80_FR_43235 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

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 Range43096-43099
FR Document2015-17809

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]


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

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
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                                                    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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by August 20, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 43096 

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