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, 38153-38157 [2018-16648]
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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
The burden estimate has not changed
for information collection related to
section 518(e) of the FD&C Act and part
810 since the last OMB approval.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16618 Filed 8–2–18; 8:45 am]
BILLING CODE 4164–01–P
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0799. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
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,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
4, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types
OMB Control Number 0910–0799—
Reinstatement
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 was collected by
FDA specialists in retail and foodservice
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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/CrossContamination.
FDA developed reports summarizing
the findings for each of the three data
collection periods (1998, 2003, and
2008) (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 in full service and
fast food restaurants. This study will
span 10 years with additional data
collections planned for 2017 to 2018
and 2021 to 2022.
FDA recently completed the baseline
data collection in select healthcare,
school, and retail food store facility
types in 2015 to 2016. This proposed
study will also span 10 years with
additional data collections planned for
2019 to 2020 (the subject of this
information collection request
reinstatement) and 2023 to 2024 (which
will be posted in the Federal Register at
the next renewal).
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:
• 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:
Schools (K–12) .....................
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Retail Food Stores ...............
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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY—Continued
Facility type
Description
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• 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 purpose of the study is to:
• Assist FDA with developing retail
food safety initiatives and policies
focused on the control of foodborne
illness risk factors;
• Identify retail food safety work plan
priorities and allocate resources to
enhance retail food safety nationwide;
• Track changes in the occurrence of
foodborne illness risk factors in retail
and foodservice establishments over
time; and
• Inform recommendations to the
retail and foodservice industry and
State, local, tribal, and territorial
regulatory professionals on reducing the
occurrence of foodborne illness risk
factors.
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 the study are to:
• Identify the least and most often
occurring foodborne illness risk factors
and food safety behaviors/practices in
healthcare, school, restaurant, and retail
food store facility types during each
data collection period;
• Track improvement and/or
regression trends in the occurrence of
foodborne illness risk factors during the
10-year study period;
• Examine potential correlations
between operational characteristics of
food establishments and the control of
foodborne illness risk factors;
• Examine potential correlations
between elements within regulatory
retail food protection programs and the
control of foodborne illness risk factors;
and
• Determine the extent to which food
safety management systems and the
presence of a certified food protection
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manager impact the occurrence of
foodborne illness risk factors.
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 25 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 150-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
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concentration of the establishments
FDA intends to sample. Sampling from
the 150-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 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
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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 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 Institute1 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
1 https://foodprotection.umn.edu/.
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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
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. FDA continues
to assess the feasibility for fully
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.
In the Federal Register of February 7,
2018 (83 FR 5441), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received two
comments.
(Comment 1) National Association of
County and City Health Officials
(NACCHO) provided comments related
to the following areas:
a. Supports FDA’s efforts to reduce
the occurrence of foodborne illness
through the proposed study and
activities on retail food safety.
b. Recommends that Assisted Living
Facilities should be included in the
facility types surveyed in the study.
c. Recommends that FDA interview
food handlers at retail food facilities.
d. Strongly urges FDA to use weighted
random sampling to select retail food
facilities for the study and consider
more factors for establishing sampling
zones.
e. Recommends that FDA work with
State and local health departments to
obtain data needed.
(Response 1) FDA provides the
following responses to the comments
provided by NACCHO:
a. FDA thanks the submitter for
supporting FDA’s efforts to reduce the
occurrence of foodborne illness through
the proposed study and activities on
retail food safety.
b. The information collection
identifies assisted living facilities
within the Long-Term Care category.
The study protocol defines Long-Term
Care Facilities as foodservice operations
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that prepare meals for residents in a
group care living setting such as nursing
homes and assisted living centers.
c. The study data collection protocol
combines direct observations of
procedures and practices and
interaction with both the Person In
Charge and front line food employees.
d. Sampling zones for this
information collection contain
approximately 59 percent of all
healthcare establishments, 59 percent of
all school establishments, and 61
percent of all retail food store
establishments in the contiguous United
States. The sample size of the
information collections provides
sufficient observations to be 95 percent
confident that compliance percentages
derived from the data collections are
within 5 percent of their actual
occurrence.
e. This type of research requires a
standardized design and methodology to
ensure that the occurrences of the
foodborne illness risk factors are
uniformly assessed. Retail Food
Specialists are standardized by the
Center for Food Safety and Applied
Nutrition and have a strong working
knowledge of retail food industry. State
and local regulators are encouraged to
accompany the data collectors during
the data collection.
(Comment 2) Academy of Nutrition
and Dietetics commented that they
support the proposed information
collection for survey on the occurrence
of foodborne illness risk factors in
various settings. The Academy provided
comments pertaining to the following
general areas of the study:
a. Question whether 90 minutes is
adequate for surveying larger facilities.
b. Request FDA evaluate the impact of
conducting surveys during non-peak
hours of operation.
c. Suggest that the use of gloves is not
adequately addressed in the survey.
d. Recommend adding a food allergy
component.
e. Encourage continued efforts to
simplify and standardize expiration
dates. Related to institutional operations
at the retail level, the Academy
provided the following comments:
a. Seeks clarification related to health
systems as to whether FDA will focus
on the central facilities in hospital food
service due to their higher potential
reach, impact, and risk.
b. Seeks clarification whether the
survey will be part of routine
inspections or in addition to them and
whether the information collections will
be scheduled or unannounced.
c. Seeks clarification on how FDA
will analyze the information collected
and which data points will be tied to
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which outcomes. (Response 2) FDA
thanks the submitter for their comment
and appreciates their support. Regarding
general areas of the study, FDA provides
the following responses:
a. The current 10-year study estimates
90 minutes as the average time needed
to adequately collect necessary
information, taking into account both
small and large facilities. This average
time is consistent with the amount of
time burden estimated for the previous
data collection periods and provides a
sufficient timeframe to observe food
safety practices and procedures that are
the focus of the study.
b. Based on the methodology of the
study, the information collection is
performed during hours of operation of
the randomly selected facility. Data
collections are scheduled at times that
provide the best opportunity to observe
food preparation activities.
c. Information collection related to
handwashing and no bare hand contact
with ready-to-eat foods, which may
include use of gloves, is based on
assessment of observations against the
most current edition of the FDA Model
Food Code. Provisions of the Food Code
identify when handwashing and no bare
hand contact with ready-to-eat food are
required during food preparation and
service. The current Food Code does not
recognize the use of hand antiseptics in
lieu of handwashing during food
preparation and service.
d. The study is collecting information
regarding the knowledge of the person
in charge related to food allergens and
training of food service employees on
allergy awareness as it relates to their
assigned duties in their facility.
e. The scope of this data collection
focuses on foodborne illness risk factors
and does not include assessment of
expiration dates of manufactured foods
as part of this research assessment.
Related to institutional operations at the
retail level, FDA provides the following
responses:
a. The data collection protocol
provides the definition of the hospital
facility type that will be the focus of
information collection. It is described as
foodservice operations that provide 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).
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b. The data collections are
unannounced and separate from any
regulatory routine inspections.
Industry’s participation in the study is
voluntary. This methodology allows for
assessment of direct observations
related to the foodborne illness risk
factors during food preparation and
service.
c. The study is designed to investigate
data points focused on the relationship
between food safety management
systems, certified food protection
managers, and the occurrence of risk
factors and food safety behaviors/
practices commonly associated with
foodborne illness in the randomly
selected facility.
Data items 1 through 10 are
considered primary data items. Each of
the primary data items has been placed
under the appropriate FDA foodborne
illness risk factor category that will be
used as the key indicator for FDA’s
statistical analysis for the study:
• Risk Factor—Poor Personal Hygiene
(1) Employees practice proper
handwashing
(2) Food Employees do not contact
ready-to-eat foods with bare hands
• Contaminated Equipment/Protection
from Contamination
(3) Food is protected from crosscontamination during storage,
preparation, and display
(4) Food contact surfaces are properly
cleaned and sanitized
• Improper Holding/Time and
Temperature
(5) Foods requiring refrigeration are
held at the proper temperature
(6) Foods displayed or stored hot are
held at the proper temperature
(7) Foods are cooled properly
(8) Refrigerated, ready-to-eat foods are
properly date marked and discarded
within 7 days of preparation or
opening
• Inadequate Cooking
(9) Raw animal foods are cooked to
required temperatures
(10) Cooked foods are reheated to
required temperatures
The burden for the 2019 to 2020 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
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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. It 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. It 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 uses the average data
collection duration for similar facility
types during the FDA’s 2008 Risk Factor
Study plus an additional 30 minutes
(0.5 hour) for the information related to
Section 2 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 hour) 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
hour) 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:
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
2019–2020 Data Collection
(Healthcare Facilities)—
Completion of Sections 1
and 3.
2019–2020 Data Collection
(Schools)—Completion of
Sections 1 and 3.
2019–2020 Data Collection
(Retail Food Stores)—Completion of Sections 1 and 3.
2019–2020 Data CollectionCompletion of Section 2—All
Facility Types.
2019–2020 Data CollectionEntry Refusals—All Facility
Types.
Total .................................
1 There
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Number of
non-respondents
Number of
responses per
non-respondent
Total
annual
non-responses
Average
burden per
response
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.
The burden for this information
collection has not changed since the last
OMB approval.
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, 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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...........................
Total hours
1. ‘‘Report of the FDA Retail Food Program
Database of Foodborne Illness Risk Factors’’
(2000). Available at: https://wayback.archiveit.org/7993/20170406023019/https://www.
fda.gov/downloads/Food/Guidance
Regulation/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/Retail
FoodProtection/FoodborneIllnessRiskFactor
Reduction/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).’’ Available at: https://wayback.
VerDate Sep<11>2014
18:26 Aug 02, 2018
Jkt 244001
archive-it.org/7993/20170406022950/https://
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/FoodborneIllnessRisk
FactorReduction/ucm223293.htm.
5. ‘‘FDA Food Code.’’ Available at:https://
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/FoodCode/default.htm.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16648 Filed 8–2–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Committee on
Interdisciplinary, Community-Based
Linkages
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Advisory Committee on
Interdisciplinary, Community-Based
Linkages (ACICBL) has scheduled a
public meeting. Information about
ACICBL and the agenda for this meeting
can be found on the ACICBL website at:
https://www.hrsa.gov/advisorycommittees/interdisciplinarycommunity-linkages/.
DATES: August 16, 2018, 8:00 a.m.–2:00
p.m. ET.
ADDRESSES: This meeting will be held
by teleconference and webinar.
• Webinar link: https://
hrsa.connectsolutions.com/acicbl.
• Conference call-in number: 1–800–
324–5531; Passcode: 388458.
FOR FURTHER INFORMATION CONTACT: Joan
Weiss, Ph.D., RN, CRNP, FAAN, Senior
Advisor and Designated Federal Official
(DFO), at Division of Medicine and
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Dentistry, HRSA, 5600 Fishers Lane,
Room 15N39, Rockville, Maryland
20857; 301–443–0430; or jweiss@
hrsa.gov.
ACICBL
provides advice and recommendations
to the Secretary of HHS and to Congress
on a broad range of issues relating to
grant programs authorized by sections
750–760, Title VII, Part D of the Public
Health Service Act. During the August
16, 2018, meeting, ACICBL members
will discuss preparing the current and
future healthcare workforce to practice
in age-friendly health systems within
the context of the quadruple aim. The
quadruple aim focuses on enhancing the
patient experience, improving
population health, and reducing costs
while improving the work life of health
care providers, including clinicians and
staff. ACICBL submits reports to the
Secretary of HHS, the Committee on
Health, Education, Labor, and Pensions
of the Senate, and the Committee on
Energy and Commerce of the House of
Representatives. An agenda will be
posted on the ACICBL website prior to
the meeting. Agenda items are subject to
change as priorities dictate.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to submit a
written statement or make oral
comments to ACICBL should be sent to
Dr. Joan Weiss, DFO, using the contact
information above at least 3 business
days prior to the meeting. Individuals
who plan to attend and need special
assistance or another reasonable
accommodation should notify Dr. Joan
Weiss at the address and phone number
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38153-38157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16648]
-----------------------------------------------------------------------
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, 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: Fax written comments on the collection of information by
September 4, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 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--Reinstatement
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 was 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 (1998, 2003, and 2008) (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 in full service and fast food restaurants. This
study will span 10 years with additional data collections planned for
2017 to 2018 and 2021 to 2022.
FDA recently completed the baseline data collection in select
healthcare, school, and retail food store facility types in 2015 to
2016. This proposed study will also span 10 years with additional data
collections planned for 2019 to 2020 (the subject of this information
collection request reinstatement) and 2023 to 2024 (which will be
posted in the Federal Register at the next renewal).
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:
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:
[[Page 38154]]
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 purpose of the study is to:
Assist FDA with developing retail food safety initiatives
and policies focused on the control of foodborne illness risk factors;
Identify retail food safety work plan priorities and
allocate resources to enhance retail food safety nationwide;
Track changes in the occurrence of foodborne illness risk
factors in retail and foodservice establishments over time; and
Inform recommendations to the retail and foodservice
industry and State, local, tribal, and territorial regulatory
professionals on reducing the occurrence of foodborne illness risk
factors.
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 the study are to:
Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in healthcare,
school, restaurant, and retail food store facility types during each
data collection period;
Track improvement and/or regression trends in the
occurrence of foodborne illness risk factors during the 10-year study
period;
Examine potential correlations between operational
characteristics of food establishments and the control of foodborne
illness risk factors;
Examine potential correlations between elements within
regulatory retail food protection programs and the control of foodborne
illness risk factors; and
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.
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 25 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 150-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 150-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 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
[[Page 38155]]
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 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\1\ 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 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. FDA continues to
assess the feasibility for fully incorporating use of hand-held
technology in subsequent data collections during the 10-year study
period.
---------------------------------------------------------------------------
\1\ https://foodprotection.umn.edu/.
---------------------------------------------------------------------------
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.
In the Federal Register of February 7, 2018 (83 FR 5441), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments.
(Comment 1) National Association of County and City Health
Officials (NACCHO) provided comments related to the following areas:
a. Supports FDA's efforts to reduce the occurrence of foodborne
illness through the proposed study and activities on retail food
safety.
b. Recommends that Assisted Living Facilities should be included in
the facility types surveyed in the study.
c. Recommends that FDA interview food handlers at retail food
facilities.
d. Strongly urges FDA to use weighted random sampling to select
retail food facilities for the study and consider more factors for
establishing sampling zones.
e. Recommends that FDA work with State and local health departments
to obtain data needed.
(Response 1) FDA provides the following responses to the comments
provided by NACCHO:
a. FDA thanks the submitter for supporting FDA's efforts to reduce
the occurrence of foodborne illness through the proposed study and
activities on retail food safety.
b. The information collection identifies assisted living facilities
within the Long-Term Care category. The study protocol defines Long-
Term Care Facilities as foodservice operations that prepare meals for
residents in a group care living setting such as nursing homes and
assisted living centers.
c. The study data collection protocol combines direct observations
of procedures and practices and interaction with both the Person In
Charge and front line food employees.
d. Sampling zones for this information collection contain
approximately 59 percent of all healthcare establishments, 59 percent
of all school establishments, and 61 percent of all retail food store
establishments in the contiguous United States. The sample size of the
information collections provides sufficient observations to be 95
percent confident that compliance percentages derived from the data
collections are within 5 percent of their actual occurrence.
e. This type of research requires a standardized design and
methodology to ensure that the occurrences of the foodborne illness
risk factors are uniformly assessed. Retail Food Specialists are
standardized by the Center for Food Safety and Applied Nutrition and
have a strong working knowledge of retail food industry. State and
local regulators are encouraged to accompany the data collectors during
the data collection.
(Comment 2) Academy of Nutrition and Dietetics commented that they
support the proposed information collection for survey on the
occurrence of foodborne illness risk factors in various settings. The
Academy provided comments pertaining to the following general areas of
the study:
a. Question whether 90 minutes is adequate for surveying larger
facilities.
b. Request FDA evaluate the impact of conducting surveys during
non-peak hours of operation.
c. Suggest that the use of gloves is not adequately addressed in
the survey.
d. Recommend adding a food allergy component.
e. Encourage continued efforts to simplify and standardize
expiration dates. Related to institutional operations at the retail
level, the Academy provided the following comments:
a. Seeks clarification related to health systems as to whether FDA
will focus on the central facilities in hospital food service due to
their higher potential reach, impact, and risk.
b. Seeks clarification whether the survey will be part of routine
inspections or in addition to them and whether the information
collections will be scheduled or unannounced.
c. Seeks clarification on how FDA will analyze the information
collected and which data points will be tied to
[[Page 38156]]
which outcomes. (Response 2) FDA thanks the submitter for their comment
and appreciates their support. Regarding general areas of the study,
FDA provides the following responses:
a. The current 10-year study estimates 90 minutes as the average
time needed to adequately collect necessary information, taking into
account both small and large facilities. This average time is
consistent with the amount of time burden estimated for the previous
data collection periods and provides a sufficient timeframe to observe
food safety practices and procedures that are the focus of the study.
b. Based on the methodology of the study, the information
collection is performed during hours of operation of the randomly
selected facility. Data collections are scheduled at times that provide
the best opportunity to observe food preparation activities.
c. Information collection related to handwashing and no bare hand
contact with ready-to-eat foods, which may include use of gloves, is
based on assessment of observations against the most current edition of
the FDA Model Food Code. Provisions of the Food Code identify when
handwashing and no bare hand contact with ready-to-eat food are
required during food preparation and service. The current Food Code
does not recognize the use of hand antiseptics in lieu of handwashing
during food preparation and service.
d. The study is collecting information regarding the knowledge of
the person in charge related to food allergens and training of food
service employees on allergy awareness as it relates to their assigned
duties in their facility.
e. The scope of this data collection focuses on foodborne illness
risk factors and does not include assessment of expiration dates of
manufactured foods as part of this research assessment. Related to
institutional operations at the retail level, FDA provides the
following responses:
a. The data collection protocol provides the definition of the
hospital facility type that will be the focus of information
collection. It is described as foodservice operations that provide 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).
b. The data collections are unannounced and separate from any
regulatory routine inspections. Industry's participation in the study
is voluntary. This methodology allows for assessment of direct
observations related to the foodborne illness risk factors during food
preparation and service.
c. The study is designed to investigate data points focused on the
relationship between food safety management systems, certified food
protection managers, and the occurrence of risk factors and food safety
behaviors/practices commonly associated with foodborne illness in the
randomly selected facility.
Data items 1 through 10 are considered primary data items. Each of
the primary data items has been placed under the appropriate FDA
foodborne illness risk factor category that will be used as the key
indicator for FDA's statistical analysis for the study:
Risk Factor--Poor Personal Hygiene
(1) Employees practice proper handwashing
(2) Food Employees do not contact ready-to-eat foods with bare
hands
Contaminated Equipment/Protection from Contamination
(3) Food is protected from cross-contamination during storage,
preparation, and display
(4) Food contact surfaces are properly cleaned and sanitized
Improper Holding/Time and Temperature
(5) Foods requiring refrigeration are held at the proper
temperature
(6) Foods displayed or stored hot are held at the proper
temperature
(7) Foods are cooled properly
(8) Refrigerated, ready-to-eat foods are properly date marked and
discarded within 7 days of preparation or opening
Inadequate Cooking
(9) Raw animal foods are cooked to required temperatures
(10) Cooked foods are reheated to required temperatures
The burden for the 2019 to 2020 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. It 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. It 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 uses the
average data collection duration for similar facility types during the
FDA's 2008 Risk Factor Study plus an additional 30 minutes (0.5 hour)
for the information related to Section 2 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
hour) 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 hour) 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:
[[Page 38157]]
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total Number of
Activity Number of responses per annual Number of non- responses per Total annual Average burden Total
respondents respondent responses respondents non-respondent non-responses per response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
2019-2020 Data Collection 400 1 400 ................ ............... .............. 2.5............... 1,000
(Healthcare Facilities)--
Completion of Sections 1
and 3.
2019-2020 Data Collection 400 1 400 ................ ............... .............. 2................. 800
(Schools)--Completion of
Sections 1 and 3.
2019-2020 Data Collection 400 1 400 ................ ............... .............. 3................. 1,200
(Retail Food Stores)--
Completion of Sections 1
and 3.
2019-2020 Data Collection- 1,200 1 1,200 ................ ............... .............. 0.5 (30 minutes).. 600
Completion of Section 2--
All Facility Types.
2019-2020 Data Collection- ........... .............. .......... 24 1 24 0.08 (5 minutes).. 1.92
Entry Refusals--All
Facility Types.
---------------------------------------------------------------------------------------------------------------------------
Total................... ........... .............. .......... ................ ............... .............. .................. 3,601.92
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information collection has not changed since
the last OMB approval.
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, 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 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).'' 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/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16648 Filed 8-2-18; 8:45 am]
BILLING CODE 4164-01-P
