Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types, 43096-43099 [2015-17809]
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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices
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the prevention of food safety problems
before they occur. With the enactment
of FSMA in 2011, the collaboration with
NCFST/IFSH has become increasingly
important as FDA works to fulfill its
mandate to develop a modern,
prevention-based food safety system.
FDA regards the development and
strengthening of public-private
partnerships for research and outreach
on preventive controls to be a key
element of its FSMA implementation
strategy.
This cooperative agreement will
provide continued support so that
NCFST/IFSH can meet the objective to
support the implementation of FSMA
through research, education, and
outreach, with particular emphasis on
identifying the science to support
implementation of preventive controls
associated with manufacturing,
processing, packing, and holding of
human and animal food, and on training
and technical assistance.
C. Eligibility Information
Competition is limited to IIT as FDA
believes IIT’s continued support of the
Food Safety Preventive Controls
Alliance (FSPCA) already established at
NCFST/IFSH uniquely qualifies IIT to
fulfill the objectives of the proposed
cooperative agreement. IIT’s Moffett
Center, where NCFST is located, is a
unique facility that includes offices,
classrooms, a distance-learning center,
and support facilities, which permit
appropriate research, development, and
training activities. The physical layout
of the facility provides maximum
versatility in the use and capability to
simultaneously operate several different
activities related to research,
development, and training to support
FSMA rules. The distance learning
facility located in room 216 in building
91 of the IIT Moffett Campus is
equipped with state-of-the-art audiovisual equipment for conducting and
broadcasting interactive training
programs and workshops to the food
industry, as well as for Webinar
communications with IFSH
stakeholders, including government,
academia, and industry.
Since 1988, IIT has provided an
environment in which scientists from
diverse backgrounds such as academia,
government, and industry have brought
their unique perspectives to focus on
contemporary issues of food safety.
NCFST/IFSH functions as a neutral
ground where scientific exchange about
generic food safety issues occurs freely
and is channeled into the design of
cooperative food safety programs.
Activities at NCFST are focused on
multiple areas associated with food
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safety and FSMA, including but not
limited to, preventive controls for
human and animal foods, supplier
verification, and national training.
Since 2011, IIT has served as the
coordinator of the FSPCA and, since
2012, the Sprout Safety Alliance (SSA),
leveraging the expertise of academia,
industry, and FDA for the purpose of
developing and delivering standardized
curricula related to food safety and
FSMA requirements. In addition to
alliance training, NCFST/IFSH plans to
develop the National Training and
Technical Assistance Network to
provide outreach and technical
assistance to industry in the future. The
new distance-learning training center
developed at the IIT’s Moffett Center
can be used to partially address training
and outreach needs related to FSMA.
Through this facility, training can be
provided on curricula currently being
developed by the FSPCA for human and
animal food and by the SSA for sprouts,
and for training activities related to
other appropriate FSMA activities such
as the Foreign Supplier Verification
Program.
The proposed cooperative activities
will fill existing gaps in knowledge,
food safety training, and expertise for
outreach associated with improving the
safety of foods via FSMA
implementation, and will provide
fundamental food safety information in
the public domain for use by all
segments of the food science community
for industry and regulatory training
activities.
II. Award Information/Funds Available
applicant should first review the full
announcement located at https://
www.grants.gov/. (FDA has verified the
Web site addresses throughout this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.) For the
electronically submitted application, the
following steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Obtain Username &
Password
• Step 4: Authorized Organization
Representative (AOR) Authorization
• Step 5: Track AOR Status
• Step 6: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be
found at https://www07.grants.gov/
applicants/organization_
registration.jsp. Step 6, in detail, can be
found at https://commons.era.nih.gov/
commons/registration/
registrationInstructions.jsp. After you
have followed these steps, submit the
electronic application to: https://
www.grants.gov.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17795 Filed 7–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Award Amount
Food and Drug Administration
The Center for Food Safety and
Applied Nutrition (CFSAN) at FDA
intends to commit up to $5 million in
FY 2015 (direct plus indirect costs) with
the possibility of 2 additional years of
up to $ 7 million each year. Future year
amounts will depend on annual
appropriations and successful
performance.
[Docket No. FDA–2014–N–2076]
B. Length of Support
HHS.
The award will provide 1 year of
support and include future
recommended support for 2 additional
years, contingent upon satisfactory
performance in the achievement of
project and program objectives during
the preceding year and the availability
of Federal fiscal year appropriations.
III. Electronic Application,
Registration, and Submission
Only one electronic application will
be accepted. To submit an electronic
application in response to this FOA, the
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Restaurant Facility
Types
AGENCY:
ACTION:
Food and Drug Administration,
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 August 20,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0744. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
collection of information to OMB for
review and clearance.
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected
Restaurant Facility Types (2013–2022)
OMB Control Number 0910–0744
I. Background
In 2013–2014, the U.S. Food and Drug
Administration (FDA) initiated a study
in two foodservice facility types: Full
service and fast food restaurants. The
study will span 10 years in its entirety
and aims to:
• Assist FDA with developing retail
food safety initiatives and policies
focused on the control of foodborne
illness risk factors—preparation
practices and employee behaviors most
commonly reported to the Centers for
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Disease Control and Prevention as
contributing factors to foodborne illness
outbreaks at the retail level. (i.e. food
from unsafe sources, poor personal
hygiene, inadequate cooking, improper
holding time and temperature, and
contaminated equipment/crosscontamination);
• 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.
TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
Facility type
Description
Full Service Restaurants .............................................
A restaurant where customers place their order at their table, are served their meal at
the table, receive the service of the wait staff, and pay at the end of the meal.
A restaurant that is not a full service restaurant. This includes restaurants commonly referred to as quick service restaurants and fast casual restaurants.
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Fast Food Restaurants ................................................
The statutory basis for FDA
conducting this study is derived from
the Public Health Service Act (42 U.S.C.
243, section 311(a)). Responsibility for
carrying out the provisions of the 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 foodborne illness risk
factors that are in most need of priority
attention during each data collection
period;
• Track trends in the occurrence of
foodborne illness risk factors over time;
• 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
• Evaluate the impact of industry
food safety management systems in
controlling the occurrence of foodborne
illness risk factors.
The data from the 2013–2014
information collection in restaurants is
currently being analyzed by FDA. A
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report summarizing the findings is
expected to be released in 2015. In order
to analyze trends, FDA is proposing to
conduct two additional data collections
in 2017–2018 and 2021–2022 using the
same methodology employed in the
2013–2014 data collection. This
methodology is described as follows.
In order to obtain a sufficient number
of observations to conduct statistically
significant analysis, FDA will conduct
approximately 400 data collections in
each restaurant facility type during each
data collection period. 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
will be used as the establishment
inventory for the data collections. FDA
will sample 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. 1).
The intent is to sample establishments
that fall under risk categories 2 through
4.
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FDA has approximately 25 Regional
Retail Food Specialists (Specialists) who
will 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. 1).
Sampling zones will be established
which are equal to the 150 mile radius
around a Specialist’s home location.
The sample will be 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.
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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 will be 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 will
be selected for each Specialist for cases
where the restaurant facility is
misclassified, closed, or otherwise
unavailable, unable, or unwilling to
participate.
Prior to conducting the data
collection, Specialists will contact the
state or local jurisdiction that has
regulatory responsibility for conducting
retail food inspections for the selected
establishment. The Specialist will verify
with the jurisdiction that the facility has
been properly classified for the
purposes of the study and is still in
operation. The Specialist will also
ascertain 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 will be extended to the state
or local regulatory authority to
accompany the Specialist on the data
collection visit.
A standard form will be 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’’
will be obtained during an interview
with the establishment owner or person
in charge by the Specialist and will
include a standard set of questions.
The information in Section 2—
‘‘Regulatory Authority Information’’ will
be 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 being implemented by the
facility; and Part C for assessing the
frequency and extent of food employee
hand washing. The information in Part
A will be collected from the Specialists’
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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 will be collected by making direct
observations and asking follow up
questions of facility management to
obtain information on the extent to
which the food establishment has
developed and implemented food safety
management systems. The information
in Part C will be collected by making
direct observations of food employee
hand washing. No questions will be
asked in the completion of Section 3,
Part C of the form.
FDA will collect 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 survey is not duplicative.
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, will also be collected. Data will be
consolidated and reported in a manner
that does not reveal the identity of any
establishment included in the study.
FDA is working with the National
Center for Food Protection and Defense
to develop a Web-based platform in
FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor
Study. Once developed, this platform
will be accessible to state, local,
territorial, and tribal regulatory
jurisdictions to collect data relevant to
their own risk factor studies. FDA is
currently transitioning from the manual
entry of data to the use of hand-held
technology. FDA will be pilot testing the
use of hand-held technology during its
2015–2016 risk factor study data
collection in institutional foodservice
and retail food stores, with the goal to
have it fully implemented for the 2017–
2018 data collection in restaurants.
When a data collector is assigned a
specific establishment, he or she will
conduct the data collection and enter
the information into the Web-based data
platform. The interface will support the
manual entering of data, as well as the
ability to upload a fillable PDF.
In the Federal Register of December
11, 2014 (79 FR 73596), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment; however, this comment did
not address the information collection.
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The burden for the 2017–2018 data
collection is as follows. For each data
collection, the respondents will include:
(1) The person in charge of the selected
restaurant facility (whether it be a fast
food or full service restaurant); and (2)
the program director (or designated
individual) of the respective regulatory
authority. In order to provide the
sufficient number of observations
needed to conduct a statistically
significant analysis of the data, FDA has
determined that the same number of
data collections will be required in each
of the two restaurant facility types as
was required in the 2013–2014 data
collection (i.e. 400). Therefore, the total
number of responses for restaurants will
be 1,600 (400 data collections × 2
facility types × 2 respondents per data
collection).
The burden associated with the
completion of Sections 1 and 3 of the
form is specific to the person in charge
of the selected facilities. It includes the
time it will take the person in charge to
accompany the data collector as he or
she completes Sections 1 and 3 of the
form. 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 will use the average
data collection duration for the same
facility types during the 2013–2014 data
collection. FDA estimates that it will
take the persons in charge of full service
restaurants and fast food restaurants 104
minutes (1.73 hours) and 82 minutes
(1.36 hours), respectfully, to accompany
the data collectors while they complete
Sections 1 and 3 of the form. In
comparison, for the 2013–2014 data
collection, the burden estimate was 106
minutes (1.76 hours) in full service
restaurants and 73 minutes (1.21 hours)
in fast food restaurants. FDA estimates
that it will take the program director (or
designated individual) of the respective
regulatory authority 30 minutes (0.5
hours) to answer the questions related to
Section 2 of the form. This burden
estimate is unchanged from the last data
collection. Hence, the total burden
estimate for a data collection in a full
service restaurant, including both the
program director’s and the person in
charge’s responses, is 134 minutes (104
+ 30) (2.23 hours). The total burden
estimate for a data collection in a fast
food restaurant, including both the
program director’s and the person in
charge’s responses, is 112 minutes 82 +
30 (1.86 hours).
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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices
Based on the number of entry refusals
from the 2013–2014 data collection, we
estimate a refusal rate of 2 percent. The
estimate of the time per non-respondent
is five minutes (0.08 hours) for the
person in charge to listen to the purpose
of the visit and provide a verbal refusal
of entry.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Number of
nonrespondents
Number of
responses
per nonrespondent
Total annual
nonresponses
Average
burden per
response
Total hours
400
1
400
....................
....................
....................
1.36
544
2017–2018 Data Collection (Fast Food Restaurants)—Completion
of Sections 1 and 3 ......
2017–2018 Data Collection (Full Service Restaurants)—Completion
of Sections 1 and 3 ......
2017–2018 Data Collection-Completion of Section 2—All Facility
Types ............................
400
1
400
....................
....................
....................
1.73
692
800
1
800
....................
....................
....................
0.5
(30 minutes)
400
2017–2018 Data Collection-Entry Refusals—All
Facility Types ...............
....................
....................
....................
16
1
16
0.08
(5 minutes)
1.28
Total Hours ...............
....................
....................
....................
....................
....................
....................
....................
1,637.28
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. Reference
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and is available
electronically at https://
www.regulations.gov.
1. FDA Food Code available at https://
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/FoodCode/
default.htm.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17809 Filed 7–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
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[Document Identifier: HHS–OS–0990–0424–
30D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
SUMMARY:
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Jkt 235001
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before August 20, 2015
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990–
0424–30D for reference.
Information Collection Request Title:
Pregnancy Assistance Fund (PAF) Study
Abstract: The Office of Adolescent
Health (OAH), U.S. Department of
Health and Human Services (HHS) is
requesting approval by OMB on a
revised data collection. The Pregnancy
Assistance Fund (PAF) Study will
provide information about program
design, implementation, and impacts
through a rigorous assessment of
program impacts and implementation of
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two programs designed to support
expectant and parenting teens. These
programs are located in Houston, Texas
and throughout the state of California.
This revision to this information
collection request includes the 12month follow-up survey instrument
related to the impact study. The data
collected from this instrument in the
two study sites will provide a detailed
understanding of program impacts about
one year after youth are enrolled in the
study, at which time they first have
access to the programming offered by
each site. Clearance is requested for
three years.
Need and Proposed Use of the
Information: The data will serve two
main purposes. First, the data will be
used to determine program effectiveness
by comparing outcomes on repeat
pregnancies, sexual risk behaviors,
health and well-being, and parenting
behaviors between treatment (program)
and control youth. Second, the data will
be used to understand whether the
programs are more effective for some
youth than others. The findings from
these analyses of program impacts will
be of interest to the general public, to
policymakers, and to organizations
interested in supporting expectant and
parenting teens.
Likely Respondents: 1,913 study
participants
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]]>Agencies
[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43096-43099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2076]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Restaurant
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 August
20, 2015.
ADDRESSES: To ensure that comments on the information collection are
received,
[[Page 43097]]
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 oira_submission@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0744. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Restaurant Facility Types (2013-2022)
OMB Control Number 0910-0744
I. Background
In 2013-2014, the U.S. Food and Drug Administration (FDA) initiated
a study in two foodservice facility types: Full service and fast food
restaurants. The study will span 10 years in its entirety and aims to:
Assist FDA with developing retail food safety initiatives
and policies focused on the control 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. (i.e. food from
unsafe sources, poor personal hygiene, inadequate cooking, improper
holding time and temperature, and contaminated equipment/cross-
contamination);
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.
Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
Facility type Description
------------------------------------------------------------------------
Full Service Restaurants............. A restaurant where customers
place their order at their
table, are served their meal at
the table, receive the service
of the wait staff, and pay at
the end of the meal.
Fast Food Restaurants................ A restaurant that is not a full
service restaurant. This
includes restaurants commonly
referred to as quick service
restaurants and fast casual
restaurants.
------------------------------------------------------------------------
The statutory basis for FDA conducting this study is derived from
the Public Health Service Act (42 U.S.C. 243, section 311(a)).
Responsibility for carrying out the provisions of the 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 foodborne illness risk factors that are in
most need of priority attention during each data collection period;
Track trends in the occurrence of foodborne illness risk
factors over time;
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
Evaluate the impact of industry food safety management
systems in controlling the occurrence of foodborne illness risk
factors.
The data from the 2013-2014 information collection in restaurants
is currently being analyzed by FDA. A report summarizing the findings
is expected to be released in 2015. In order to analyze trends, FDA is
proposing to conduct two additional data collections in 2017-2018 and
2021-2022 using the same methodology employed in the 2013-2014 data
collection. This methodology is described as follows.
In order to obtain a sufficient number of observations to conduct
statistically significant analysis, FDA will conduct approximately 400
data collections in each restaurant facility type during each data
collection period. 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 will be used as the
establishment inventory for the data collections. FDA will sample
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. 1). The intent is to sample establishments that fall
under risk categories 2 through 4.
FDA has approximately 25 Regional Retail Food Specialists
(Specialists) who will 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. 1).
Sampling zones will be established which are equal to the 150 mile
radius around a Specialist's home location. The sample will be 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.
[[Page 43098]]
3. It reduces overnight travel and therefore reduces travel costs
incurred by the Agency to collect data.
The sample for each data collection period will be 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 will be
selected for each Specialist for cases where the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
Prior to conducting the data collection, Specialists will contact
the state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist will verify with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist will also ascertain 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 will be extended to the state
or local regulatory authority to accompany the Specialist on the data
collection visit.
A standard form will be 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'' will be obtained during an interview with
the establishment owner or person in charge by the Specialist and will
include a standard set of questions.
The information in Section 2--``Regulatory Authority Information''
will be 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 being implemented by the
facility; and Part C for assessing the frequency and extent of food
employee hand washing. The information in Part A will be 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 will be collected by
making direct observations and asking follow up questions of facility
management to obtain information on the extent to which the food
establishment has developed and implemented food safety management
systems. The information in Part C will be collected by making direct
observations of food employee hand washing. No questions will be asked
in the completion of Section 3, Part C of the form.
FDA will collect 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 survey
is not duplicative. 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, will also be collected.
Data will be consolidated and reported in a manner that does not reveal
the identity of any establishment included in the study.
FDA is working with the National Center for Food Protection and
Defense to develop a Web-based platform in FoodSHIELD to collect,
store, and analyze data for the Retail Risk Factor Study. Once
developed, this platform will be accessible to state, local,
territorial, and tribal regulatory jurisdictions to collect data
relevant to their own risk factor studies. FDA is currently
transitioning from the manual entry of data to the use of hand-held
technology. FDA will be pilot testing the use of hand-held technology
during its 2015-2016 risk factor study data collection in institutional
foodservice and retail food stores, with the goal to have it fully
implemented for the 2017-2018 data collection in restaurants. When a
data collector is assigned a specific establishment, he or she will
conduct the data collection and enter the information into the Web-
based data platform. The interface will support the manual entering of
data, as well as the ability to upload a fillable PDF.
In the Federal Register of December 11, 2014 (79 FR 73596), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment; however, this
comment did not address the information collection.
The burden for the 2017-2018 data collection is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected restaurant facility (whether it be a fast food
or full service restaurant); and (2) the program director (or
designated individual) of the respective regulatory authority. In order
to provide the sufficient number of observations needed to conduct a
statistically significant analysis of the data, FDA has determined that
the same number of data collections will be required in each of the two
restaurant facility types as was required in the 2013-2014 data
collection (i.e. 400). Therefore, the total number of responses for
restaurants will be 1,600 (400 data collections x 2 facility types x 2
respondents per data collection).
The burden associated with the completion of Sections 1 and 3 of
the form is specific to the person in charge of the selected
facilities. It includes the time it will take the person in charge to
accompany the data collector as he or she completes Sections 1 and 3 of
the form. 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 will use
the average data collection duration for the same facility types during
the 2013-2014 data collection. FDA estimates that it will take the
persons in charge of full service restaurants and fast food restaurants
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectfully, to
accompany the data collectors while they complete Sections 1 and 3 of
the form. In comparison, for the 2013-2014 data collection, the burden
estimate was 106 minutes (1.76 hours) in full service restaurants and
73 minutes (1.21 hours) in fast food restaurants. FDA estimates that it
will take the program director (or designated individual) of the
respective regulatory authority 30 minutes (0.5 hours) to answer the
questions related to Section 2 of the form. This burden estimate is
unchanged from the last data collection. Hence, the total burden
estimate for a data collection in a full service restaurant, including
both the program director's and the person in charge's responses, is
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a
data collection in a fast food restaurant, including both the program
director's and the person in charge's responses, is 112 minutes 82 + 30
(1.86 hours).
[[Page 43099]]
Based on the number of entry refusals from the 2013-2014 data
collection, we estimate a refusal rate of 2 percent. The estimate of
the time per non-respondent is five minutes (0.08 hours) for the person
in charge to listen to the purpose of the visit and provide a verbal
refusal of entry.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
Number of responses Total Number of responses Total Average
Activity respondents per annual non- per non- annual non- burden per Total hours
respondent responses respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
2017-2018 Data Collection (Fast Food 400 1 400 ........... ........... ........... 1.36 544
Restaurants)--Completion of Sections 1 and 3...
2017-2018 Data Collection (Full Service 400 1 400 ........... ........... ........... 1.73 692
Restaurants)--Completion of Sections 1 and 3...
2017-2018 Data Collection-Completion of Section 800 1 800 ........... ........... ........... 0.5 400
2--All Facility Types.......................... (30
minutes)
2017-2018 Data Collection-Entry Refusals--All ........... ........... ........... 16 1 16 0.08 1.28
Facility Types................................. (5 minutes)
-------------------------------------------------------------------------------------------------------
Total Hours................................. ........... ........... ........... ........... ........... ........... ........... 1,637.28
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
II. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at https://www.regulations.gov.
1. FDA Food Code available at https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17809 Filed 7-20-15; 8:45 am]
BILLING CODE 4164-01-P
