80 FR 43096 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 139 (July 21, 2015)

Page Range		43096-43099
FR Document		2015-17809

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 139 (Tuesday, July 21, 2015)

[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43096-43099]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-17809]

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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 http://www.regulations.gov.

1. FDA Food Code available at http://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

43096 Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices

the prevention of food safety problems safety and FSMA, including but not applicant should first review the full
before they occur. With the enactment limited to, preventive controls for announcement located at http://
of FSMA in 2011, the collaboration with human and animal foods, supplier www.grants.gov/. (FDA has verified the
NCFST/IFSH has become increasingly verification, and national training. Web site addresses throughout this
important as FDA works to fulfill its Since 2011, IIT has served as the document, but FDA is not responsible
mandate to develop a modern, coordinator of the FSPCA and, since for any subsequent changes to the Web
prevention-based food safety system. 2012, the Sprout Safety Alliance (SSA), sites after this document publishes in
FDA regards the development and leveraging the expertise of academia, the Federal Register.) For the
strengthening of public-private industry, and FDA for the purpose of electronically submitted application, the
partnerships for research and outreach developing and delivering standardized following steps are required:
on preventive controls to be a key curricula related to food safety and • Step 1: Obtain a Dun and Bradstreet
element of its FSMA implementation FSMA requirements. In addition to (DUNS) Number
strategy. alliance training, NCFST/IFSH plans to • Step 2: Register With System for
This cooperative agreement will develop the National Training and Award Management (SAM)
provide continued support so that Technical Assistance Network to • Step 3: Obtain Username &
NCFST/IFSH can meet the objective to provide outreach and technical Password
support the implementation of FSMA assistance to industry in the future. The • Step 4: Authorized Organization
through research, education, and Representative (AOR) Authorization
new distance-learning training center
outreach, with particular emphasis on • Step 5: Track AOR Status
developed at the IIT’s Moffett Center • Step 6: Register With Electronic
identifying the science to support can be used to partially address training
implementation of preventive controls Research Administration (eRA)
and outreach needs related to FSMA. Commons
associated with manufacturing, Through this facility, training can be
processing, packing, and holding of Steps 1 through 5, in detail, can be
provided on curricula currently being found at http://www07.grants.gov/
human and animal food, and on training developed by the FSPCA for human and
and technical assistance. applicants/organization_
animal food and by the SSA for sprouts, registration.jsp. Step 6, in detail, can be
C. Eligibility Information and for training activities related to found at https://commons.era.nih.gov/
other appropriate FSMA activities such commons/registration/
Competition is limited to IIT as FDA
as the Foreign Supplier Verification registrationInstructions.jsp. After you
believes IIT’s continued support of the
Program. have followed these steps, submit the
Food Safety Preventive Controls
The proposed cooperative activities electronic application to: http://
Alliance (FSPCA) already established at
will fill existing gaps in knowledge, www.grants.gov.
NCFST/IFSH uniquely qualifies IIT to
fulfill the objectives of the proposed food safety training, and expertise for
Dated: July 15, 2015.
cooperative agreement. IIT’s Moffett outreach associated with improving the
safety of foods via FSMA Leslie Kux,
Center, where NCFST is located, is a Associate Commissioner for Policy.
unique facility that includes offices, implementation, and will provide
fundamental food safety information in [FR Doc. 2015–17795 Filed 7–20–15; 8:45 am]
classrooms, a distance-learning center,
and support facilities, which permit the public domain for use by all BILLING CODE 4164–01–P

appropriate research, development, and segments of the food science community
training activities. The physical layout for industry and regulatory training
activities. DEPARTMENT OF HEALTH AND
of the facility provides maximum HUMAN SERVICES
versatility in the use and capability to II. Award Information/Funds Available
simultaneously operate several different Food and Drug Administration
activities related to research, A. Award Amount
[Docket No. FDA–2014–N–2076]
development, and training to support The Center for Food Safety and
FSMA rules. The distance learning Applied Nutrition (CFSAN) at FDA Agency Information Collection
facility located in room 216 in building intends to commit up to $5 million in Activities; Submission for Office of
91 of the IIT Moffett Campus is FY 2015 (direct plus indirect costs) with Management and Budget Review;
equipped with state-of-the-art audio- the possibility of 2 additional years of Comment Request; Survey on the
visual equipment for conducting and up to $ 7 million each year. Future year Occurrence of Foodborne Illness Risk
broadcasting interactive training amounts will depend on annual Factors in Selected Restaurant Facility
programs and workshops to the food appropriations and successful Types
industry, as well as for Webinar performance.
communications with IFSH AGENCY: Food and Drug Administration,
stakeholders, including government, B. Length of Support HHS.
academia, and industry. The award will provide 1 year of ACTION: Notice.
Since 1988, IIT has provided an support and include future
environment in which scientists from recommended support for 2 additional SUMMARY: The Food and Drug
diverse backgrounds such as academia, years, contingent upon satisfactory Administration (FDA) is announcing
government, and industry have brought performance in the achievement of that a proposed collection of
their unique perspectives to focus on information has been submitted to the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

project and program objectives during
contemporary issues of food safety. the preceding year and the availability Office of Management and Budget
NCFST/IFSH functions as a neutral of Federal fiscal year appropriations. (OMB) for review and clearance under
ground where scientific exchange about the Paperwork Reduction Act of 1995.
generic food safety issues occurs freely III. Electronic Application, DATES: Fax written comments on the
and is channeled into the design of Registration, and Submission collection of information by August 20,
cooperative food safety programs. Only one electronic application will 2015.
Activities at NCFST are focused on be accepted. To submit an electronic ADDRESSES: To ensure that comments on
multiple areas associated with food application in response to this FOA, the the information collection are received,

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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43097

OMB recommends that written collection of information to OMB for Disease Control and Prevention as
comments be faxed to the Office of review and clearance. contributing factors to foodborne illness
Information and Regulatory Affairs, outbreaks at the retail level. (i.e. food
Survey on the Occurrence of Foodborne
OMB, Attn: FDA Desk Officer, FAX: from unsafe sources, poor personal
Illness Risk Factors in Selected
202–395–7285, or emailed to oira_ hygiene, inadequate cooking, improper
Restaurant Facility Types (2013–2022)
submission@omb.eop.gov. All holding time and temperature, and
comments should be identified with the OMB Control Number 0910–0744 contaminated equipment/cross-
OMB control number 0910–0744. Also contamination);
I. Background
include the FDA docket number found • Identify retail food safety work plan
in brackets in the heading of this In 2013–2014, the U.S. Food and Drug priorities and allocate resources to
document. Administration (FDA) initiated a study enhance retail food safety nationwide;
in two foodservice facility types: Full • Track changes in the occurrence of
FOR FURTHER INFORMATION CONTACT: FDA service and fast food restaurants. The foodborne illness risk factors in retail
PRA Staff, Office of Operations, Food study will span 10 years in its entirety and foodservice establishments over
and Drug Administration, 8455 and aims to: time; and
Colesville Rd., COLE–14526, Silver
• Assist FDA with developing retail • Inform recommendations to the
Spring, MD 20993–0002, PRAStaff@
food safety initiatives and policies retail and foodservice industry and
fda.hhs.gov.
focused on the control of foodborne state, local, tribal, and territorial
SUPPLEMENTARY INFORMATION: In illness risk factors—preparation regulatory professionals on reducing the
compliance with 44 U.S.C. 3507, FDA practices and employee behaviors most occurrence of foodborne illness risk
has submitted the following proposed commonly reported to the Centers for 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 re-
ferred to as quick service restaurants and fast casual restaurants.

The statutory basis for FDA report summarizing the findings is FDA has approximately 25 Regional
conducting this study is derived from expected to be released in 2015. In order Retail Food Specialists (Specialists) who
the Public Health Service Act (42 U.S.C. to analyze trends, FDA is proposing to will serve as the data collectors for the
243, section 311(a)). Responsibility for conduct two additional data collections 10 year study. The Specialists are
carrying out the provisions of the Act in 2017–2018 and 2021–2022 using the geographically dispersed throughout the
relative to food protection was same methodology employed in the United States and possess technical
transferred to the Commissioner of Food 2013–2014 data collection. This expertise in retail food safety and a solid
and Drugs in 1968 (21 CFR 5.10(a)(2) methodology is described as follows. understanding of the operations within
and (4)). Additionally, the Federal Food, In order to obtain a sufficient number each of the facility types to be surveyed.
Drug, and Cosmetic Act (21 U.S.C. 301 of observations to conduct statistically The Specialists are also standardized by
et seq) and the Economy Act (31 U.S.C. significant analysis, FDA will conduct FDA’s Center for Food Safety and
1535) require FDA to provide assistance approximately 400 data collections in Applied Nutrition personnel in the
to other Federal, state, and local each restaurant facility type during each application and interpretation of the
government bodies. data collection period. This sample size FDA Food Code (Ref. 1).
The objectives of the study are to: has been calculated to provide for Sampling zones will be established
• Identify the foodborne illness risk sufficient observations to be 95 percent which are equal to the 150 mile radius
factors that are in most need of priority confident that the compliance around a Specialist’s home location.
attention during each data collection percentage is within 5 percent of the The sample will be selected randomly
period; true compliance percentage. from among all eligible establishments
• Track trends in the occurrence of A geographical information system located within these sampling zones.
foodborne illness risk factors over time; database containing a listing of The Specialists are generally located in
• Examine potential correlations businesses throughout the United States major metropolitan areas (i.e.
between operational characteristics of will be used as the establishment population centers) across the
food establishments and the control of inventory for the data collections. FDA contiguous United States. Population
foodborne illness risk factors; will sample establishments from the centers usually contain a large
• Examine potential correlations inventory based on the descriptions in concentration of the establishments
between elements within regulatory table 1. FDA does not intend to sample FDA intends to sample. Sampling from
retail food protection programs and the operations that handle only the 150 mile radius sampling zones
control of foodborne illness risk factors; prepackaged food items or conduct low
asabaliauskas on DSK5VPTVN1PROD with NOTICES

around the Specialists’ home locations
and risk food preparation activities. The provides three advantages to the study:
• Evaluate the impact of industry FDA Food Code contains a grouping of 1. It provides a cross section of urban
food safety management systems in establishments by risk, based on the and rural areas from which to sample
controlling the occurrence of foodborne type of food preparation that is normally the eligible establishments.
illness risk factors. conducted within the operation (Ref. 1). 2. It represents a mix of small,
The data from the 2013–2014 The intent is to sample establishments medium, and large regulatory entities
information collection in restaurants is that fall under risk categories 2 through having jurisdiction over the eligible
currently being analyzed by FDA. A 4. establishments.

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43098 Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices

3. It reduces overnight travel and direct observations of food employee The burden for the 2017–2018 data
therefore reduces travel costs incurred behaviors and practices. Infrequent, collection is as follows. For each data
by the Agency to collect data. nonstandard questions may be asked by collection, the respondents will include:
The sample for each data collection the Specialists if clarification is needed (1) The person in charge of the selected
period will be evenly distributed among on the food safety procedure or practice restaurant facility (whether it be a fast
Specialists. Given that participation in being observed. The information in Part food or full service restaurant); and (2)
the study by industry is voluntary and B will be collected by making direct the program director (or designated
the status of any given randomly observations and asking follow up individual) of the respective regulatory
selected establishment is subject to questions of facility management to authority. In order to provide the
change, substitute establishments will obtain information on the extent to sufficient number of observations
be selected for each Specialist for cases which the food establishment has needed to conduct a statistically
where the restaurant facility is developed and implemented food safety significant analysis of the data, FDA has
misclassified, closed, or otherwise management systems. The information determined that the same number of
unavailable, unable, or unwilling to in Part C will be collected by making data collections will be required in each
participate. direct observations of food employee of the two restaurant facility types as
Prior to conducting the data hand washing. No questions will be was required in the 2013–2014 data
collection, Specialists will contact the asked in the completion of Section 3, collection (i.e. 400). Therefore, the total
state or local jurisdiction that has Part C of the form. number of responses for restaurants will
regulatory responsibility for conducting FDA will collect the following be 1,600 (400 data collections × 2
retail food inspections for the selected information associated with the facility types × 2 respondents per data
establishment. The Specialist will verify establishment’s identity: Establishment collection).
with the jurisdiction that the facility has name, street address, city, state, zip The burden associated with the
been properly classified for the code, county, industry segment, and completion of Sections 1 and 3 of the
purposes of the study and is still in facility type. The establishment form is specific to the person in charge
operation. The Specialist will also identifying information is collected to of the selected facilities. It includes the
ascertain whether the selected facility is ensure the survey is not duplicative. time it will take the person in charge to
under legal notice from the state or local The establishment identifying accompany the data collector as he or
regulatory authority. If the selected information is collected to ensure the she completes Sections 1 and 3 of the
facility is under legal notice, the data collections are not duplicative. form. The burden related to the
Specialist will not conduct a data Other information related to the nature completion of Section 2 of the form is
collection, and a substitute of the operation, such as seating specific to the program directors (or
establishment will be used. An capacity and number of employees per designated individuals) of the respective
invitation will be extended to the state shift, will also be collected. Data will be regulatory authorities. It includes the
or local regulatory authority to consolidated and reported in a manner time it will take to answer the data
accompany the Specialist on the data that does not reveal the identity of any collectors’ questions and is the same
collection visit. establishment included in the study. regardless of the facility type.
A standard form will be used by the FDA is working with the National To calculate the estimate of the hours
Specialists during each data collection. Center for Food Protection and Defense per response, FDA will use the average
The form is divided into three sections: to develop a Web-based platform in data collection duration for the same
Section 1—‘‘Establishment FoodSHIELD to collect, store, and facility types during the 2013–2014 data
Information;’’ Section 2—‘‘Regulatory analyze data for the Retail Risk Factor collection. FDA estimates that it will
Authority Information;’’ and Section 3— Study. Once developed, this platform take the persons in charge of full service
‘‘Foodborne Illness Risk Factor and will be accessible to state, local, restaurants and fast food restaurants 104
Food Safety Management System territorial, and tribal regulatory minutes (1.73 hours) and 82 minutes
Assessment.’’ The information in jurisdictions to collect data relevant to (1.36 hours), respectfully, to accompany
Section 1—‘‘Establishment Information’’ their own risk factor studies. FDA is the data collectors while they complete
will be obtained during an interview currently transitioning from the manual Sections 1 and 3 of the form. In
with the establishment owner or person entry of data to the use of hand-held comparison, for the 2013–2014 data
in charge by the Specialist and will technology. FDA will be pilot testing the collection, the burden estimate was 106
include a standard set of questions. use of hand-held technology during its minutes (1.76 hours) in full service
The information in Section 2— 2015–2016 risk factor study data restaurants and 73 minutes (1.21 hours)
‘‘Regulatory Authority Information’’ will collection in institutional foodservice in fast food restaurants. FDA estimates
be obtained during an interview with and retail food stores, with the goal to that it will take the program director (or
the program director of the state or local have it fully implemented for the 2017– designated individual) of the respective
jurisdiction that has regulatory 2018 data collection in restaurants. regulatory authority 30 minutes (0.5
responsibility for conducting When a data collector is assigned a hours) to answer the questions related to
inspections for the selected specific establishment, he or she will Section 2 of the form. This burden
establishment. Section 3 includes three conduct the data collection and enter estimate is unchanged from the last data
parts: Part A for tabulating the the information into the Web-based data collection. Hence, the total burden
Specialists’ observations of the food platform. The interface will support the estimate for a data collection in a full
employees’ behaviors and practices in manual entering of data, as well as the service restaurant, including both the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

limiting contamination, proliferation, ability to upload a fillable PDF. program director’s and the person in
and survival of food safety hazards; Part In the Federal Register of December charge’s responses, is 134 minutes (104
B for assessing the food safety 11, 2014 (79 FR 73596), FDA published + 30) (2.23 hours). The total burden
management being implemented by the a 60-day notice requesting public estimate for a data collection in a fast
facility; and Part C for assessing the comment on the proposed collection of food restaurant, including both the
frequency and extent of food employee information. FDA received one program director’s and the person in
hand washing. The information in Part comment; however, this comment did charge’s responses, is 112 minutes 82 +
A will be collected from the Specialists’ not address the information collection. 30 (1.86 hours).

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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43099

Based on the number of entry refusals estimate of the time per non-respondent of the visit and provide a verbal refusal
from the 2013–2014 data collection, we is five minutes (0.08 hours) for the of entry.
estimate a refusal rate of 2 percent. The person in charge to listen to the purpose

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

2017–2018 Data Collec-
tion (Fast Food Res-
taurants)—Completion
of Sections 1 and 3 ...... 400 1 400 .................... .................... .................... 1.36 544
2017–2018 Data Collec-
tion (Full Service Res-
taurants)—Completion
of Sections 1 and 3 ...... 400 1 400 .................... .................... .................... 1.73 692
2017–2018 Data Collec-
tion-Completion of Sec-
tion 2—All Facility
Types ............................ 800 1 800 .................... .................... .................... 0.5 400
(30 minutes)
2017–2018 Data Collec-
tion-Entry Refusals—All
Facility Types ............... .................... .................... .................... 16 1 16 0.08 1.28
(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 Reduction Act of 1995, the Office of the two programs designed to support
The following reference has been Secretary (OS), Department of Health expectant and parenting teens. These
placed on display in the Division of and Human Services, announces plans programs are located in Houston, Texas
Dockets Management (see ADDRESSES) to submit an Information Collection and throughout the state of California.
and may be seen by interested persons Request (ICR), described below, to the This revision to this information
between 9 a.m. and 4 p.m., Monday Office of Management and Budget collection request includes the 12-
through Friday, and is available (OMB). Prior to submitting the ICR to month follow-up survey instrument
electronically at http:// OMB, OS seeks comments from the related to the impact study. The data
www.regulations.gov. public regarding the burden estimate, collected from this instrument in the
below, or any other aspect of the ICR. two study sites will provide a detailed
1. FDA Food Code available at http://
DATES: Comments on the ICR must be understanding of program impacts about
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/FoodCode/ received on or before August 20, 2015 one year after youth are enrolled in the
default.htm. ADDRESSES: Submit your comments to study, at which time they first have
Information.CollectionClearance@ access to the programming offered by
Dated: July 15, 2015. hhs.gov or by calling (202) 690–6162. each site. Clearance is requested for
Leslie Kux, FOR FURTHER INFORMATION CONTACT: three years.
Associate Commissioner for Policy. Information Collection Clearance staff, Need and Proposed Use of the
[FR Doc. 2015–17809 Filed 7–20–15; 8:45 am] Information.CollectionClearance@ Information: The data will serve two
BILLING CODE 4164–01–P hhs.gov or (202) 690–6162. main purposes. First, the data will be
SUPPLEMENTARY INFORMATION: When used to determine program effectiveness
submitting comments or requesting by comparing outcomes on repeat
DEPARTMENT OF HEALTH AND information, please include the
HUMAN SERVICES pregnancies, sexual risk behaviors,
document identifier HHS–OS–0990– health and well-being, and parenting
0424–30D for reference. behaviors between treatment (program)
Office of the Secretary Information Collection Request Title:
and control youth. Second, the data will
[Document Identifier: HHS–OS–0990–0424– Pregnancy Assistance Fund (PAF) Study
be used to understand whether the
30D] Abstract: The Office of Adolescent
Health (OAH), U.S. Department of programs are more effective for some
Agency Information Collection Health and Human Services (HHS) is youth than others. The findings from
Activities; Proposed Collection; Public these analyses of program impacts will
asabaliauskas on DSK5VPTVN1PROD with NOTICES

requesting approval by OMB on a
Comment Request revised data collection. The Pregnancy be of interest to the general public, to
Assistance Fund (PAF) Study will policymakers, and to organizations
AGENCY: Office of the Secretary, HHS. interested in supporting expectant and
ACTION: Notice provide information about program
design, implementation, and impacts parenting teens.
SUMMARY: In compliance with section through a rigorous assessment of Likely Respondents: 1,913 study
3506(c)(2)(A) of the Paperwork program impacts and implementation of participants

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Document Created: 2018-02-23 09:23:15
Document Modified: 2018-02-23 09:23:15

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 August 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 43096

80 FR 43096 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 139 (July 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration