80 FR 35367 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 118 (June 19, 2015)

Page Range		35367-35370
FR Document		2015-15077

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.

Federal Register, Volume 80 Issue 118 (Friday, June 19, 2015)

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35367-35370]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-15077]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2033]

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 July
20, 2015.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title Survey on the Occurrence of Foodborne Illness Risk Factors in
Selected Institutional Foodservice and Retail Food Stores Facility
Types. 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
Institutional Foodservice and Retail Food Stores Facility Types (2015-
2025)

(OMB Control Number 0910-NEW)

I. Background

From 1998-2008, 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) in order to
observe and document trends in the occurrence of the following
foodborne illness risk factors:
Food from Unsafe Sources,
Poor Personal Hygiene,
Inadequate Cooking,
Improper Holding/Time and Temperature and
Contaminated Equipment/Cross-Contamination.
FDA developed reports summarizing the findings for each of the
three data collection periods (1998, 2003, and 2008) (Refs. 1-3). Data
from all three data collection periods were analyzed to detect trends
in improvement or regression over time and to determine whether
progress had been made toward the goal of reducing the occurrence of
foodborne illness risk factors in selected retail and foodservice
facility types (Ref. 4).
Using this 10-year survey as a foundation, in 2013-2014, FDA
initiated a new study in full service and fast food restaurants. This
study will span 10 years with additional data collections planned for
2017-2018 and 2021-2022. FDA is proposing to collect data in select
institutional foodservice and retail food store facility types in 2015-
2016. This proposed study will also span 10 years with additional data
collections planned for 2019-2020 and 2023-2024.

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.

[[Page 35368]]

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 on-site 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:
Meat and seafood department/
operation--Areas in a retail food
store where raw animal food
products, such as beef, pork,
poultry, or seafood, are cut,
prepared, stored, or displayed for
sale to the consumer.
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 (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 methodology to be used for this information collection 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 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 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. 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 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. 5).
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.
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.

[[Page 35369]]

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'' of the form 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 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. Contingent upon the completion of the Web-based platform,
FDA intends to pilot test the use of hand-held technology during its
2015-2016 risk factor study data collection in institutional
foodservice and retail food store facility types, with the goal to have
it fully implemented by the next the data collection in restaurant
facility types that will occur in 2017-2018. 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 17, 2014 (79 FR 75158), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
The burden for this collection of information is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected facility type (whether it be a healthcare
facility, school, or supermarket/grocery store); and (2) the program
director (or designated individual) of the respective regulatory
authority. In order to provide the sufficient number of observations
needed to conduct a statistically significant analysis of the data, FDA
has determined that 400 data collections will be required in each of
the 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 persons in charge to
accompany the data collectors during the site visit and answer the data
collectors' 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 will use
the average data collection duration for similar facility types during
FDA's 2008 Risk Factor Study (Ref. 3) plus an extra 30 minutes (0.5
hours) for the information collection related to section 3, part B of
the form. FDA estimates that it will take the persons in charge of
healthcare facility types, schools, and retail food stores 150 minutes
(2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours),
respectively, to accompany the data collectors while they complete
sections 1 and 3 of the form. FDA estimates that it will take the
program director (or designated individual) of the respective
regulatory authority 30 minutes (0.5 hours) to answer the questions
related to section 2 of the form. The total burden estimate for a data
collection, including both the program director's and the person in
charge's responses, in healthcare facility types is 180 minutes (150 +
30) (3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and in
retail food stores is 210 minutes (180 + 30) (3.5 hours).
Based on the number of entry refusals from the 2013-2014 Risk
Factor Study in the restaurant facility types, we estimate a refusal
rate of 2 percent in the institutional foodservice and retail food
store facility types. The estimate of the time per non-respondent is 5
minutes (0.08 hours) for the person in charge to listen to the purpose
of the visit and provide a verbal refusal of entry.

[[Page 35370]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2015-2016 Data Collection (Healthcare 400 1 400 ........... ........... ........... 2.5 1,000
Facilities)--Completion of Sections 1 and 3....
2015-2016 Data Collection (Schools)--Completion 400 1 400 ........... ........... ........... 2 800
of Sections 1 and 3............................
2015-2016 Data Collection (Retail Food Stores)-- 400 1 400 ........... ........... ........... 3 1,200
Completion of Sections 1 and 3.................
2015-2016 Data Collection-Completion of Section 1,200 1 1,200 ........... ........... ........... 0.5 600
2--All Facility Types..........................
2017-2018 Data Collection-Entry Refusals--All ........... ........... ........... 24 1 24 0.08 1.92
Facility Types................................. (5 minutes)
-------------------------------------------------------------------------------------------------------
Total Hours................................. ........... ........... ........... ........... ........... ........... ........... 3,601.92
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

The following references have 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 are available electronically at http://regulations.gov.

1. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk Factors (2000).'' Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/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: http://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: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224682.pdf.
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: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf.
5. FDA Food Code. Available at: http://www.fda.gov/FoodCode.

Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15077 Filed 6-18-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices 35367

II. Paperwork Reduction Act of 1995 DEPARTMENT OF HEALTH AND Survey on the Occurrence of Foodborne
HUMAN SERVICES Illness Risk Factors in Selected
This guidance contains information Institutional Foodservice and Retail
collection provisions that are subject to Food and Drug Administration Food Stores Facility Types (2015–2025)
review by the Office of Management and
[Docket No. FDA–2014–N–2033] (OMB Control Number 0910-NEW)
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501– Agency Information Collection I. Background
3520). The collection of information Activities; Submission for Office of
requested in the guidance is covered From 1998–2008, FDA’s National
Management and Budget Review;
under FDA regulations at 21 CFR part Comment Request; Survey on the Retail Food Team conducted a study to
314 and approved under OMB control Occurrence of Foodborne Illness Risk measure trends in the occurrence of
Factors in Selected Institutional foodborne illness risk factors,
number 0910–0001.
Foodservice and Retail Food Stores preparation practices, and employee
III. Comments Facility Types behaviors most commonly reported to
the Centers for Disease Control and
Interested persons may submit either AGENCY: Food and Drug Administration, Prevention as contributing factors to
electronic comments regarding this HHS. foodborne illness outbreaks at the retail
document to http://www.regulations.gov ACTION: Notice. level. Specifically, data was collected by
or written comments to the Division of FDA Specialists in retail and
Dockets Management (see ADDRESSES). It SUMMARY: The Food and Drug foodservice establishments at 5-year
is only necessary to send one set of Administration (FDA) is announcing intervals (1998, 2003, and 2008) in order
comments. Identify comments with the that a proposed collection of to observe and document trends in the
docket number found in brackets in the information has been submitted to the occurrence of the following foodborne
Office of Management and Budget illness risk factors:
heading of this document. Received
(OMB) for review and clearance under
comments may be seen in the Division
the Paperwork Reduction Act of 1995. • Food from Unsafe Sources,
of Dockets Management between 9 a.m. • Poor Personal Hygiene,
DATES: Fax written comments on the
and 4 p.m., Monday through Friday, and
collection of information by July 20, • Inadequate Cooking,
will be posted to the docket at http://
www.regulations.gov.
2015. • Improper Holding/Time and
ADDRESSES: To ensure that comments on Temperature and
IV. Electronic Access the information collection are received, • Contaminated Equipment/Cross-
OMB recommends that written Contamination.
Persons with access to the Internet comments be faxed to the Office of
may obtain the document at either FDA developed reports summarizing
Information and Regulatory Affairs, the findings for each of the three data
http://www.fda.gov/Drugs/ OMB, Attn: FDA Desk Officer, FAX:
GuidanceCompliance collection periods (1998, 2003, and
202–395–7285, or emailed to oira_ 2008) (Refs. 1–3). Data from all three
RegulatoryInformation/Guidances/ submission@omb.eop.gov. All data collection periods were analyzed to
default.htm or http:// comments should be identified with the detect trends in improvement or
www.regulations.gov. OMB control number 0910–NEW and regression over time and to determine
Dated: June 15, 2015. title Survey on the Occurrence of whether progress had been made toward
Foodborne Illness Risk Factors in the goal of reducing the occurrence of
Leslie Kux,
Selected Institutional Foodservice and foodborne illness risk factors in selected
Associate Commissioner for Policy. Retail Food Stores Facility Types. Also
[FR Doc. 2015–15076 Filed 6–18–15; 8:45 am]
retail and foodservice facility types (Ref.
include the FDA docket number found 4).
BILLING CODE 4164–01–P in brackets in the heading of this
document. Using this 10-year survey as a
foundation, in 2013–2014, FDA initiated
FOR FURTHER INFORMATION CONTACT: FDA a new study in full service and fast food
PRA Staff, Office of Operations, Food restaurants. This study will span 10
and Drug Administration, 8455 years with additional data collections
Colesville Rd., COLE–14526, Silver planned for 2017–2018 and 2021–2022.
Spring, MD 20993–0002, PRAStaff@ FDA is proposing to collect data in
fda.hhs.gov. select institutional foodservice and
SUPPLEMENTARY INFORMATION: In retail food store facility types in 2015–
compliance with 44 U.S.C. 3507, FDA 2016. This proposed study will also
has submitted the following proposed span 10 years with additional data
collection of information to OMB for collections planned for 2019–2020 and
review and clearance. 2023–2024.

TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
asabaliauskas on DSK5VPTVN1PROD with NOTICES

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.

VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1

35368 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices

TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY—Continued
Facility type Description

Note: For the purposes of this study, healthcare facilities that do not prepare or serve food to a highly sus-
ceptible 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 on-site or re-
ceived from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may in-
clude:
• 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:
• Meat and seafood department/operation—Areas in a retail food store where raw animal food products,
such as beef, pork, poultry, or seafood, are cut, prepared, stored, or displayed for sale to the consumer.
• 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: retail food protection programs and the understanding of the operations within
• Assist FDA with developing retail control of foodborne illness risk factors; each of the facility types to be surveyed.
food safety initiatives and policies and The Specialists are also standardized by
focused on the control of foodborne • Evaluate the impact of industry FDA’s Center for Food Safety and
illness risk factors; food safety management systems in Applied Nutrition personnel in the
• Identify retail food safety work plan controlling the occurrence of foodborne application and interpretation of the
priorities and allocate resources to illness risk factors. FDA Food Code (Ref. 5).
enhance retail food safety nationwide; The methodology to be used for this Sampling zones will be established
• Track changes in the occurrence of information collection is described as which are equal to the 150 mile radius
foodborne illness risk factors in retail follows. In order to obtain a sufficient around a Specialist’s home location.
and foodservice establishments over number of observations to conduct The sample will be selected randomly
time; and statistically significant analysis, FDA from among all eligible establishments
• Inform recommendations to the will conduct approximately 400 data located within these sampling zones.
retail and foodservice industry and collections in each facility type. This The Specialists are generally located in
state, local, tribal, and territorial sample size has been calculated to major metropolitan areas (i.e.
regulatory professionals on reducing the provide for sufficient observations to be population centers) across the
occurrence of foodborne illness risk 95 percent confident that the contiguous United States. Population
factors. compliance percentage is within 5 centers usually contain a large
The statutory basis for FDA percent of the true compliance concentration of the establishments
conducting this study is derived from percentage. FDA intends to sample. Sampling from
the Public Health Service Act (42 U.S.C. A geographical information system the 150 mile radius sampling zones
243, section 311(a)). Responsibility for database containing a listing of around the Specialists’ home locations
carrying out the provisions of the Act businesses throughout the United States provides three advantages to the study:
relative to food protection was will be used as the establishment 1. It provides a cross section of urban
transferred to the Commissioner of Food inventory for the data collections. FDA and rural areas from which to sample
and Drugs in 1968 (21 CFR 5.10(a)(2) will sample establishments from the the eligible establishments.
and (4)). Additionally, the Federal Food, inventory based on the descriptions in 2. It represents a mix of small,
Drug, and Cosmetic Act (21 U.S.C. 301 table 1. FDA does not intend to sample medium, and large regulatory entities
et seq.) and the Economy Act (31 U.S.C. operations that handle only having jurisdiction over the eligible
1535) require FDA to provide assistance prepackaged food items or conduct low establishments.
to other Federal, state, and local risk food preparation activities. The 3. It reduces overnight travel and
government bodies. FDA Food Code contains a grouping of therefore reduces travel costs incurred
The objectives of the study are to: establishments by risk, based on the by the Agency to collect data.
• Identify the foodborne illness risk type of food preparation that is normally The sample for each data collection
factors that are in most need of priority conducted within the operation (Ref. 5). period will be evenly distributed among
attention during each data collection The intent is to sample establishments Specialists. Given that participation in
period; that fall under risk categories 2 through the study by industry is voluntary and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

• Track trends in the occurrence of 4. the status of any given randomly
foodborne illness risk factors over time; FDA has approximately 25 Regional selected establishment is subject to
• Examine potential correlations Retail Food Specialists (Specialists) who change, substitute establishments will
between operational characteristics of will serve as the data collectors for the be selected for each Specialist for cases
food establishments and the control of 10-year study. The Specialists are where the restaurant facility is
foodborne illness risk factors; geographically dispersed throughout the misclassified, closed, or otherwise
• Examine potential correlations United States and possess technical unavailable, unable, or unwilling to
between elements within regulatory expertise in retail food safety and a solid participate.

VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1

Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices 35369

Prior to conducting the data developed and implemented food safety regulatory authority. In order to provide
collection, Specialists will contact the management systems. The information the sufficient number of observations
state or local jurisdiction that has in part C will be collected by making needed to conduct a statistically
regulatory responsibility for conducting direct observations of food employee significant analysis of the data, FDA has
retail food inspections for the selected hand washing. No questions will be determined that 400 data collections
establishment. The Specialist will verify asked in the completion of section 3, will be required in each of the three
with the jurisdiction that the facility has part C of the form. facility types. Therefore, the total
been properly classified for the FDA will collect the following number of responses will be 2,400 (400
purposes of the study and is still in information associated with the data collections × 3 facility types × 2
operation. The Specialist will also establishment’s identity: Establishment respondents per data collection).
ascertain whether the selected facility is name, street address, city, state, zip
code, county, industry segment, and The burden associated with the
under legal notice from the state or local
facility type. The establishment completion of sections 1 and 3 of the
regulatory authority. If the selected
facility is under legal notice, the identifying information is collected to form is specific to the persons in charge
Specialist will not conduct a data ensure the data collections are not of the selected facilities. It includes the
collection, and a substitute duplicative. Other information related time it will take the persons in charge
establishment will be used. An to the nature of the operation, such as to accompany the data collectors during
invitation will be extended to the state seating capacity and number of the site visit and answer the data
or local regulatory authority to employees per shift, will also be collectors’ questions. The burden
accompany the Specialist on the data collected. Data will be consolidated and related to the completion of section 2 of
collection visit. reported in a manner that does not the form is specific to the program
A standard form will be used by the reveal the identity of any establishment directors (or designated individuals) of
Specialists during each data collection. included in the study. the respective regulatory authorities. It
The form is divided into three sections: FDA is working with the National includes the time it will take to answer
Section 1—‘‘Establishment Center for Food Protection and Defense the data collectors’ questions and is the
Information’’; Section 2—‘‘Regulatory to develop a Web-based platform in same regardless of the facility type.
Authority Information’’; and section 3— FoodSHIELD to collect, store, and To calculate the estimate of the hours
‘‘Foodborne Illness Risk Factor and analyze data for the Retail Risk Factor per response, FDA will use the average
Food Safety Management System Study. Once developed, this platform data collection duration for similar
Assessment.’’ The information in will be accessible to state, local, facility types during FDA’s 2008 Risk
section 1—‘‘Establishment Information’’ territorial, and tribal regulatory Factor Study (Ref. 3) plus an extra 30
of the form will be obtained during an jurisdictions to collect data relevant to minutes (0.5 hours) for the information
interview with the establishment owner their own risk factor studies. FDA is collection related to section 3, part B of
or person in charge by the Specialist currently transitioning from the manual the form. FDA estimates that it will take
and will include a standard set of entry of data to the use of hand-held the persons in charge of healthcare
questions. technology. Contingent upon the facility types, schools, and retail food
The information in section 2— completion of the Web-based platform,
stores 150 minutes (2.5 hours), 120
‘‘Regulatory Authority Information’’ will FDA intends to pilot test the use of
minutes (2 hours), and 180 minutes
be obtained during an interview with hand-held technology during its 2015–
(3 hours), respectively, to accompany
the program director of the state or local 2016 risk factor study data collection in
the data collectors while they complete
jurisdiction that has regulatory institutional foodservice and retail food
sections 1 and 3 of the form. FDA
responsibility for conducting store facility types, with the goal to have
inspections for the selected estimates that it will take the program
it fully implemented by the next the
establishment. Section 3 includes three director (or designated individual) of
data collection in restaurant facility
parts: Part A for tabulating the the respective regulatory authority 30
types that will occur in 2017–2018.
Specialists’ observations of the food minutes (0.5 hours) to answer the
When a data collector is assigned a
employees’ behaviors and practices in questions related to section 2 of the
specific establishment, he or she will
limiting contamination, proliferation, form. The total burden estimate for a
conduct the data collection and enter
and survival of food safety hazards; part data collection, including both the
the information into the Web-based data
B for assessing the food safety program director’s and the person in
platform. The interface will support the
management being implemented by the charge’s responses, in healthcare facility
manual entering of data, as well as the
facility; and part C for assessing the types is 180 minutes (150 + 30) (3
ability to upload a fillable PDF.
frequency and extent of food employee In the Federal Register of December hours), in schools is 150 minutes (120
hand washing. The information in part 17, 2014 (79 FR 75158), FDA published + 30) (2.5 hours), and in retail food
A will be collected from the Specialists’ a 60-day notice requesting public stores is 210 minutes (180 + 30) (3.5
direct observations of food employee comment on the proposed collection of hours).
behaviors and practices. Infrequent, information. No comments were Based on the number of entry refusals
nonstandard questions may be asked by received. from the 2013–2014 Risk Factor Study
the Specialists if clarification is needed The burden for this collection of in the restaurant facility types, we
on the food safety procedure or practice information is as follows. For each data estimate a refusal rate of 2 percent in the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

being observed. The information in part collection, the respondents will include: institutional foodservice and retail food
B will be collected by making direct (1) The person in charge of the selected store facility types. The estimate of the
observations and asking follow up facility type (whether it be a healthcare time per non-respondent is 5 minutes
questions of facility management to facility, school, or supermarket/grocery (0.08 hours) for the person in charge to
obtain information on the extent to store); and (2) the program director (or listen to the purpose of the visit and
which the food establishment has designated individual) of the respective provide a verbal refusal of entry.

VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1

35370 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Number of responses Total annual Average
Number of responses Total annual
Activity non- per non- burden per Total hours
respondents per responses respondents non- responses response
respondent respondent

2015–2016 Data Collection (Healthcare Facili-
ties)—Completion of Sections 1 and 3 ......... 400 1 400 .................... .................... .................... 2.5 1,000
2015–2016 Data Collection (Schools)—Com-
pletion of Sections 1 and 3 ........................... 400 1 400 .................... .................... .................... 2 800
2015–2016 Data Collection (Retail Food
Stores)—Completion of Sections 1 and 3 ..... 400 1 400 .................... .................... .................... 3 1,200
2015–2016 Data Collection-Completion of Sec-
tion 2—All Facility Types ............................... 1,200 1 1,200 .................... .................... .................... 0.5 600
2017–2018 Data Collection-Entry Refusals—
All Facility Types ........................................... .................... .................... .................... 24 1 24 0.08 1.92
(5 minutes)

Total Hours ................................................ .................... .................... .................... .................... .................... .................... .................... 3,601.92
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References Dated: June 15, 2015. information to http://
Leslie Kux, www.regulations.gov. Submit written
The following references have been Associate Commissioner for Policy. comments on the collection of
placed on display in the Division of [FR Doc. 2015–15077 Filed 6–18–15; 8:45 am] information to the Division of Dockets
Dockets Management (see ADDRESSES) BILLING CODE 4164–01–P Management (HFA–305), Food and Drug
and may be seen by interested persons Administration, 5630 Fishers Lane, Rm.
between 9 a.m. and 4 p.m., Monday 1061, Rockville, MD 20852. All
through Friday, and are available DEPARTMENT OF HEALTH AND comments should be identified with the
electronically at http://regulations.gov. HUMAN SERVICES docket number found in brackets in the
1. ‘‘Report of the FDA Retail Food Program heading of this document.
Food and Drug Administration FOR FURTHER INFORMATION CONTACT: FDA
Database of Foodborne Illness Risk Factors
(2000).’’ Available at: http://www.fda.gov/ [Docket No. FDA–2012–N–0438] PRA Staff, Office of Operations, Food
downloads/Food/FoodSafety/ and Drug Administration, 8455
RetailFoodProtection/ Agency Information Collection Colesville Rd., COLE–14526, Silver
FoodborneIllnessandRiskFactorReduction/ Activities; Proposed Collection; Spring, MD 20993–0002, PRAStaff@
RetailFoodRiskFactorStudies/ Comment Request; Early Food Safety fda.hhs.gov.
ucm123546.pdf. Evaluation of New Non-Pesticidal
SUPPLEMENTARY INFORMATION: Under the
2. ‘‘FDA Report on the Occurrence of Proteins Produced by New Plant
PRA (44 U.S.C. 3501–3520), Federal
Foodborne Illness Risk Factors in Selected Varieties Intended for Food Use
Agencies must obtain approval from the
Institutional Foodservice, Restaurant, and AGENCY: Food and Drug Administration, Office of Management and Budget
Retail Food Store Facility Types (2004).’’
HHS. (OMB) for each collection of
Available at: http://www.fda.gov/downloads/
ACTION: Notice. information they conduct or sponsor.
Food/GuidanceRegulation/
‘‘Collection of information’’ is defined
RetailFoodProtection/ SUMMARY: The Food and Drug in 44 U.S.C. 3502(3) and 5 CFR
FoodborneIllnessRiskFactorReduction/ Administration (FDA) is announcing an 1320.3(c) and includes Agency requests
UCM423850.pdf opportunity for public comment on the or requirements that members of the
3. ‘‘FDA Report on the Occurrence of proposed collection of certain
Foodborne Illness Risk Factors in Selected
public submit reports, keep records, or
information by the Agency. Under the provide information to a third party.
Institutional Foodservice, Restaurant, and Paperwork Reduction Act of 1995 (the
Retail Food Store Facility Types (2009).’’
Section 3506(c)(2)(A) of the PRA (44
PRA), Federal Agencies must publish a U.S.C. 3506(c)(2)(A)) requires Federal
Available at: http://www.fda.gov/downloads/ notice in the Federal Register
Food/FoodSafety/RetailFoodProtection/ Agencies to provide a 60-day notice in
concerning each proposed collection of the Federal Register concerning each
FoodborneIllnessandRiskFactorReduction/ information, including each proposed
RetailFoodRiskFactorStudies/ proposed collection of information,
extension of an existing collection of including each proposed extension of an
UCM224682.pdf.
information, and allow 60 days for existing collection of information,
4. FDA National Retail Food Team. ‘‘FDA
public comment in response to the before submitting the collection to OMB
Trend Analysis Report on the Occurrence of
notice. This notice solicits comments on for approval. To comply with this
Foodborne Illness Risk Factors in Selected
the information collection provisions of requirement, we are publishing this
Institutional Foodservice, Restaurant, and
FDA’s procedures for early food safety notice of the proposed collection of
Retail Food Store Facility Types (1998–
evaluation of new non-pesticidal information set forth in this document.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

2008).’’ Available at: http://www.fda.gov/
downloads/Food/FoodSafety/
proteins produced by new plant With respect to the following
RetailFoodProtection/
varieties intended for food use, collection of information, we invite
FoodborneIllnessandRiskFactorReduction/ including bioengineered food plants. comments on these topics: (1) Whether
RetailFoodRiskFactorStudies/ DATES: Submit either electronic or the proposed collection of information
UCM224152.pdf. written comments on the collection of is necessary for the proper performance
5. FDA Food Code. Available at: http:// information by August 18, 2015. of our functions, including whether the
www.fda.gov/FoodCode. ADDRESSES: Submit electronic information will have practical utility;
comments on the collection of (2) the accuracy of our estimate of the

VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1

Document Created: 2018-02-22 11:10:23
Document Modified: 2018-02-22 11:10:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by July 20, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 35367

80 FR 35367 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 118 (June 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration