83_FR_5467 83 FR 5441 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types

83 FR 5441 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

Page Range5441-5445
FR Document2018-02413

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types.''

Federal Register, Volume 83 Issue 26 (Wednesday, February 7, 2018)
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5441-5445]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0270]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey on the Occurrence of Foodborne Illness Risk 
Factors in Selected Institutional Foodservice and Retail Food Stores 
Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed reinstatement of an existing collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the ``Survey on the Occurrence of Foodborne 
Illness Risk Factors in Selected Institutional Foodservice and Retail 
Food Stores Facility Types.''

DATES: Submit either electronic or written comments on the collection 
of information by April 9, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 9, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any

[[Page 5442]]

confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-0270 for ``Survey on the Occurrence of Foodborne Illness 
Risk Factors in Selected Institutional Foodservice and Retail Food 
Stores Facility Types.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed reinstatement of an existing collection of information 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected 
Institutional Foodservice and Retail Food Stores Facility Types

OMB Control Number 0910-0799--Reinstatement

I. Background
    From 1998 to 2008, FDA's National Retail Food Team conducted a 
study to measure trends in the occurrence of foodborne illness risk 
factors, preparation practices, and employee behaviors most commonly 
reported to the Centers for Disease Control and Prevention as 
contributing factors to foodborne illness outbreaks at the retail 
level. Specifically, data was collected by FDA specialists in retail 
and foodservice establishments at 5-year intervals (1998, 2003, and 
2008) to observe and document trends in the occurrence of the following 
foodborne illness risk factors:
     Food from Unsafe Sources,
     Poor Personal Hygiene,
     Inadequate Cooking,
     Improper Holding/Time and Temperature, and
     Contaminated Equipment/Cross-Contamination.
    FDA developed reports summarizing the findings for each of the 
three data collection periods (1998, 2003, and 2008) (Refs. 1 to 3). 
Data from all three data collection periods were analyzed to detect 
trends in improvement or regression over time and to determine whether 
progress had been made toward the goal of reducing the occurrence of 
foodborne illness risk factors in selected retail and foodservice 
facility types (Ref. 4).
    Using this 10-year survey as a foundation, in 2013-2014, FDA 
initiated a new study in full service and fast food restaurants. This 
study will span 10 years with additional data collections planned for 
2017-2018 and 2021-2022.
    FDA recently completed the baseline data collection in select 
health care, school, and retail food store facility types in 2015-2016. 
This proposed study will also span 10 years with additional data 
collections planned for 2019-2020 (the subject of this information 
collection request reinstatement) and 2023-2024 (which

[[Page 5443]]

will be posted in the Federal Register at the next renewal).

    Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
        Facility type                         Description
------------------------------------------------------------------------
Health Care Facilities.......  Hospitals and long-term care facilities
                                foodservice operations that prepare
                                meals for highly susceptible populations
                                as defined as follows:
                                Hospitals--A foodservice
                                operation that provides for the
                                nutritional needs of inpatients by
                                preparing meals and transporting them to
                                the patient's room and/or serving meals
                                in a cafeteria setting (meals in the
                                cafeteria may also be served to hospital
                                staff and visitors).
                                Long-term care facilities--A
                                foodservice operation that prepares
                                meals for the residents in a group care
                                living setting such as nursing homes and
                                assisted living facilities.
                               Note: For the purposes of this study,
                                health care facilities that do not
                                prepare or serve food to a highly
                                susceptible population, such as mental
                                health care facilities, are not included
                                in this facility type category.
Schools (K-12)...............  Foodservice operations that have the
                                primary function of preparing and
                                serving meals for students in one or
                                more grade levels from kindergarten
                                through grade 12. A school foodservice
                                may be part of a public or private
                                institution.
Retail Food Stores...........  Supermarkets and grocery stores that have
                                a deli department/operation as described
                                as follows:
                                Deli department/operation--Areas
                                in a retail food store where foods, such
                                as luncheon meats and cheeses, are
                                sliced for the customers and where
                                sandwiches and salads are prepared
                                onsite or received from a commissary in
                                bulk containers, portioned, and
                                displayed. Parts of deli operations may
                                include:
                                Salad bars, pizza stations, and
                                other food bars managed by the deli
                                department manager.
                                Areas where other foods are
                                cooked or prepared and offered for sale
                                as ready-to-eat and are managed by the
                                deli department manager.
                               Data will also be collected in the
                                following areas of a supermarket or
                                grocery store, if present:
                                Seafood department/operation--
                                Areas in a retail food store where
                                seafood is cut, prepared, stored, or
                                displayed for sale to the consumer. In
                                retail food stores where the seafood
                                department is combined with another
                                department (e.g. meat), the data
                                collector will only assess the
                                procedures and practices associated with
                                the processing of seafood.
                                Produce department/operation--
                                Areas in a retail food store where
                                produce is cut, prepared, stored, or
                                displayed for sale to the consumer. A
                                produce operation may include salad bars
                                or juice stations that are managed by
                                the produce manager.
------------------------------------------------------------------------

    The purpose of the study is to:
     Assist FDA with developing retail food safety initiatives 
and policies focused on the control of foodborne illness risk factors;
     Identify retail food safety work plan priorities and 
allocate resources to enhance retail food safety nationwide;
     Track changes in the occurrence of foodborne illness risk 
factors in retail and foodservice establishments over time; and
     Inform recommendations to the retail and foodservice 
industry and State, local, tribal, and territorial regulatory 
professionals on reducing the occurrence of foodborne illness risk 
factors.
    The statutory basis for FDA conducting this study is derived from 
the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 
311(a)). Responsibility for carrying out the provisions of the PHS Act 
relative to food protection was transferred to the Commissioner of Food 
and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the 
Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other 
Federal, State, and local government bodies.
    The objectives of the study are to:
     Identify the least and most often occurring foodborne 
illness risk factors and food safety behaviors/practices in health 
care, school, restaurant, and retail food store facility types during 
each data collection period;
     Track improvement and/or regression trends in the 
occurrence of foodborne illness risk factors during the 10-year study 
period;
     Examine potential correlations between operational 
characteristics of food establishments and the control of foodborne 
illness risk factors;
     Examine potential correlations between elements within 
regulatory retail food protection programs and the control of foodborne 
illness risk factors; and
     Determine the extent to which food safety management 
systems and the presence of a certified food protection manager impact 
the occurrence of foodborne illness risk factors.
    The methodology to be used for this information collection is 
described as follows. To obtain a sufficient number of observations to 
conduct statistically significant analysis, FDA will conduct 
approximately 400 data collections in each facility type. This sample 
size has been calculated to provide for sufficient observations to be 
95 percent confident that the compliance percentage is within 5 percent 
of the true compliance percentage.
    A geographical information system database containing a listing of 
businesses throughout the United States provides the establishment 
inventory for the data collections. FDA samples establishments from the 
inventory based on the descriptions in table 1. FDA does not intend to 
sample operations that handle only prepackaged food items or conduct 
low-risk food preparation activities. The ``FDA Food Code'' contains a 
grouping of establishments by risk, based on the type of food 
preparation that is normally conducted within the operation (Ref. 5). 
The intent is to sample establishments that fall under risk categories 
2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists 
(Specialists) who serve as the data collectors for the 10-year study. 
The Specialists are geographically dispersed throughout the United 
States and possess technical expertise in retail food safety and a 
solid understanding of the operations within each of the facility types 
to be surveyed. The Specialists are also standardized by FDA's Center 
for Food Safety and Applied Nutrition personnel in the application and 
interpretation of the FDA Food Code (Ref. 5).
    Sampling zones have been established that are equal to the 150-mile 
radius

[[Page 5444]]

around a Specialist's home location. The sample is selected randomly 
from among all eligible establishments located within these sampling 
zones. The Specialists are generally located in major metropolitan 
areas (i.e., population centers) across the contiguous United States. 
Population centers usually contain a large concentration of the 
establishments FDA intends to sample. Sampling from the 150-mile radius 
sampling zones around the Specialists' home locations provides three 
advantages to the study:
    1. It provides a cross-section of urban and rural areas from which 
to sample the eligible establishments.
    2. It represents a mix of small, medium, and large regulatory 
entities having jurisdiction over the eligible establishments.
    3. It reduces overnight travel and therefore reduces travel costs 
incurred by the Agency to collect data.
    The sample for each data collection period is evenly distributed 
among Specialists. Given that participation in the study by industry is 
voluntary and the status of any given randomly selected establishment 
is subject to change, substitute establishments have been selected for 
each Specialist for cases where the institutional foodservice, school, 
or retail food store facility is misclassified, closed, or otherwise 
unavailable, unable, or unwilling to participate.
    Prior to conducting the data collection, Specialists contact the 
State or local jurisdiction that has regulatory responsibility for 
conducting retail food inspections for the selected establishment. The 
Specialist verifies with the jurisdiction that the facility has been 
properly classified for the purposes of the study and is still in 
operation. The Specialist ascertains whether the selected facility is 
under legal notice from the State or local regulatory authority. If the 
selected facility is under legal notice, the Specialist will not 
conduct a data collection, and a substitute establishment will be used. 
An invitation is extended to the State or local regulatory authority to 
accompany the Specialist on the data collection visit.
    A standard form is used by the Specialists during each data 
collection. The form is divided into three sections: Section 1--
``Establishment Information''; Section 2--``Regulatory Authority 
Information''; and Section 3--``Foodborne Illness Risk Factor and Food 
Safety Management System Assessment''. The information in Section 1--
``Establishment Information'' of the form is obtained during an 
interview with the establishment owner or person in charge by the 
Specialist and includes a standard set of questions.
    The information in Section 2--``Regulatory Authority Information'' 
is obtained during an interview with the program director of the State 
or local jurisdiction that has regulatory responsibility for conducting 
inspections for the selected establishment. Section 3 includes three 
parts: Part A for tabulating the Specialists' observations of the food 
employees' behaviors and practices in limiting contamination, 
proliferation, and survival of food safety hazards; Part B for 
assessing the food safety management system being implemented by the 
facility; and Part C for assessing the frequency and extent of food 
employee hand washing. The information in Part A is collected from the 
Specialists' direct observations of food employee behaviors and 
practices. Infrequent, nonstandard questions may be asked by the 
Specialists if clarification is needed on the food safety procedure or 
practice being observed. The information in Part B is collected by 
making direct observations and asking 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 is collected by making direct 
observations of food employee hand washing. No questions are asked in 
the completion of Section 3, Part C of the form.
    FDA collects the following information associated with the 
establishment's identity: Establishment name, street address, city, 
state, ZIP code, county, industry segment, and facility type. The 
establishment identifying information is collected to ensure the data 
collections are not duplicative. Other information related to the 
nature of the operation, such as seating capacity and number of 
employees per shift, is also collected. Data will be consolidated and 
reported in a manner that does not reveal the identity of any 
establishment included in the study.
    FDA has collaborated with the Food Protection and Defense Institute 
to develop a web-based platform in FoodSHIELD to collect, store, and 
analyze data for the Retail Risk Factor Study. This platform is 
accessible to State, local, territorial, and tribal regulatory 
jurisdictions to collect data relevant to their own risk factor 
studies. For the 2015-2016 data collection, FDA piloted the use of 
hand-held technology for capturing the data onsite during the data 
collection visits. The tablets that were made available for the data 
collections were part of a broader Agency initiative focused on 
internal uses of hand-held technology. The tablets provided for the 
data collection presented several technical and logistical challenges 
and increased the time burden associated with the data collection as 
compared to the manual entry of data collections. FDA continues to 
assess the feasibility for fully incorporating use of hand-held 
technology in subsequent data collections during the 10-year study 
period.
    When a data collector is assigned a specific establishment, he or 
she conducts the data collection and enters the information into the 
web-based data platform. The interface will support the manual entering 
of data, as well as the ability to directly enter information in the 
database via a web browser.
    The burden for the 2019-2020 data collection is as follows. For 
each data collection, the respondents will include: (1) The person in 
charge of the selected facility (whether it be a health care facility, 
school, or supermarket/grocery store) and (2) the program director (or 
designated individual) of the respective regulatory authority. To 
provide the sufficient number of observations needed to conduct a 
statistically significant analysis of the data, FDA has determined that 
400 data collections will be required in each of the three facility 
types. Therefore, the total number of responses will be 2,400 (400 data 
collections x 3 facility types x 2 respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of 
the form is specific to the persons in charge of the selected 
facilities. It includes the time it will take the person in charge to 
accompany the data collector during the site visit and answer the data 
collector's questions. The burden related to the completion of Section 
2 of the form is specific to the program directors (or designated 
individuals) of the respective regulatory authorities. It includes the 
time it will take to answer the data collectors' questions and is the 
same regardless of the facility type.
    To calculate the estimate of the hours per response, FDA uses the 
average data collection duration for similar facility types during the 
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes 
(0.5 hours) for the information related to Section 3, Part B of the 
form. FDA estimates that it will take the persons in charge of health 
care facility types, schools, and retail food stores 150 minutes (2.5 
hours), 120 minutes (2 hours), and 180 minutes (3 hours), respectively, 
to accompany the data

[[Page 5445]]

collectors while they complete Sections 1 and 3 of the form. FDA 
estimates that it will take the program director (or designated 
individual) of the respective regulatory authority 30 minutes (0.5 
hours) to answer the questions related to Section 2 of the form. This 
burden estimate is unchanged from the last data collection. Hence, the 
total burden estimate for a data collection in health care facility 
types is 180 minutes (150 + 30) (3 hours), in schools is 150 minutes 
(120 + 30) (2.5 hours), and retail food stores is 210 minutes (180 + 
30) (3.5 hours).
    Based on the number of entry refusals from the 2015-2016 baseline 
data collection, we estimate a refusal rate of 2 percent for the data 
collections within health care, school, and retail food store facility 
types. The estimate of the time per non-respondent is 5 minutes (0.08 
hours) for the person in charge to listen to the purpose of the visit 
and provide a verbal refusal of entry.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 2--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Number of                              Number of
                                      Number of    responses      Total      Number of    responses      Total         Average  burden per       Total
              Activity               respondents      per         annual        non-       per non-   annual non-           response             hours
                                                   respondent   responses   respondents   respondent   responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
2019-2020 Data Collection (Health            400            1          400  ...........  ...........  ...........  2.5.......................      1,000
 Care Facilities)--Completion of
 Sections 1 and 3.
2019-2020 Data Collection                    400            1          400  ...........  ...........  ...........  2.........................        800
 (Schools)--Completion of Sections
 1 and 3.
2019-2020 Data Collection (Retail            400            1          400  ...........  ...........  ...........  3.........................      1,200
 Food Stores)--Completion of
 Sections 1 and 3.
2019-2020 Data Collection-                 1,200            1        1,200  ...........  ...........  ...........  .5 (30 minutes)...........        600
 Completion of Section 2--All
 Facility Types.
2019-2020 Data Collection-Entry      ...........  ...........  ...........           24            1           24  .08 (5 minutes)...........       1.92
 Refusals--All Facility Types.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........  ...........  ...........  ...........  ...........  ...........  ..........................   3,601.92
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden for this information collection has not changed since 
the last OMB approval.
II. References
    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. ``Report of the FDA Retail Food Program Database of Foodborne 
Illness Risk Factors'' (2000). Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.
2. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors 
in Selected Institutional Foodservice, Restaurant, and Retail Food 
Store Facility Types'' (2004). Available at: https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf.
3. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors 
in Selected Institutional Foodservice, Restaurant, and Retail Food 
Store Facility Types'' (2009). Available at: https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm.
4. FDA National Retail Food Team. ``FDA Trend Analysis Report on the 
Occurrence of Foodborne Illness Risk Factors in Selected 
Institutional Foodservice, Restaurant, and Retail Food Store 
Facility Types (1998-2008).'' Available at: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
5. ``FDA Food Code.'' Available at: https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.

    Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02413 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P



                                                                           Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices                                            5441

                                                product. Although only a portion of a                   initially submitted on September 19,                  DEPARTMENT OF HEALTH AND
                                                regulatory review period may count                      2014.                                                 HUMAN SERVICES
                                                toward the actual amount of extension                     3. The date the application was
                                                that the Director of USPTO may award                                                                          Food and Drug Administration
                                                                                                        approved: December 3, 2014. FDA has
                                                (for example, half the testing phase must                                                                     [Docket No. FDA–2018–N–0270]
                                                                                                        verified the applicant’s claim that BLA
                                                be subtracted as well as any time that
                                                                                                        125557 was approved on December 3,
                                                may have occurred before the patent                                                                           Agency Information Collection
                                                was issued), FDA’s determination of the                 2014.
                                                                                                                                                              Activities; Proposed Collection;
                                                length of a regulatory review period for                  This determination of the regulatory                Comment Request; Survey on the
                                                a human biological product will include                 review period establishes the maximum                 Occurrence of Foodborne Illness Risk
                                                all of the testing phase and approval                   potential length of a patent extension.               Factors in Selected Institutional
                                                phase as specified in 35 U.S.C.                         However, the USPTO applies several                    Foodservice and Retail Food Stores
                                                156(g)(1)(B).                                           statutory limitations in its calculations             Facility Types
                                                   FDA has approved for marketing the                   of the actual period for patent extension.
                                                human biologic product BLINCYTO                                                                               AGENCY:    Food and Drug Administration,
                                                                                                        In its applications for patent extension,
                                                (blinatumomab). BLINCYTO is                                                                                   HHS.
                                                                                                        this applicant seeks 1,462 or 432 days
                                                indicated for the treatment of                                                                                ACTION:   Notice.
                                                                                                        of patent term extension.
                                                Philadelphia chromosome-negative
                                                                                                                                                              SUMMARY:   The Food and Drug
                                                relapsed or refractory B-cell precuror                  III. Petitions
                                                                                                                                                              Administration (FDA or Agency) is
                                                acute lymphoblastic leukemia. This
                                                                                                           Anyone with knowledge that any of                  announcing an opportunity for public
                                                indication is approved under
                                                                                                        the dates as published are incorrect may              comment on the proposed collection of
                                                accelerated approval. Continued
                                                                                                        submit either electronic or written                   certain information by the Agency.
                                                approval for this indication may be
                                                                                                        comments and, under 21 CFR 60.24, ask                 Under the Paperwork Reduction Act of
                                                contingent upon verification of clinical
                                                benefit in subsequent trials. Subsequent                for a redetermination (see DATES).                    1995 (PRA), Federal Agencies are
                                                to this approval, the USPTO received                    Furthermore, as specified in § 60.30 (21              required to publish notice in the
                                                patent term restoration applications for                                                                      Federal Register concerning each
                                                                                                        CFR 60.30), any interested person may
                                                BLINCYTO (U.S. Patent Nos. 7,112,324                                                                          proposed collection of information,
                                                                                                        petition FDA for a determination
                                                and 8,007,796) from Amgen Research                                                                            including each proposed reinstatement
                                                                                                        regarding whether the applicant for
                                                (Munich) GMBH, and the USPTO                                                                                  of an existing collection of information,
                                                                                                        extension acted with due diligence                    and to allow 60 days for public
                                                requested FDA’s assistance in                           during the regulatory review period. To
                                                determining this patent’s eligibility for                                                                     comment in response to the notice. This
                                                                                                        meet its burden, the petition must                    notice solicits comments on the ‘‘Survey
                                                patent term restoration. In a letter dated              comply with all the requirements of
                                                October 30, 2015, FDA advised the                                                                             on the Occurrence of Foodborne Illness
                                                                                                        § 60.30, including but not limited to:                Risk Factors in Selected Institutional
                                                USPTO that this human biological                        must be timely (see DATES), must be
                                                product had undergone a regulatory                                                                            Foodservice and Retail Food Stores
                                                                                                        filed in accordance with § 10.20, must                Facility Types.’’
                                                review period and that the approval of
                                                                                                        contain sufficient facts to merit an FDA              DATES: Submit either electronic or
                                                BLINCYTO represented the first
                                                permitted commercial marketing or use                   investigation, and must certify that a                written comments on the collection of
                                                of the product. Thereafter, the USPTO                   true and complete copy of the petition                information by April 9, 2018.
                                                requested that FDA determine the                        has been served upon the patent                       ADDRESSES: You may submit comments
                                                product’s regulatory review period.                     applicant. (See H. Rept. 857, part 1, 98th            as follows. Please note that late,
                                                                                                        Cong., 2d sess., pp. 41–42, 1984.)                    untimely filed comments will not be
                                                II. Determination of Regulatory Review                  Petitions should be in the format                     considered. Electronic comments must
                                                Period                                                  specified in 21 CFR 10.30.                            be submitted on or before April 9, 2018.
                                                   FDA has determined that the                             Submit petitions electronically to                 The https://www.regulations.gov
                                                applicable regulatory review period for                 https://www.regulations.gov at Docket                 electronic filing system will accept
                                                BLINCYTO is 2,850 days. Of this time,                   No. FDA–2013–S–0610. Submit written                   comments until midnight Eastern Time
                                                2,774 days occurred during the testing                                                                        at the end of April 9, 2018. Comments
                                                                                                        petitions (two copies are required) to the
                                                phase of the regulatory review period,                                                                        received by mail/hand delivery/courier
                                                                                                        Dockets Management Staff (HFA–305),
                                                while 76 days occurred during the                                                                             (for written/paper submissions) will be
                                                                                                        Food and Drug Administration, 5630
                                                approval phase. These periods of time                                                                         considered timely if they are
                                                were derived from the following dates:                  Fishers Lane, Rm. 1061, Rockville, MD
                                                                                                                                                              postmarked or the delivery service
                                                   1. The date an exemption under                       20852.
                                                                                                                                                              acceptance receipt is on or before that
                                                section 505(i) of the Federal Food, Drug,                 Dated: January 31, 2018.                            date.
                                                and Cosmetic Act (21 U.S.C. 355(i))                     Leslie Kux,
                                                became effective: February 15, 2007.                                                                          Electronic Submissions
                                                                                                        Associate Commissioner for Policy.
                                                FDA has verified the applicant’s claims                                                                         Submit electronic comments in the
                                                                                                        [FR Doc. 2018–02419 Filed 2–6–18; 8:45 am]
                                                that the date the investigational new                                                                         following way:
                                                drug application became effective was                   BILLING CODE 4164–01–P                                  • Federal eRulemaking Portal:
                                                on February 15, 2007.                                                                                         https://www.regulations.gov. Follow the
                                                   2. The date the application was                                                                            instructions for submitting comments.
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                                                initially submitted with respect to the                                                                       Comments submitted electronically,
                                                human biological product under section                                                                        including attachments, to https://
                                                351 of the Public Health Service Act (42                                                                      www.regulations.gov will be posted to
                                                U.S.C. 262): September 19, 2014. FDA                                                                          the docket unchanged. Because your
                                                has verified the applicant’s claim that                                                                       comment will be made public, you are
                                                the biologics license application (BLA)                                                                       solely responsible for ensuring that your
                                                for BLINCYTO (BLA 125557) was                                                                                 comment does not include any


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                                                5442                       Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices

                                                confidential information that you or a                  Staff. If you do not wish your name and               validity of the methodology and
                                                third party may not wish to be posted,                  contact information to be made publicly               assumptions used; (3) ways to enhance
                                                such as medical information, your or                    available, you can provide this                       the quality, utility, and clarity of the
                                                anyone else’s Social Security number, or                information on the cover sheet and not                information to be collected; and (4)
                                                confidential business information, such                 in the body of your comments and you                  ways to minimize the burden of the
                                                as a manufacturing process. Please note                 must identify this information as                     collection of information on
                                                that if you include your name, contact                  ‘‘confidential.’’ Any information marked              respondents, including through the use
                                                information, or other information that                  as ‘‘confidential’’ will not be disclosed             of automated collection techniques,
                                                identifies you in the body of your                      except in accordance with 21 CFR 10.20                when appropriate, and other forms of
                                                comments, that information will be                      and other applicable disclosure law. For              information technology.
                                                posted on https://www.regulations.gov.                  more information about FDA’s posting
                                                  • If you want to submit a comment                     of comments to public dockets, see 80                 Survey on the Occurrence of Foodborne
                                                with confidential information that you                  FR 56469, September 18, 2015, or access               Illness Risk Factors in Selected
                                                do not wish to be made available to the                 the information at: https://www.gpo.gov/              Institutional Foodservice and Retail
                                                public, submit the comment as a                         fdsys/pkg/FR-2015-09-18/pdf/2015-                     Food Stores Facility Types
                                                written/paper submission and in the                     23389.pdf.                                            OMB Control Number 0910–0799—
                                                manner detailed (see ‘‘Written/Paper                       Docket: For access to the docket to                Reinstatement
                                                Submissions’’ and ‘‘Instructions’’).                    read background documents or the
                                                                                                        electronic and written/paper comments                 I. Background
                                                Written/Paper Submissions
                                                                                                        received, go to https://                                 From 1998 to 2008, FDA’s National
                                                   Submit written/paper submissions as                  www.regulations.gov and insert the                    Retail Food Team conducted a study to
                                                follows:                                                docket number, found in brackets in the               measure trends in the occurrence of
                                                   • Mail/Hand delivery/Courier (for                    heading of this document, into the                    foodborne illness risk factors,
                                                written/paper submissions): Dockets                     ‘‘Search’’ box and follow the prompts                 preparation practices, and employee
                                                Management Staff (HFA–305), Food and                    and/or go to the Dockets Management                   behaviors most commonly reported to
                                                Drug Administration, 5630 Fishers                       Staff, 5630 Fishers Lane, Rm. 1061,                   the Centers for Disease Control and
                                                Lane, Rm. 1061, Rockville, MD 20852.                    Rockville, MD 20852.                                  Prevention as contributing factors to
                                                   • For written/paper comments
                                                                                                        FOR FURTHER INFORMATION CONTACT: Ila                  foodborne illness outbreaks at the retail
                                                submitted to the Dockets Management
                                                                                                        S. Mizrachi, Office of Operations, Food               level. Specifically, data was collected by
                                                Staff, FDA will post your comment, as
                                                                                                        and Drug Administration, Three White                  FDA specialists in retail and foodservice
                                                well as any attachments, except for
                                                                                                        Flint North, 10A–12M, 11601                           establishments at 5-year intervals (1998,
                                                information submitted, marked and
                                                                                                        Landsdown St., North Bethesda, MD                     2003, and 2008) to observe and
                                                identified, as confidential, if submitted
                                                                                                        20852, 301–796–7726, PRAStaff@                        document trends in the occurrence of
                                                as detailed in ‘‘Instructions.’’
                                                                                                        fda.hhs.gov.                                          the following foodborne illness risk
                                                   Instructions: All submissions received
                                                                                                                                                              factors:
                                                must include the Docket No. FDA–                        SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                                 • Food from Unsafe Sources,
                                                2018–N–0270 for ‘‘Survey on the                         PRA (44 U.S.C. 3501–3520), Federal                       • Poor Personal Hygiene,
                                                Occurrence of Foodborne Illness Risk                    Agencies must obtain approval from the                   • Inadequate Cooking,
                                                Factors in Selected Institutional                       Office of Management and Budget                          • Improper Holding/Time and
                                                Foodservice and Retail Food Stores                      (OMB) for each collection of                          Temperature, and
                                                Facility Types.’’ Received comments,                    information they conduct or sponsor.                     • Contaminated Equipment/Cross-
                                                those filed in a timely manner (see                     ‘‘Collection of information’’ is defined              Contamination.
                                                ADDRESSES), will be placed in the docket                in 44 U.S.C. 3502(3) and 5 CFR                           FDA developed reports summarizing
                                                and, except for those submitted as                      1320.3(c) and includes Agency requests                the findings for each of the three data
                                                ‘‘Confidential Submissions,’’ publicly                  or requirements that members of the                   collection periods (1998, 2003, and
                                                viewable at https://www.regulations.gov                 public submit reports, keep records, or               2008) (Refs. 1 to 3). Data from all three
                                                or at the Dockets Management Staff                      provide information to a third party.                 data collection periods were analyzed to
                                                between 9 a.m. and 4 p.m., Monday                       Section 3506(c)(2)(A) of the PRA (44                  detect trends in improvement or
                                                through Friday.                                         U.S.C. 3506(c)(2)(A)) requires Federal                regression over time and to determine
                                                   • Confidential Submissions—To                        Agencies to provide a 60-day notice in                whether progress had been made toward
                                                submit a comment with confidential                      the Federal Register concerning each                  the goal of reducing the occurrence of
                                                information that you do not wish to be                  proposed collection of information,                   foodborne illness risk factors in selected
                                                made publicly available, submit your                    including each proposed reinstatement                 retail and foodservice facility types (Ref.
                                                comments only as a written/paper                        of an existing collection of information              4).
                                                submission. You should submit two                       before submitting the collection to OMB                  Using this 10-year survey as a
                                                copies total. One copy will include the                 for approval. To comply with this                     foundation, in 2013–2014, FDA initiated
                                                information you claim to be confidential                requirement, FDA is publishing notice                 a new study in full service and fast food
                                                with a heading or cover note that states                of the proposed collection of                         restaurants. This study will span 10
                                                ‘‘THIS DOCUMENT CONTAINS                                information set forth in this document.               years with additional data collections
                                                CONFIDENTIAL INFORMATION.’’ The                            With respect to the following                      planned for 2017–2018 and 2021–2022.
                                                Agency will review this copy, including                 collection of information, FDA invites                   FDA recently completed the baseline
                                                the claimed confidential information, in                comments on these topics: (1) Whether                 data collection in select health care,
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                                                its consideration of comments. The                      the proposed collection of information                school, and retail food store facility
                                                second copy, which will have the                        is necessary for the proper performance               types in 2015–2016. This proposed
                                                claimed confidential information                        of FDA’s functions, including whether                 study will also span 10 years with
                                                redacted/blacked out, will be available                 the information will have practical                   additional data collections planned for
                                                for public viewing and posted on                        utility; (2) the accuracy of FDA’s                    2019–2020 (the subject of this
                                                https://www.regulations.gov. Submit                     estimate of the burden of the proposed                information collection request
                                                both copies to the Dockets Management                   collection of information, including the              reinstatement) and 2023–2024 (which


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                                                                              Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices                                             5443

                                                will be posted in the Federal Register at
                                                the next renewal).

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

                                                Health Care Facilities ...........     Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible popu-
                                                                                         lations as defined as follows:
                                                                                            • Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing meals
                                                                                              and transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals in the cafe-
                                                                                              teria may also be served to hospital staff and visitors).
                                                                                            • Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care liv-
                                                                                              ing setting such as nursing homes and assisted living facilities.
                                                                                       Note: For the purposes of this study, health care facilities that do not prepare or serve food to a highly suscep-
                                                                                         tible population, such as mental health care facilities, are not included in this facility type category.
                                                Schools (K–12) .....................   Foodservice operations that have the primary function of preparing and serving meals for students in one or more
                                                                                         grade levels from kindergarten through grade 12. A school foodservice may be part of a public or private insti-
                                                                                         tution.
                                                Retail Food Stores ...............     Supermarkets and grocery stores that have a deli department/operation as described as follows:
                                                                                            • Deli department/operation—Areas in a retail food store where foods, such as luncheon meats and
                                                                                              cheeses, are sliced for the customers and where sandwiches and salads are prepared onsite or received
                                                                                              from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include:
                                                                                                 • Salad bars, pizza stations, and other food bars managed by the deli department manager.
                                                                                                 • Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are man-
                                                                                                   aged by the deli department manager.
                                                                                       Data will also be collected in the following areas of a supermarket or grocery store, if present:
                                                                                            • Seafood department/operation—Areas in a retail food store where seafood is cut, prepared, stored, or dis-
                                                                                              played for sale to the consumer. In retail food stores where the seafood department is combined with an-
                                                                                              other department (e.g. meat), the data collector will only assess the procedures and practices associated
                                                                                              with the processing of seafood.
                                                                                            • Produce department/operation—Areas in a retail food store where produce is cut, prepared, stored, or dis-
                                                                                              played for sale to the consumer. A produce operation may include salad bars or juice stations that are
                                                                                              managed by the produce manager.



                                                   The purpose of the study is to:                          • Identify the least and most often                  within 5 percent of the true compliance
                                                   • Assist FDA with developing retail                    occurring foodborne illness risk factors               percentage.
                                                food safety initiatives and policies                      and food safety behaviors/practices in                    A geographical information system
                                                focused on the control of foodborne                       health care, school, restaurant, and                   database containing a listing of
                                                illness risk factors;                                     retail food store facility types during                businesses throughout the United States
                                                   • Identify retail food safety work plan                each data collection period;                           provides the establishment inventory for
                                                priorities and allocate resources to                        • Track improvement and/or                           the data collections. FDA samples
                                                enhance retail food safety nationwide;                    regression trends in the occurrence of                 establishments from the inventory based
                                                                                                          foodborne illness risk factors during the              on the descriptions in table 1. FDA does
                                                   • Track changes in the occurrence of
                                                                                                          10-year study period;                                  not intend to sample operations that
                                                foodborne illness risk factors in retail
                                                                                                            • Examine potential correlations                     handle only prepackaged food items or
                                                and foodservice establishments over
                                                                                                          between operational characteristics of                 conduct low-risk food preparation
                                                time; and
                                                                                                          food establishments and the control of                 activities. The ‘‘FDA Food Code’’
                                                   • Inform recommendations to the                                                                               contains a grouping of establishments
                                                retail and foodservice industry and                       foodborne illness risk factors;
                                                                                                                                                                 by risk, based on the type of food
                                                State, local, tribal, and territorial                       • Examine potential correlations                     preparation that is normally conducted
                                                regulatory professionals on reducing the                  between elements within regulatory                     within the operation (Ref. 5). The intent
                                                occurrence of foodborne illness risk                      retail food protection programs and the                is to sample establishments that fall
                                                factors.                                                  control of foodborne illness risk factors;             under risk categories 2 through 4.
                                                   The statutory basis for FDA                            and                                                       FDA has approximately 25 Regional
                                                conducting this study is derived from                       • Determine the extent to which food                 Retail Food Specialists (Specialists) who
                                                the Public Health Service Act (PHS Act)                   safety management systems and the                      serve as the data collectors for the 10-
                                                (42 U.S.C. 243, section 311(a)).                          presence of a certified food protection                year study. The Specialists are
                                                Responsibility for carrying out the                       manager impact the occurrence of                       geographically dispersed throughout the
                                                provisions of the PHS Act relative to                     foodborne illness risk factors.                        United States and possess technical
                                                food protection was transferred to the                      The methodology to be used for this                  expertise in retail food safety and a solid
                                                Commissioner of Food and Drugs in                         information collection is described as                 understanding of the operations within
                                                1968 (21 CFR 5.10(a)(2) and (4)).                         follows. To obtain a sufficient number                 each of the facility types to be surveyed.
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                                                Additionally, the Federal Food, Drug,                     of observations to conduct statistically               The Specialists are also standardized by
                                                and Cosmetic Act (21 U.S.C. 301 et seq.)                  significant analysis, FDA will conduct                 FDA’s Center for Food Safety and
                                                and the Economy Act (31 U.S.C. 1535)                      approximately 400 data collections in                  Applied Nutrition personnel in the
                                                require FDA to provide assistance to                      each facility type. This sample size has               application and interpretation of the
                                                other Federal, State, and local                           been calculated to provide for sufficient              FDA Food Code (Ref. 5).
                                                government bodies.                                        observations to be 95 percent confident                   Sampling zones have been established
                                                   The objectives of the study are to:                    that the compliance percentage is                      that are equal to the 150-mile radius


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                                                5444                       Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices

                                                around a Specialist’s home location.                    interview with the establishment owner                were made available for the data
                                                The sample is selected randomly from                    or person in charge by the Specialist                 collections were part of a broader
                                                among all eligible establishments                       and includes a standard set of questions.             Agency initiative focused on internal
                                                located within these sampling zones.                       The information in Section 2—                      uses of hand-held technology. The
                                                The Specialists are generally located in                ‘‘Regulatory Authority Information’’ is               tablets provided for the data collection
                                                major metropolitan areas (i.e.,                         obtained during an interview with the                 presented several technical and
                                                population centers) across the                          program director of the State or local                logistical challenges and increased the
                                                contiguous United States. Population                    jurisdiction that has regulatory                      time burden associated with the data
                                                centers usually contain a large                         responsibility for conducting                         collection as compared to the manual
                                                concentration of the establishments                     inspections for the selected                          entry of data collections. FDA continues
                                                FDA intends to sample. Sampling from                    establishment. Section 3 includes three               to assess the feasibility for fully
                                                the 150-mile radius sampling zones                      parts: Part A for tabulating the                      incorporating use of hand-held
                                                around the Specialists’ home locations                  Specialists’ observations of the food                 technology in subsequent data
                                                provides three advantages to the study:                 employees’ behaviors and practices in                 collections during the 10-year study
                                                   1. It provides a cross-section of urban              limiting contamination, proliferation,                period.
                                                and rural areas from which to sample                    and survival of food safety hazards; Part                When a data collector is assigned a
                                                the eligible establishments.                            B for assessing the food safety                       specific establishment, he or she
                                                   2. It represents a mix of small,                     management system being implemented                   conducts the data collection and enters
                                                medium, and large regulatory entities                   by the facility; and Part C for assessing             the information into the web-based data
                                                having jurisdiction over the eligible                   the frequency and extent of food                      platform. The interface will support the
                                                establishments.                                         employee hand washing. The                            manual entering of data, as well as the
                                                   3. It reduces overnight travel and                   information in Part A is collected from               ability to directly enter information in
                                                therefore reduces travel costs incurred                 the Specialists’ direct observations of               the database via a web browser.
                                                by the Agency to collect data.                          food employee behaviors and practices.                   The burden for the 2019–2020 data
                                                   The sample for each data collection                  Infrequent, nonstandard questions may                 collection is as follows. For each data
                                                period is evenly distributed among                      be asked by the Specialists if                        collection, the respondents will include:
                                                Specialists. Given that participation in                clarification is needed on the food safety            (1) The person in charge of the selected
                                                the study by industry is voluntary and                  procedure or practice being observed.                 facility (whether it be a health care
                                                the status of any given randomly                        The information in Part B is collected by             facility, school, or supermarket/grocery
                                                selected establishment is subject to                    making direct observations and asking                 store) and (2) the program director (or
                                                change, substitute establishments have                  follow up questions of facility                       designated individual) of the respective
                                                been selected for each Specialist for                   management to obtain information on                   regulatory authority. To provide the
                                                cases where the institutional                           the extent to which the food                          sufficient number of observations
                                                foodservice, school, or retail food store               establishment has developed and                       needed to conduct a statistically
                                                facility is misclassified, closed, or                   implemented food safety management                    significant analysis of the data, FDA has
                                                otherwise unavailable, unable, or                       systems. The information in Part C is                 determined that 400 data collections
                                                unwilling to participate.                               collected by making direct observations               will be required in each of the three
                                                   Prior to conducting the data                         of food employee hand washing. No                     facility types. Therefore, the total
                                                collection, Specialists contact the State               questions are asked in the completion of              number of responses will be 2,400 (400
                                                or local jurisdiction that has regulatory               Section 3, Part C of the form.                        data collections × 3 facility types × 2
                                                responsibility for conducting retail food                  FDA collects the following                         respondents per data collection).
                                                inspections for the selected                            information associated with the                          The burden associated with the
                                                establishment. The Specialist verifies                  establishment’s identity: Establishment               completion of Sections 1 and 3 of the
                                                with the jurisdiction that the facility has             name, street address, city, state, ZIP                form is specific to the persons in charge
                                                been properly classified for the                        code, county, industry segment, and                   of the selected facilities. It includes the
                                                purposes of the study and is still in                   facility type. The establishment                      time it will take the person in charge to
                                                operation. The Specialist ascertains                    identifying information is collected to               accompany the data collector during the
                                                whether the selected facility is under                  ensure the data collections are not                   site visit and answer the data collector’s
                                                legal notice from the State or local                    duplicative. Other information related                questions. The burden related to the
                                                regulatory authority. If the selected                   to the nature of the operation, such as               completion of Section 2 of the form is
                                                facility is under legal notice, the                     seating capacity and number of                        specific to the program directors (or
                                                Specialist will not conduct a data                      employees per shift, is also collected.               designated individuals) of the respective
                                                collection, and a substitute                            Data will be consolidated and reported                regulatory authorities. It includes the
                                                establishment will be used. An                          in a manner that does not reveal the                  time it will take to answer the data
                                                invitation is extended to the State or                  identity of any establishment included                collectors’ questions and is the same
                                                local regulatory authority to accompany                 in the study.                                         regardless of the facility type.
                                                the Specialist on the data collection                      FDA has collaborated with the Food                    To calculate the estimate of the hours
                                                visit.                                                  Protection and Defense Institute to                   per response, FDA uses the average data
                                                   A standard form is used by the                       develop a web-based platform in                       collection duration for similar facility
                                                Specialists during each data collection.                FoodSHIELD to collect, store, and                     types during the FDA’s 2008 Risk Factor
                                                The form is divided into three sections:                analyze data for the Retail Risk Factor               Study (Ref. 3) plus an additional 30
                                                Section 1—‘‘Establishment                               Study. This platform is accessible to                 minutes (0.5 hours) for the information
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                                                Information’’; Section 2—‘‘Regulatory                   State, local, territorial, and tribal                 related to Section 3, Part B of the form.
                                                Authority Information’’; and Section 3—                 regulatory jurisdictions to collect data              FDA estimates that it will take the
                                                ‘‘Foodborne Illness Risk Factor and                     relevant to their own risk factor studies.            persons in charge of health care facility
                                                Food Safety Management System                           For the 2015–2016 data collection, FDA                types, schools, and retail food stores 150
                                                Assessment’’. The information in                        piloted the use of hand-held technology               minutes (2.5 hours), 120 minutes (2
                                                Section 1—‘‘Establishment Information’’                 for capturing the data onsite during the              hours), and 180 minutes (3 hours),
                                                of the form is obtained during an                       data collection visits. The tablets that              respectively, to accompany the data


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                                                                                       Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices                                                                                                                             5445

                                                collectors while they complete Sections                                           estimate for a data collection in health                                                2 percent for the data collections within
                                                1 and 3 of the form. FDA estimates that                                           care facility types is 180 minutes (150                                                 health care, school, and retail food store
                                                it will take the program director (or                                             + 30) (3 hours), in schools is 150                                                      facility types. The estimate of the time
                                                designated individual) of the respective                                          minutes (120 + 30) (2.5 hours), and                                                     per non-respondent is 5 minutes (0.08
                                                regulatory authority 30 minutes (0.5                                              retail food stores is 210 minutes (180 +                                                hours) for the person in charge to listen
                                                hours) to answer the questions related to                                         30) (3.5 hours).                                                                        to the purpose of the visit and provide
                                                Section 2 of the form. This burden                                                  Based on the number of entry refusals                                                 a verbal refusal of entry.
                                                estimate is unchanged from the last data                                          from the 2015–2016 baseline data                                                          FDA estimates the burden of this
                                                collection. Hence, the total burden                                               collection, we estimate a refusal rate of                                               collection of information as follows:
                                                                                                                   TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                        Number of                                                             Number of
                                                                                                                                                                                        Number of                                    Total annual                   Average
                                                                                                                  Number of              responses              Total annual                                   responses                                                                      Total
                                                                        Activity                                                                                                           non-                                          non-                     burden per
                                                                                                                 respondents                per                  responses                                      per non-                                                                      hours
                                                                                                                                                                                       respondents                                    responses                    response
                                                                                                                                        respondent                                                            respondent

                                                2019–2020 Data Collection (Health Care                                         400                       1                    400      ....................   ....................   ....................   2.5 ........................        1,000
                                                  Facilities)—Completion of Sections 1
                                                  and 3.
                                                2019–2020 Data Collection (Schools)—                                           400                       1                    400      ....................   ....................   ....................   2 ...........................         800
                                                  Completion of Sections 1 and 3.
                                                2019–2020 Data Collection (Retail Food                                         400                       1                    400      ....................   ....................   ....................   3 ...........................       1,200
                                                  Stores)—Completion of Sections 1 and
                                                  3.
                                                2019–2020 Data Collection-Completion of                                     1,200                        1                1,200        ....................   ....................   ....................   .5 (30 minutes) .....                 600
                                                  Section 2—All Facility Types.
                                                2019–2020 Data Collection-Entry Refus-                           ....................   ....................    ....................                   24                      1                     24     .08 (5 minutes) .....                1.92
                                                  als—All Facility Types.

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


                                                  The burden for this information                                                       20170406023004/https://www.fda.gov/                                               Group, Microbiology and Infectious
                                                collection has not changed since the last                                               Food/GuidanceRegulation/RetailFood                                                Diseases Research Committee.
                                                OMB approval.                                                                           Protection/FoodborneIllnessRiskFactor
                                                                                                                                        Reduction/ucm224321.htm.                                                            The meeting will be closed to the
                                                II. References                                                                    4. FDA National Retail Food Team. ‘‘FDA                                                 public in accordance with the
                                                   The following references are on
                                                                                                                                        Trend Analysis Report on the                                                      provisions set forth in sections
                                                                                                                                        Occurrence of Foodborne Illness Risk                                              552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                display in the Dockets Management                                                       Factors in Selected Institutional
                                                Staff (see ADDRESSES) and are available                                                                                                                                   as amended. The grant applications and
                                                                                                                                        Foodservice, Restaurant, and Retail Food
                                                for viewing by interested persons                                                       Store Facility Types (1998–2008).’’
                                                                                                                                                                                                                          the discussions could disclose
                                                between 9 a.m. and 4 p.m., Monday                                                       Available at: https://wayback.archive-                                            confidential trade secrets or commercial
                                                through Friday; they are also available                                                 it.org/7993/20170406022950/https://                                               property such as patentable material,
                                                electronically at https://                                                              www.fda.gov/Food/GuidanceRegulation/                                              and personal information concerning
                                                www.regulations.gov. FDA has verified                                                   RetailFoodProtection/Foodborne                                                    individuals associated with the grant
                                                                                                                                        IllnessRiskFactorReduction/                                                       applications, the disclosure of which
                                                the website addresses, as of the date this                                              ucm223293.htm.
                                                document publishes in the Federal                                                                                                                                         would constitute a clearly unwarranted
                                                                                                                                  5. ‘‘FDA Food Code.’’ Available at: https://
                                                Register, but websites are subject to                                                   www.fda.gov/Food/GuidanceRegulation/                                              invasion of personal privacy.
                                                change over time.                                                                       RetailFoodProtection/FoodCode/                                                      Name of Committee: Microbiology,
                                                1. ‘‘Report of the FDA Retail Food Program                                              default.htm.                                                                      Infectious Diseases and AIDS Initial Review
                                                      Database of Foodborne Illness Risk                                            Dated: January 31, 2018.                                                              Group; Microbiology and Infectious Diseases
                                                      Factors’’ (2000). Available at: https://                                    Leslie Kux,                                                                             Research Committee.
                                                      wayback.archive-it.org/7993/201704                                                                                                                                    Date: March 1–2, 2018.
                                                                                                                                  Associate Commissioner for Policy.
                                                      06023019/https://www.fda.gov/                                                                                                                                         Time: 8:00 a.m. to 5:00 p.m.
                                                      downloads/Food/GuidanceRegulation/                                          [FR Doc. 2018–02413 Filed 2–6–18; 8:45 am]
                                                                                                                                                                                                                            Agenda: To review and evaluate grant
                                                      UCM123546.pdf.                                                              BILLING CODE 4164–01–P
                                                                                                                                                                                                                          applications.
                                                2. ‘‘FDA Report on the Occurrence of
                                                                                                                                                                                                                            Place: National Institutes of Health, 5601
                                                      Foodborne Illness Risk Factors in
                                                      Selected Institutional Foodservice,                                                                                                                                 Fishers Lane, Rockville, MD 20892
                                                                                                                                  DEPARTMENT OF HEALTH AND
                                                      Restaurant, and Retail Food Store                                                                                                                                   (Telephone Conference Call).
                                                                                                                                  HUMAN SERVICES
                                                      Facility Types’’ (2004). Available at:                                                                                                                                Contact Person: Frank S. De Silva, Ph.D.,
                                                      https://wayback.archive-it.org/7993/                                        National Institutes of Health                                                           Scientific Review Officer, Scientific Review
                                                      20170406023011/https://www.fda.gov/                                                                                                                                 Program, Division of Extramural Activities,
                                                      downloads/Food/GuidanceRegulation/                                          National Institute of Allergy and                                                       Room #3E72A, National Institutes of Health/
                                                      RetailFoodProtection/Foodborne                                                                                                                                      NIAID, 5601 Fishers Lane, MSC 9834,
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                                  Infectious Diseases; Notice of Closed
                                                      IllnessRiskFactorReduction/                                                 Meeting                                                                                 Bethesda, MD 20892–934, (240) 669–5023,
                                                      UCM423850.pdf.                                                                                                                                                      fdesilva@niaid.nih.gov.
                                                3. ‘‘FDA Report on the Occurrence of
                                                      Foodborne Illness Risk Factors in
                                                                                                                                    Pursuant to section 10(d) of the                                                      (Catalogue of Federal Domestic Assistance
                                                      Selected Institutional Foodservice,                                         Federal Advisory Committee Act, as                                                      Program Nos. 93.855, Allergy, Immunology,
                                                      Restaurant, and Retail Food Store                                           amended, notice is hereby given of a                                                    and Transplantation Research; 93.856,
                                                      Facility Types’’ (2009). Available at:                                      meeting of the Microbiology, Infectious                                                 Microbiology and Infectious Diseases
                                                      https://wayback.archive-it.org/7993/                                        Diseases and AIDS Initial Review                                                        Research, National Institutes of Health, HHS)



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Document Created: 2018-10-26 13:56:16
Document Modified: 2018-10-26 13:56:16
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.
DatesSubmit either electronic or written comments on the collection of information by April 9, 2018.
ContactIla S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation83 FR 5441 

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