Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types, 42845-42849 [2021-16700]
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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Devices.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products or from the
Center for Biologics Evaluation and
Research at https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. This
guidance document is also available at
https://www.regulations.gov and https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Remanufacturing of
Medical Devices’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 17048 and complete title to
identify the guidance you are
requesting.
Dated: July 30, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
7, 2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0799. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
intervals (1998, 2003, and 2008) 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, which were 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 to 2014, FDA
initiated a new study period. This study
will span 10 years. FDA completed the
baseline data collection in select
healthcare, schools, and retail food store
facility types in 2015 to 2016, and these
data are being evaluated for trends and
significance. A second data collection
began in 2019 to 2020 and will be
completed if it is safe to do so (pending
COVID–19 pandemic), and an
additional data collection is planned for
2023 to 2024 (the subject of this
information collection request
extension). Three data collections are
necessary to trend the data.
OMB Control Number 0910–0799—
Extension
Food and Drug Administration
[Docket No. FDA–2018–N–0270]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice and Retail Food Stores
Facility Types
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Notice.
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types
[FR Doc. 2021–16695 Filed 8–4–21; 8:45 am]
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
ACTION:
42845
I. Background
From 1998 to 2008, 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 were collected
by FDA Specialists in retail and
foodservice establishments at 5-year
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
Facility type
Description
Healthcare Facilities ........................
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Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible
populations as defined as follows:
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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY—Continued
Facility type
Description
Schools (K–12) ...............................
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Retail Food Stores ..........................
• Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing
meals and transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals
in the cafeteria may also be served to hospital staff and visitors).
• Long-term care facilities—A foodservice operation that prepares meals for the residents in a group
care living setting such as nursing homes and assisted living facilities.
Note: For the purposes of this study, healthcare facilities that do not prepare or serve food to a highly susceptible population, such as mental healthcare facilities, are not included in this facility type category.
Foodservice operations that have the primary function of preparing and serving meals for students in one
or more grade levels from kindergarten through grade 12. A school foodservice may be part of a public
or private institution.
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 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
select retail food establishments 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
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foodborne illness risk factors and food
safety behaviors/practices; and
• determine whether the occurrence
of foodborne illness risk factors and
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.,
establishments 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
is to sample establishments that fall
under risk categories 2 through 4.
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FDA has approximately 23 Regional
Retail Food Specialists (Specialists) who
serve as the data collectors for the 10year 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.
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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 institutional
foodservice, school, or retail food store
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—‘‘Foodborne
Illness Risk Factor and Food Safety
Management System Assessment’’
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
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for assessing the frequency and extent of
food employee hand washing. 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 hand washing. 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 to 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
FDA 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 incorporating
use of 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
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42847
manual entering of data, as well as the
ability to directly enter information in
the database via a web browser.
The burden for the 2023 to 2024 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 healthcare
facility, school, or supermarket/grocery
store); and (2) the program director (or
designated individual) of the respective
regulatory authority. 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 three
facility types. Therefore, the total
number of responses will be 2,400 (400
data collections × 3 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
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.
In the Federal Register of February
18, 2021 (86 FR 10087), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment.
(Comment) An interested citizen
submitted the following comment:
a. The previous 10-year study
conducted by FDA did not mention
negative trends in the ‘‘other’’ category,
which included information about
contamination risk factors as they relate
to food or color additives, poisonous or
toxic materials, or storage of poisonous
or toxic materials for retail sale. This
negative trend should be reported.
b. In the 2013 to 2014 report on
restaurants the ‘‘other’’ contamination
risk factor did not appear in the report.
This should remain the same as the
previous 10-year study for comparison
purposes.
c. FDA should keep chemicals as a
risk factor for future research on the
occurrence of foodborne illness risk
factors.
(Response) FDA acknowledges the
submission of the question from a
concerned citizen and provides the
following response:
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a. FDA acknowledges the
commenter’s concern on a perceived
lack of reporting on negative trends
within the previous 10-year study.
b. FDA report on the results of the
2013 to 2014 data collection was the
first report with the new study design of
the 10-year study. One of the significant
design changes from the 1998 to 2008
Study is the reduction of the number of
data items from 42 to 10. The focus on
the 10 primary data items provides the
opportunity to obtain enough
observations of food safety practices and
procedures to report statistically
significant study conclusions and
correlations.
In an effort to focus messaging on the
most prevalent food safety practices and
behaviors found out of compliance,
secondary data items (items 11–19) were
not reported at that time. FDA focused
the report on the primary 10 data items
that directly correspond with the
foodborne illness risk factors included
in the study. The new study design
includes ‘‘Other Areas of Interest’’ that
support the primary data items or track
an area that is not likely to have a
sufficient enough number of
observations for statistical purposes but
is an important food safety practice
within the retail segment of the
industry—such as Item 18, ‘‘Toxic
materials are identified, used, and
stored properly as outlined in the
marking instructions’’, (Attachment B).
The current data collection continues to
collect information on the provisions
within the food code that address the
safe storage, handling, and use of toxic
and poisonous substances. If significant
findings occur, FDA is committed to
reporting those findings. From the 2015
data collection forward, FDA will be
publishing a topline summary report to
include information on data items 11–
18. These reports can be accessed at
https://www.fda.gov/retailfoodrisk
factorstudy.
c. While not listed as one of the five
main foodborne illness risk factors in
the current study design, controlling
chemicals and toxic substances in food
service facilities is important to prevent
injury and illness and FDA recognizes
this. The information gathered in Data
Item 18 as described above helps FDA
keep a pulse on risky behaviors
surrounding toxic or poisonous
materials in retail facilities. The purpose
of the current 10-year study is primarily
to collect information on the five
foodborne illness risk factors and study
to elucidate relationships between the
foodborne illness risk factors and food
safety management systems, and
certified food protection managers.
To calculate the estimate of the hours
per response, FDA uses the average data
collection duration for similar facility
types during the FDA’s 2008 Risk Factor
Study (Ref. 3) plus an additional 30
minutes (0.5 hours) for the information
related to Section 3, Part B of the form.
FDA estimates that it will take the
persons in charge of healthcare facility
types, schools, and retail food stores 150
minutes (2.5 hours), 120 minutes (2
hours), and 180 minutes (3 hours),
respectively, to accompany the data
collectors while they complete Sections
1 and 3 of the form. 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
healthcare facility types is 180 minutes
(150 + 30) (3 hours), in schools is 150
minutes (120 + 30) (2.5 hours), and
retail food stores is 210 minutes (180 +
30) (3.5 hours).
Based on the number of entry refusals
from the 2015 to 2016 baseline data
collection, we estimate a refusal rate of
2 percent for the data collections within
healthcare, school, and retail food store
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
Activity
2023–2024 Data Collection
(Healthcare Facilities)—
Completion of Sections 1
and 3.
2023–2024 Data Collection
(Schools)—Completion of
Sections 1 and 3.
2023–2024 Data Collection
(Retail Food Stores)—
Completion of Sections 1
and 3.
2023–2024 Data CollectionCompletion of Section 2—
All Facility Types.
2023–2024 Data CollectionEntry Refusals—All Facility
Types.
Total ...............................
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1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Number of
nonrespondents
Number of
responses per
nonrespondent
Total annual
non-responses
Average burden
per
response
Total
hours
400
1
400
........................
........................
........................
2.5 .....................
1,000
400
1
400
........................
........................
........................
2 ........................
800
400
1
400
........................
........................
........................
3 ........................
1,200
1,200
1
1,200
........................
........................
........................
0.5 (30 minutes)
600
........................
........................
........................
24
1
24
0.08 (5 minutes)
1.92
........................
........................
........................
........................
........................
........................
...........................
3,601.92
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
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Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500 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://
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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. ‘‘Report of the FDA Retail Food Program
Database of Foodborne Illness Risk
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Factors (2000).’’ Available at: https://
wayback.archive-it.org/7993/
20170406023019/https://www.fda.gov/
downloads/Food/GuidanceRegulation/
UCM123546.pdf.
2. ‘‘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 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/RetailFood
Protection/FoodborneIllnessRiskFactor
Reduction/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/RetailFood
Protection/FoodborneIllnessRiskFactor
Reduction/ucm223293.htm.
5. ‘‘FDA Food Code.’’ Available at: https://
www.fda.gov/food/retail-food-protection/
fda-food-code.
Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16700 Filed 8–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0771]
Advancing the Development of
Pediatric Therapeutics Complex
Innovative Trial Design; Public
Workshop
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of public workshop.
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AGENCY:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Advancing the Development of
Pediatric Therapeutics (ADEPT 7)
Complex Innovative Trial Design.’’ The
purpose of the public workshop is to
discuss applications of complex and
SUMMARY:
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42849
innovative trial designs in pediatric
clinical trials.
II. Topics for Discussion at the Public
Workshop
The public workshop will be
held virtually on September 1, 2021
(Day 1), from 10 a.m. to 3 p.m. Eastern
Time and September 2, 2021 (Day 2),
from 10 a.m. to 3 p.m. Eastern Time. See
the SUPPLEMENTARY INFORMATION section
for registration information.
The main objective of the ‘‘Advancing
the Development of Pediatric
Therapeutics (ADEPT 7) Complex
Innovative Trial Design’’ workshop is to
discuss opportunities for leveraging
complex and innovative trial designs,
understand the challenges with their
applications, and develop solutions on
how challenges in the designs can be
overcome. The workshop will
specifically focus on two topics of
interest: Bridging biomarkers in
pediatric extrapolation and Bayesian
techniques in pediatric studies. In
addition, the workshop will allow for an
open dialogue around the use of these
approaches among regulators, industry,
academia, and patient organizations.
DATES:
The public workshop will
be held in virtual format only. Please
note that due to the impact of this
COVID–19 pandemic, all meeting
participants will be joining this public
meeting via an online teleconferencing
platform and will not be held at a
specific location.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Evangela Covert, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5234,
Silver Spring, MD 20993, 301–796–
4075, Evangela.Covert@fda.hhs.gov; or
Denise Pica-Branco, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6402,
Silver Spring, MD 20993, 301–796–
4075, Denise.Picabranco@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Over the last two decades, great
advances have been made in pediatric
drug development. In addition, there is
a growing recognition that complex and
innovative trial designs have the
potential to optimize drug development
in small populations. Innovations that
have been proposed include Bayesian
and other methods of utilizing external
historical information from previous
pediatric trials or other populations
(such as adults), adaptive designs,
bridging biomarkers, etc. These designs
tend to require more extensive
discussion and collaboration between
drug developers and regulators to
implement effectively.
The Complex Innovative Trial Design
Pilot Meeting Program (CID Program)
facilitates and advances the use of these
types of designs by providing for
increased interactions between staff in
the Center for Drug Evaluation and
Research and the Center for Biologics
Evaluation and Research and sponsors
accepted into the program. Several
pediatric study designs have been
accepted into the CID Program. This
workshop is being organized in
collaboration with the CID Program.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://go.umd.edu/ADEPT7.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Early registration is
recommended because space is limited;
therefore, FDA may limit the number of
participants from each organization.
If you need special accommodations
due to a disability, please contact
Evangela Covert or Denise PicaBranco (see FOR FURTHER INFORMATION
CONTACT) no later than August 18, 2021,
by 5 p.m. Eastern Time.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast at the following site:
https://collaboration.fda.gov/adept7.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Dated: August 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–16709 Filed 8–4–21; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42845-42849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16700]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0270]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Institutional
Foodservice and Retail Food Stores Facility Types
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 7, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0799. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice and Retail Food Stores Facility Types
OMB Control Number 0910-0799--Extension
I. Background
From 1998 to 2008, 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 were collected by FDA Specialists in retail
and foodservice establishments at 5-year intervals (1998, 2003, and
2008) 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, which were 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 to 2014, FDA
initiated a new study period. This study will span 10 years. FDA
completed the baseline data collection in select healthcare, schools,
and retail food store facility types in 2015 to 2016, and these data
are being evaluated for trends and significance. A second data
collection began in 2019 to 2020 and will be completed if it is safe to
do so (pending COVID-19 pandemic), and an additional data collection is
planned for 2023 to 2024 (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
------------------------------------------------------------------------
Healthcare Facilities............. Hospitals and long-term care
facilities foodservice
operations that prepare meals
for highly susceptible
populations as defined as
follows:
[[Page 42846]]
Hospitals--A foodservice
operation that provides for the
nutritional needs of inpatients
by preparing meals and
transporting them to the
patient's room and/or serving
meals in a cafeteria setting
(meals in the cafeteria may also
be served to hospital staff and
visitors).
Long-term care
facilities--A foodservice
operation that prepares meals
for the residents in a group
care living setting such as
nursing homes and assisted
living facilities.
Note: For the purposes of this
study, healthcare facilities that
do not prepare or serve food to a
highly susceptible population, such
as mental healthcare facilities,
are not included in this facility
type category.
Schools (K-12).................... Foodservice operations that have the
primary function of preparing and
serving meals for students in one
or more grade levels from
kindergarten through grade 12. A
school foodservice may be part of a
public or private institution.
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 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 select
retail food establishments 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 and 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., establishments 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 is to sample establishments that fall under risk categories
2 through 4.
FDA has approximately 23 Regional 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.
[[Page 42847]]
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 institutional foodservice, school,
or retail food store 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--``Foodborne
Illness Risk Factor and Food Safety Management System Assessment''
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 hand washing. 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 hand washing. 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 to 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 FDA 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 incorporating use of 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 2023 to 2024 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 healthcare facility,
school, or supermarket/grocery store); and (2) the program director (or
designated individual) of the respective regulatory authority. 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 three facility
types. Therefore, the total number of responses will be 2,400 (400 data
collections x 3 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 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.
In the Federal Register of February 18, 2021 (86 FR 10087), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
(Comment) An interested citizen submitted the following comment:
a. The previous 10-year study conducted by FDA did not mention
negative trends in the ``other'' category, which included information
about contamination risk factors as they relate to food or color
additives, poisonous or toxic materials, or storage of poisonous or
toxic materials for retail sale. This negative trend should be
reported.
b. In the 2013 to 2014 report on restaurants the ``other''
contamination risk factor did not appear in the report. This should
remain the same as the previous 10-year study for comparison purposes.
c. FDA should keep chemicals as a risk factor for future research
on the occurrence of foodborne illness risk factors.
(Response) FDA acknowledges the submission of the question from a
concerned citizen and provides the following response:
[[Page 42848]]
a. FDA acknowledges the commenter's concern on a perceived lack of
reporting on negative trends within the previous 10-year study.
b. FDA report on the results of the 2013 to 2014 data collection
was the first report with the new study design of the 10-year study.
One of the significant design changes from the 1998 to 2008 Study is
the reduction of the number of data items from 42 to 10. The focus on
the 10 primary data items provides the opportunity to obtain enough
observations of food safety practices and procedures to report
statistically significant study conclusions and correlations.
In an effort to focus messaging on the most prevalent food safety
practices and behaviors found out of compliance, secondary data items
(items 11-19) were not reported at that time. FDA focused the report on
the primary 10 data items that directly correspond with the foodborne
illness risk factors included in the study. The new study design
includes ``Other Areas of Interest'' that support the primary data
items or track an area that is not likely to have a sufficient enough
number of observations for statistical purposes but is an important
food safety practice within the retail segment of the industry--such as
Item 18, ``Toxic materials are identified, used, and stored properly as
outlined in the marking instructions'', (Attachment B). The current
data collection continues to collect information on the provisions
within the food code that address the safe storage, handling, and use
of toxic and poisonous substances. If significant findings occur, FDA
is committed to reporting those findings. From the 2015 data collection
forward, FDA will be publishing a topline summary report to include
information on data items 11-18. These reports can be accessed at
https://www.fda.gov/retailfoodriskfactorstudy.
c. While not listed as one of the five main foodborne illness risk
factors in the current study design, controlling chemicals and toxic
substances in food service facilities is important to prevent injury
and illness and FDA recognizes this. The information gathered in Data
Item 18 as described above helps FDA keep a pulse on risky behaviors
surrounding toxic or poisonous materials in retail facilities. The
purpose of the current 10-year study is primarily to collect
information on the five foodborne illness risk factors and study to
elucidate relationships between the foodborne illness risk factors and
food safety management systems, and certified food protection managers.
To calculate the estimate of the hours per response, FDA uses the
average data collection duration for similar facility types during the
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes
(0.5 hours) for the information related to Section 3, Part B of the
form. FDA estimates that it will take the persons in charge of
healthcare facility types, schools, and retail food stores 150 minutes
(2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours),
respectively, to accompany the data collectors while they complete
Sections 1 and 3 of the form. 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 healthcare facility types is 180 minutes (150 + 30)
(3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and retail
food stores is 210 minutes (180 + 30) (3.5 hours).
Based on the number of entry refusals from the 2015 to 2016
baseline data collection, we estimate a refusal rate of 2 percent for
the data collections within healthcare, school, and retail food store
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 Number of Total annual Number of non- responses per Total annual Total
Activity respondents responses per responses respondents non- non-responses Average burden per response hours
respondent respondent
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2023-2024 Data Collection (Healthcare 400 1 400 .............. .............. .............. 2.5................................. 1,000
Facilities)--Completion of Sections 1 and 3.
2023-2024 Data Collection (Schools)--Completion 400 1 400 .............. .............. .............. 2................................... 800
of Sections 1 and 3.
2023-2024 Data Collection (Retail Food Stores)-- 400 1 400 .............. .............. .............. 3................................... 1,200
Completion of Sections 1 and 3.
2023-2024 Data Collection-Completion of Section 1,200 1 1,200 .............. .............. .............. 0.5 (30 minutes).................... 600
2--All Facility Types.
2023-2024 Data Collection-Entry Refusals--All .............. .............. .............. 24 1 24 0.08 (5 minutes).................... 1.92
Facility Types.
------------------------------------------------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. .............. .............. .............. .................................... 3,601.92
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500 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. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk
[[Page 42849]]
Factors (2000).'' Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.
2. ``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 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 Food Code.'' Available at: https://www.fda.gov/food/retail-food-protection/fda-food-code.
Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16700 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P
