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, 5441-5445 [2018-02413]
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product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product BLINCYTO
(blinatumomab). BLINCYTO is
indicated for the treatment of
Philadelphia chromosome-negative
relapsed or refractory B-cell precuror
acute lymphoblastic leukemia. This
indication is approved under
accelerated approval. Continued
approval for this indication may be
contingent upon verification of clinical
benefit in subsequent trials. Subsequent
to this approval, the USPTO received
patent term restoration applications for
BLINCYTO (U.S. Patent Nos. 7,112,324
and 8,007,796) from Amgen Research
(Munich) GMBH, and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
October 30, 2015, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
BLINCYTO represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
BLINCYTO is 2,850 days. Of this time,
2,774 days occurred during the testing
phase of the regulatory review period,
while 76 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: February 15, 2007.
FDA has verified the applicant’s claims
that the date the investigational new
drug application became effective was
on February 15, 2007.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): September 19, 2014. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for BLINCYTO (BLA 125557) was
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initially submitted on September 19,
2014.
3. The date the application was
approved: December 3, 2014. FDA has
verified the applicant’s claim that BLA
125557 was approved on December 3,
2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,462 or 432 days
of patent term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02419 Filed 2–6–18; 8:45 am]
BILLING CODE 4164–01–P
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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.
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.
SUMMARY:
III. Petitions
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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
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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
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
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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/CrossContamination.
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
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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.
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.
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.
Schools (K–12) .....................
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Retail Food Stores ...............
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:
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• 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
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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 10year 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
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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
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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
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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 × 3 facility types × 2
respondents per data collection).
The burden associated with the
completion of Sections 1 and 3 of the
form is specific to the 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
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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
respondents
Activity
2019–2020 Data Collection (Health Care
Facilities)—Completion of Sections 1
and 3.
2019–2020 Data Collection (Schools)—
Completion of Sections 1 and 3.
2019–2020 Data Collection (Retail Food
Stores)—Completion of Sections 1 and
3.
2019–2020 Data Collection-Completion of
Section 2—All Facility Types.
2019–2020 Data Collection-Entry Refusals—All Facility Types.
Total ....................................................
1 There
Total annual
responses
Number of
nonrespondents
Number of
responses
per nonrespondent
Total annual
nonresponses
Average
burden per
response
Total
hours
400
1
400
....................
....................
....................
2.5 ........................
1,000
400
1
400
....................
....................
....................
2 ...........................
800
400
1
400
....................
....................
....................
3 ...........................
1,200
1,200
1
1,200
....................
....................
....................
.5 (30 minutes) .....
600
....................
....................
....................
24
1
24
.08 (5 minutes) .....
1.92
....................
....................
....................
....................
....................
....................
...............................
3,601.92
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.
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses
per
respondent
1. ‘‘Report of the FDA Retail Food Program
Database of Foodborne Illness Risk
Factors’’ (2000). Available at: https://
wayback.archive-it.org/7993/201704
06023019/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/Foodborne
IllnessRiskFactorReduction/
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/
VerDate Sep<11>2014
18:17 Feb 06, 2018
Jkt 244001
20170406023004/https://www.fda.gov/
Food/GuidanceRegulation/RetailFood
Protection/FoodborneIllnessRiskFactor
Reduction/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.archiveit.org/7993/20170406022950/https://
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/Foodborne
IllnessRiskFactorReduction/
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Microbiology, Infectious
Diseases and AIDS Initial Review
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Group, Microbiology and Infectious
Diseases Research Committee.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
Research Committee.
Date: March 1–2, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Frank S. De Silva, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room #3E72A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9834,
Bethesda, MD 20892–934, (240) 669–5023,
fdesilva@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5441-5445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02413]
-----------------------------------------------------------------------
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.gpo.gov/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,
[email protected].
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
