2008).’’
(2010). Available at https://
wayback.archive-it.org/7993/
20170406022950/https://www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/FoodborneIllness
RiskFactorReduction/ucm223293.htm
5. FDA, ‘‘FDA Food Code.’’ Available at
https://www.fda.gov/FoodCode.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
SUMMARY:
[FR Doc. 2021–05325 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
[Docket No. FDA–2018–N–1857]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food, and Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Animal Food
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 the information
collection requirements associated with
current good manufacturing practice,
E:\FR\FM\16MRN1.SGM
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Agencies
[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14433-14436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05325]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0547]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey on the Occurrence of Foodborne Illness Risk
Factors in Selected Retail and Foodservice Facility Types
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Retail and Foodservice Facility
Types.''
DATES: Submit either electronic or written comments on the collection
of information by May 17, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0547 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Survey on the Occurrence of
Foodborne Illness Risk Factors in Selected Retail and Foodservice
Facility Types.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
[[Page 14434]]
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Retail and Foodservice Facility Types
OMB Control Number 0910-0744--Extension
I. Background
From 1998 to 2008, the FDA's National Retail Food Team conducted a
study to measure trends in the occurrence of foodborne illness risk
factors, preparation practices, and employee behaviors most commonly
reported to the Centers for Disease Control and Prevention as
contributing factors to foodborne illness outbreaks at the retail
level. Specifically, data was collected by FDA Specialists in retail
and foodservice establishments at 5-year intervals (1998, 2003, and
2008) in order to observe and document trends in the occurrence of the
following foodborne illness risk factors:
Food from Unsafe Sources,
Poor Personal Hygiene,
Inadequate Cooking,
Improper Holding/Time and Temperature, and
Contaminated Equipment/Cross-Contamination.
FDA developed reports summarizing the findings for each of the
three data collection periods, released in 2000, 2004, and 2009 (Refs.
1 to 3). Data from all three data collection periods were analyzed to
detect trends in improvement or regression over time and to determine
whether progress had been made toward the goal of reducing the
occurrence of foodborne illness risk factors in selected retail and
foodservice facility types (Ref. 4).
Using this 10-year survey as a foundation, in 2013-2014, FDA
initiated a new study in full-service and fast-food restaurants. This
study will span 10 years with data collections completed in 2013-2014
and 2017-2018, and an additional collection planned for 2021-2022.
Three data collections are necessary to trend the data. Data collected
in 2013-2014 is published, and data from 2017-2018 is currently being
evaluated for trends and significance.
Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
The results of this 10-year study period will be used to:
Develop retail food safety initiatives, policies, and
targeted intervention strategies focused on controlling foodborne
illness risk factors;
Provide technical assistance to State, local, tribal, and
territorial regulatory professionals;
Identify FDA retail work plan priorities; and
Inform FDA resource allocation to enhance retail food
safety nationwide.
The statutory basis for FDA conducting this study is derived from
the Public Health Service Act (PHS Act) (42 U.S.C. 243, section
311(a)). Responsibility for carrying out the provisions of the PHS Act
relative to food protection was transferred to the Commissioner of Food
and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the
Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other
Federal, State, and local government bodies.
The objectives of this study are to:
Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in restaurants
within the United States;
Determine the extent to which Food Safety Management
Systems and the presence of a Certified Food Protection Manager impact
the occurrence of foodborne illness risk factors and food safety
behaviors/practices; and
Determine whether the occurrence of foodborne illness risk
factors food safety behaviors/practices in delis differs based on an
establishment's risk categorization and status as a single-unit or
multiple-unit operation (e.g., restaurants that are part of an
operation with two or more units).
The methodology to be used for this information collection is
described as follows. To obtain a sufficient number of observations to
conduct statistically significant analysis, FDA will conduct
approximately 400 data collections in each facility type. This sample
size has been calculated to provide for sufficient observations to be
95 percent confident that the compliance percentage is within 5 percent
of the true compliance percentage.
A geographical information system database containing a listing of
businesses throughout the United States provides the establishment
inventory for the data collections. FDA samples establishments from the
inventory based on the descriptions in table 1. FDA does not intend to
sample operations that handle only prepackaged food items or conduct
low-risk food preparation activities. The ``FDA Food Code'' contains a
grouping of establishments by risk, based on the type of food
preparation that is normally conducted within the operation (Ref. 5).
The intent
[[Page 14435]]
is to sample establishments that fall under risk categories 2 through
4.
FDA has approximately 25 Retail Food Specialists (Specialists) who
serve as the data collectors for the 10-year study. The Specialists are
geographically dispersed throughout the United States and possess
technical expertise in retail food safety and a solid understanding of
the operations within each of the facility types to be surveyed. The
Specialists are also standardized by FDA's Center for Food Safety and
Applied Nutrition personnel in the application and interpretation of
the FDA Food Code (Ref. 5).
Sampling zones have been established that are equal to the 175-mile
radius around a Specialist's home location. The sample is selected
randomly from among all eligible establishments located within these
sampling zones. The Specialists are generally located in major
metropolitan areas (i.e., population centers) across the contiguous
United States. Population centers usually contain a large concentration
of the establishments FDA intends to sample. Sampling from the 175-mile
radius sampling zones around the Specialists' home locations provides
three advantages to the study:
1. It provides a cross-section of urban and rural areas from which
to sample the eligible establishments.
2. It represents a mix of small, medium, and large regulatory
entities having jurisdiction over the eligible establishments.
3. It reduces overnight travel and, therefore, reduces travel costs
incurred by the Agency to collect data.
The sample for each data collection period is evenly distributed
among Specialists. Given that participation in the study by industry is
voluntary and the status of any given randomly selected establishment
is subject to change, substitute establishments have been selected for
each Specialist for cases where the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
Prior to conducting the data collection, Specialists contact the
State or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist verifies with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist ascertains whether the selected facility is
under legal notice from the State or local regulatory authority. If the
selected facility is under legal notice, the Specialist will not
conduct a data collection, and a substitute establishment will be used.
An invitation is extended to the State or local regulatory authority to
accompany the Specialist on the data collection visit.
A standard form is used by the Specialists during each data
collection. The form is divided into three sections: Section 1--
``Establishment Information''; Section 2--``Regulatory Authority
Information''; and Section 3--``Foodborne Illness Risk Factor and Food
Safety Management System Assessment.'' The information in Section 1
``Establishment Information'' of the form is obtained during an
interview with the establishment owner or person in charge by the
Specialist and includes a standard set of questions.
The information in Section 2 ``Regulatory Authority Information''
is obtained during an interview with the program director of the State
or local jurisdiction that has regulatory responsibility for conducting
inspections for the selected establishment.
Section 3 includes three parts: Part A for tabulating the
Specialists' observations of the food employees' behaviors and
practices in limiting contamination, proliferation, and survival of
food safety hazards; Part B for assessing the food safety management
system being implemented by the facility; and Part C for assessing the
frequency and extent of food employee handwashing. The information in
Part A is collected from the Specialists' direct observations of food
employee behaviors and practices. Infrequent, nonstandard questions may
be asked by the Specialists if clarification is needed on the food
safety procedure or practice being observed. The information in Part B
is collected by making direct observations and asking follow-up
questions of facility management to obtain information on the extent to
which the food establishment has developed and implemented food safety
management systems. The information in Part C is collected by making
direct observations of food employee handwashing. No questions are
asked in the completion of Section 3, Part C of the form.
FDA collects the following information associated with the
establishment's identity: Establishment name, street address, city,
State, ZIP Code, county, industry segment, and facility type. The
establishment-identifying information is collected to ensure the data
collections are not duplicative. Other information related to the
nature of the operation, such as seating capacity and number of
employees per shift, is also collected. Data will be consolidated and
reported in a manner that does not reveal the identity of any
establishment included in the study.
FDA has collaborated with the Food Protection and Defense Institute
to develop a web-based platform in FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor Study. This platform is
accessible to State, local, territorial, and tribal regulatory
jurisdictions to collect data relevant to their own risk factor
studies. For the 2015-2016 data collection, FDA piloted the use of
hand-held technology for capturing the data onsite during the data
collection visits. The tablets that were made available for the data
collections were part of a broader Agency initiative focused on
internal uses of hand-held technology. The tablets provided for the
data collection presented several technical and logistical challenges
and increased the time burden associated with the data collection as
compared to the manual entry of data collections. For these reasons,
FDA will not be further evaluating hand-held technology in subsequent
data collections during the 10-year study period.
When a data collector is assigned a specific establishment, he or
she conducts the data collection and enters the information into the
web-based data platform. The interface will support the manual entering
of data, as well as the ability to directly enter information in the
database via a web browser.
The burden for the 2021-2022 data collection is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected facility (whether it be a fast-food or full-
service restaurant); and (2) the program director (or designated
individual) of the respective regulatory authority. In order to provide
the sufficient number of observations needed to conduct a statistically
significant analysis of the data, FDA has determined that 400 data
collections will be required in each of the two restaurant facility
types. Therefore, the total number of responses will be 1,600 (400 data
collections x 2 facility types x 2 respondents per data collection).
The burden associated with the completion of Sections 1 and 3 of
the form is specific to the persons in charge of the selected
facilities. The burden includes the time it will take the person in
charge to accompany the data collector during the site visit and answer
the data collector's questions. The burden related to the completion of
Section 2 of the form is specific to the program directors (or
designated
[[Page 14436]]
individuals) of the respective regulatory authorities. The burden
includes the time it will take to answer the data collectors' questions
and is the same regardless of the facility type.
To calculate the estimate of the hours per response, FDA will use
the average data collection duration for the same facility types during
the 2015-2016 data collection. FDA estimates that it will take the
persons in charge of full-service restaurants and fast-food restaurants
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to
accompany the data collectors while they complete Sections 1 and 3 of
the form. In comparison, for the 2017-2018 data collection, the burden
estimate was 106 minutes (1.76 hours) in full-service restaurants and
73 minutes (1.21 hours) in fast-food restaurants. FDA estimates that it
will take the program director (or designated individual) of the
respective regulatory authority 30 minutes (0.5 hours) to answer the
questions related to Section 2 of the form. This burden estimate is
unchanged from the last data collection. Hence, the total burden
estimate for a data collection in a full-service restaurant, including
both the program director's and the person in charge's responses, is
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a
data collection in a fast-food restaurant, including both the program
director's and the person in charge's responses, is 112 minutes (82 +
30) (1.86 hours).
Based on the number of entry refusals from the 2017-2018 data
collection, we estimate a refusal rate of 2 percent for the data
collections within restaurant facility types. The estimate of the time
per non-respondent is 5 minutes (0.08 hours) for the person in charge
to listen to the purpose of the visit and provide a verbal refusal of
entry.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
Activity Number of responses per Total annual Number of non- responses per Total annual Average burden per response Total
respondents respondent responses respondents non-respondent non-responses hours
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2021-2022 Data Collection (Fast Food 400 1 400 ................ ............... ............... 1.36................................ 544
Restaurants)--Completion of Sections 1 and 3.
2021-2022 Data Collection (Full-Service 400 1 400 ................ ............... ............... 1.73................................ 692
Restaurants)--Completion of Sections 1 and 3.
2021-2022 Data Collection--Completion of 800 1 800 ................ ............... ............... 0.5 (30 minutes).................... 400
Section 2--All Facility Types.
2021-2022 Data Collection--Entry Refusals--All ............ ............... ............ 16 1 16 0.08 (5 minutes).................... 1.28
Facility Types.
-------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours............................... ............ ............... ............ ................ ............... ............... .................................... 1,637.28
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
II. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. FDA, ``Report of the FDA Retail Food Program Database of
Foodborne Illness Risk Factors (2000).'' Available at https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf
2. FDA, ``FDA Report on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2004).'' Available at https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf
3. FDA, ``FDA Report on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2009).'' Available at https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm
4. FDA National Retail Food Team, ``FDA Trend Analysis Report on the
Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and Retail Food Store
Facility Types (1998-2008).'' (2010). Available at https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm
5. FDA, ``FDA Food Code.'' Available at https://www.fda.gov/FoodCode.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05325 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P