Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types, 36594-36598 [2018-16189]
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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
priorities, standards, budget requests,
and assistance policies. ORR regulations
require that State Refugee Resettlement
and Wilson-Fish agencies, and local and
Tribal governments complete Form
ORR–6 in order to participate in the
above-mentioned programs.
Respondents: State governments,
Replacement Designees, and Wilson/
Fish Alternative Projects.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Total burden
hours
ORR–6 Performance Report ...........................................................................
59
2
15
1,770
Estimated Total Annual Burden
Hours: 1,770.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–15987 Filed 7–27–18; 8:45 am]
BILLING CODE 4184–45–P
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 29,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0744. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
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.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2012–N–0547]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Retail and
Foodservice Facility Types
AGENCY:
Food and Drug Administration,
HHS.
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Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Retail
and Foodservice Facility Types
OMB Control Number 0910–0744—
Extension
I. Background
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 to 2014 FDA
initiated a new study in full service and
fast food restaurants. This study will
span 10 years with a data collection
currently being conducted in 2017 to
2018 and another data collection
planned for 2021 to 2022 (the subject of
this information collection request
extension).
From 1998 to 2008, FDA’s National
Retail Food Team conducted a study to
measure trends in the occurrence of
foodborne illness risk factors,
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TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
Facility type
Description
Full Service Restaurants ......
A restaurant where customers place their order at their table, are served their meal at the table, receive the service of the wait staff, and pay at the end of the meal.
A restaurant that is not a full service restaurant. This includes restaurants commonly referred to as quick service
restaurants and fast casual restaurants.
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Fast Food Restaurants ........
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 (FD&C 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
retail and foodservice 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
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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 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
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:
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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 restaurant 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
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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
followup 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 to 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
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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 2021 to 2022 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 fast food or full
service restaurant) 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 two restaurant facility types.
Therefore, the total number of responses
will be 1,600 (400 data collections × 2
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.
In the Federal Register of February 7,
2018 (83 FR 5433), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received two
comments.
(Comment 1) We received comments
related to FDA’s authority for
collaboration with State and local
governments regarding food safety at the
retail level.
(Response 1) The statutory basis for
FDA conducting this survey is the PHS
Act, which requires that FDA provide
assistance to State and local
governments relative to the prevention
and suppression of communicable
diseases. Responsibility for carrying out
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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 FD&C 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.
(Comment 2) The Academy of
Nutrition and Dietetics (the Academy)
commented that they support the
proposed information collection for the
survey on the occurrence of foodborne
illness risk factors in various settings.
The Academy provided comments
pertaining to the following general areas
of the study:
a. Question as to whether 90 minutes
is adequate for surveying larger
facilities.
b. Request FDA evaluate the impact of
conducting surveys during non-peak
hours of operation.
c. Suggest that the use of gloves is not
adequately addressed in the survey.
d. Recommend adding a food allergy
component.
e. Encourage continued efforts to
simplify and standardize expiration
dates.
Related to foodservice operations at
the retail level, the Academy provided
the following comments:
a. Suggest that FDA consider
conducting the survey by using local
inspectors who already inspect facilities
for other purposes.
b. Suggest that educational efforts
should be culturally guided, provided in
multiple languages, and include photos
or illustrations to facilitate remediation.
c. FDA consider modifying the survey
to account for new foods and new
means of conveying food.
(Response 2) FDA thanks the
submitter for their comments and
appreciates their support. Regarding
general areas of the study, FDA provides
the following responses:
a. The current 10-year study estimates
90 minutes as the average time needed
to adequately collect necessary
information, taking into account both
small and large facilities. This average
time is consistent with the amount of
time burden estimated for the previous
data collection periods and provides a
sufficient timeframe to observe food
safety practices and procedures that are
the focus of the study.
b. Based on the methodology of the
study, the information collection is
performed during hours of operation of
the randomly selected facility. Data
collections are scheduled at times that
provide the best opportunity to observe
food preparation activities.
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c. Information collection related to
handwashing and no bare hand contact
with ready to eat foods, which may
include use of gloves, is based on
assessment of observations against the
most current addition of the FDA Model
Food Code. Provisions of the FDA Food
Code identify when handwashing and
no bare hand contact with ready to eat
food are required during food
preparation and service. The current
FDA Food Code does not recognize the
use of hand antiseptics in lieu of
handwashing during food preparation
and service.
d. The study is collecting information
regarding the knowledge of the person
in charge related to food allergens and
training of food service employees on
allergy awareness as it relates to their
assigned duties in their facility.
e. The scope of this data collection
focuses on foodborne illness risk factors
and does not include assessment of
expiration dates of manufactured foods
as part of this research assessment.
Related to foodservice operations at
the retail level, FDA provides the
following responses:
a. This type of research requires a
standardized design and methodology to
ensure that the occurrences of the
foodborne illness risk factors are
uniformly assessed. Retail Food
Specialists are standardized by Center
for Food Safety and Applied Nutrition
and have a strong working knowledge of
retail food industry. State and local
regulators are encouraged to accompany
the data collectors during the data
collection.
b. The research from this study
facilitates the development of culturally
guided, multi-language education
outreach materials that can be shared
with regulatory and industry partners.
c. The study design accounts for a
variety of food conveyances in the retail
food setting. The study includes four
major segments of the retail and
foodservice industries that account for
over a million varied and diverse types
of operations in the United States:
• Restaurants
• Healthcare Facilities
• Schools (K–12)
• Retail Food Stores
To calculate the estimate of the hours
per response, FDA will use the average
data collection duration for the same
facility types during the 2013 to 2014
data collection. FDA estimates that it
will take the persons in charge of full
service restaurants and fast food
restaurants 104 minutes (1.73 hours)
and 82 minutes (1.36 hours),
respectively, to accompany the data
collectors while they complete Sections
1 and 3 of the form. In comparison, for
the 2013 to 2014 data collection, the
burden estimate was 106 minutes (1.76
hours) in full service restaurants and 73
minutes (1.21 hours) in fast food
restaurants. FDA estimates that it will
take the program director (or designated
individual) of the respective regulatory
authority 30 minutes (0.5 hours) to
answer the questions related to Section
2 of the form. This burden estimate is
unchanged from the last data collection.
Hence, the total burden estimate for a
data collection in a full service
restaurant, including the responses of
both the program director and the
person in charge, is 134 minutes (104 +
30) (2.23 hours). The total burden
estimate for a data collection in a fast
food restaurant, including the responses
of both the program director and the
person in charge, is 112 minutes (82 +
30) (1.86 hours).
Based on the number of entry refusals
from the 2013 to 2014 baseline data
collection, we estimate a refusal rate of
2 percent for the data collections within
restaurant 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
2021–2022 Data Collection (Fast Food
Restaurants)—Completion of Sections
1 and 3.
2021–2022 Data Collection (Full Service
Restaurants)—Completion of Sections
1 and 3.
2021–2022 Data Collection-Completion of
Section 2—All Facility Types.
2021–2022 Data Collection-Entry Refusals—All Facility Types.
Total Hours .........................................
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
....................
....................
....................
1.36 ...................
544
400
1
400
....................
....................
....................
1.73 ...................
692
800
1
800
....................
....................
....................
0.5 (30 minutes)
400
....................
....................
....................
16
1
16
0.08 (5 minutes)
1.28
....................
....................
....................
....................
....................
....................
...........................
1,637.28
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
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Number of
responses
per
respondent
The following references are on
display in the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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
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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/7993/201704
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
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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/
20170406023004/https://www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/
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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.archiveit.org/7993/20170406022950/https://
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/FoodborneIllness
RiskFactorReduction/ucm223293.htm.
5. ‘‘FDA Food Code.’’ Available at: https://
www.fda.gov/FoodCode.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16189 Filed 7–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Medical Device User Fee Rates for
Fiscal Year 2019
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2019. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Medical Device User Fee
Amendments of 2017 (MDUFA IV),
authorizes FDA to collect user fees for
certain medical device submissions and
annual fees both for certain periodic
reports and for establishments subject to
registration. This notice establishes the
fee rates for FY 2019, which apply from
October 1, 2018, through September 30,
2019. To avoid delay in the review of
your application, you should pay the
application fee before or at the time you
submit your application to FDA. The fee
you must pay is the fee that is in effect
on the later of the date that your
application is received by FDA or the
date your fee payment is recognized by
the U.S. Treasury. If you want to pay a
reduced small business fee, you must
qualify as a small business before
making your submission to FDA; if you
do not qualify as a small business before
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SUMMARY:
making your submission to FDA, you
will have to pay the higher standard fee.
Please note that the establishment
registration fee is not eligible for a
reduced small business fee. As a result,
if the establishment registration fee is
the only medical device user fee that
you will pay in FY 2019, you should not
submit a Small Business Certification
Request. This document provides
information on how the fees for FY 2019
were determined, the payment
procedures you should follow, and how
you may qualify for reduced small
business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device
User Fees: Visit FDA’s website at:
https://www.fda.gov/ForIndustry/
UserFees/MedicalDeviceUserFee/
ucm20081521.htm.
For questions relating to the MDUFA
Small Business Program, please visit
CDRH’s website: https://www.fda.gov/
medicaldevices/deviceregulation
andguidance/howtomarketyourdevice/
premarketsubmissions/ucm577696.htm.
For questions relating to this notice:
David Haas, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.
(COLE–14202I), Silver Spring, MD
20993–0002, 240–402–9845.
SUPPLEMENTARY INFORMATION:
by FDA during FY 2019 is $300,000.
From this starting point, this document
establishes FY 2019 fee rates for certain
types of submissions, and for periodic
reporting, by applying criteria specified
in the FD&C Act.
The FD&C Act specifies the base fee
for establishment registration for each
year from FY 2018 through FY 2022; the
base fee for an establishment
registration in FY 2019 is $4,548. There
is no reduction in the registration fee for
small businesses. Each establishment
that is registered (or is required to
register) with the Secretary of Health
and Human Services under section 510
of the FD&C Act (21 U.S.C. 360) because
such establishment is engaged in the
manufacture, preparation, propagation,
compounding, or processing of a device
is required to pay the annual fee for
establishment registration.
I. Background
MDUFA specifies that the
$190,654,875 is to be adjusted for
inflation increases for FY 2019 using
two separate adjustments—one for
payroll costs and one for non-payroll
costs (see 21 U.S.C. 379j(c)(2)). The base
inflation adjustment for FY 2019 is the
sum of one plus these two separate
adjustments, and is compounded as
specified in the statute (see 21 U.S.C.
379j(c)(2)(C) and 379j(c)(2)(B)).
The component of the inflation
adjustment for payroll costs is the
average annual percent change in the
cost of all personnel compensation and
benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the
first 3 of the 4 preceding FYs,
multiplied by 0.60, or 60 percent (see 21
U.S.C. 379j(c)(2)(C)).
Table 1 summarizes the actual cost
and FTE data for the specified FYs, and
provides the percent change from the
previous FY and the average percent
change over the first 3 of the 4 FYs
preceding FY 2019. The 3-year average
is 2.4152 percent (rounded).
Section 738 of the FD&C Act (21
U.S.C. 379j) establishes fees for certain
medical device applications,
submissions, supplements, notices, and
requests (for simplicity, this document
refers to these collectively as
‘‘submissions’’ or ‘‘applications’’); for
periodic reporting on class III devices;
and for the registration of certain
establishments. Under statutorily
defined conditions, a qualified
applicant may receive a fee waiver or
may pay a lower small business fee (see
21 U.S.C. 379j(d) and (e)).
Under the FD&C Act, the fee rate for
each type of submission is set at a
specified percentage of the standard fee
for a premarket application (a premarket
application is a premarket approval
application (PMA), a product
development protocol (PDP), or a
biologics license application (BLA)).
The FD&C Act specifies the base fee for
a premarket application for each year
from FY 2018 through FY 2022; the base
fee for a premarket application received
II. Revenue Amount for FY 2019
The total revenue amount for FY 2019
is $190,654,875, as set forth in the
statute prior to the inflation adjustment
(see 21 U.S.C. 379j(b)(3)). MDUFA
directs FDA to use the yearly total
revenue amount as a starting point to set
the standard fee rates for each fee type.
The fee calculations for FY 2019 are
described in this document.
Inflation Adjustment
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year
2015
2016
2017
3-Year average
Total PC&B ..............................................................................................
$2,232,304,000
$2,414,728,159
$2,581,551,000
..........................
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]]>Agencies
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36594-36598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16189]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0547]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Retail and
Foodservice Facility Types
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
29, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0744.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Retail and Foodservice Facility Types
OMB Control Number 0910-0744--Extension
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 to 2014 FDA
initiated a new study in full service and fast food restaurants. This
study will span 10 years with a data collection currently being
conducted in 2017 to 2018 and another data collection planned for 2021
to 2022 (the subject of this information collection request extension).
[[Page 36595]]
Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
Facility type Description
------------------------------------------------------------------------
Full Service Restaurants..... A restaurant where customers place their
order at their table, are served their
meal at the table, receive the service
of the wait staff, and pay at the end of
the meal.
Fast Food Restaurants........ A restaurant that is not a full service
restaurant. This includes restaurants
commonly referred to as quick service
restaurants and fast casual restaurants.
------------------------------------------------------------------------
The 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 (FD&C 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 retail and
foodservice 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 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 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 restaurant 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
[[Page 36596]]
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 followup 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 to 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 2021 to 2022 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 fast food or full
service restaurant) 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 two restaurant facility
types. Therefore, the total number of responses will be 1,600 (400 data
collections x 2 facility types x 2 respondents per data collection).
The burden associated with the completion of Sections 1 and 3 of
the form is specific to the 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.
In the Federal Register of February 7, 2018 (83 FR 5433), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments.
(Comment 1) We received comments related to FDA's authority for
collaboration with State and local governments regarding food safety at
the retail level.
(Response 1) The statutory basis for FDA conducting this survey is
the PHS Act, which requires that FDA provide assistance to State and
local governments relative to the prevention and suppression of
communicable diseases. 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 FD&C 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.
(Comment 2) The Academy of Nutrition and Dietetics (the Academy)
commented that they support the proposed information collection for the
survey on the occurrence of foodborne illness risk factors in various
settings. The Academy provided comments pertaining to the following
general areas of the study:
a. Question as to whether 90 minutes is adequate for surveying
larger facilities.
b. Request FDA evaluate the impact of conducting surveys during
non-peak hours of operation.
c. Suggest that the use of gloves is not adequately addressed in
the survey.
d. Recommend adding a food allergy component.
e. Encourage continued efforts to simplify and standardize
expiration dates.
Related to foodservice operations at the retail level, the Academy
provided the following comments:
a. Suggest that FDA consider conducting the survey by using local
inspectors who already inspect facilities for other purposes.
b. Suggest that educational efforts should be culturally guided,
provided in multiple languages, and include photos or illustrations to
facilitate remediation.
c. FDA consider modifying the survey to account for new foods and
new means of conveying food.
(Response 2) FDA thanks the submitter for their comments and
appreciates their support. Regarding general areas of the study, FDA
provides the following responses:
a. The current 10-year study estimates 90 minutes as the average
time needed to adequately collect necessary information, taking into
account both small and large facilities. This average time is
consistent with the amount of time burden estimated for the previous
data collection periods and provides a sufficient timeframe to observe
food safety practices and procedures that are the focus of the study.
b. Based on the methodology of the study, the information
collection is performed during hours of operation of the randomly
selected facility. Data collections are scheduled at times that provide
the best opportunity to observe food preparation activities.
[[Page 36597]]
c. Information collection related to handwashing and no bare hand
contact with ready to eat foods, which may include use of gloves, is
based on assessment of observations against the most current addition
of the FDA Model Food Code. Provisions of the FDA Food Code identify
when handwashing and no bare hand contact with ready to eat food are
required during food preparation and service. The current FDA Food Code
does not recognize the use of hand antiseptics in lieu of handwashing
during food preparation and service.
d. The study is collecting information regarding the knowledge of
the person in charge related to food allergens and training of food
service employees on allergy awareness as it relates to their assigned
duties in their facility.
e. The scope of this data collection focuses on foodborne illness
risk factors and does not include assessment of expiration dates of
manufactured foods as part of this research assessment.
Related to foodservice operations at the retail level, FDA provides
the following responses:
a. This type of research requires a standardized design and
methodology to ensure that the occurrences of the foodborne illness
risk factors are uniformly assessed. Retail Food Specialists are
standardized by Center for Food Safety and Applied Nutrition and have a
strong working knowledge of retail food industry. State and local
regulators are encouraged to accompany the data collectors during the
data collection.
b. The research from this study facilitates the development of
culturally guided, multi-language education outreach materials that can
be shared with regulatory and industry partners.
c. The study design accounts for a variety of food conveyances in
the retail food setting. The study includes four major segments of the
retail and foodservice industries that account for over a million
varied and diverse types of operations in the United States:
Restaurants
Healthcare Facilities
Schools (K-12)
Retail Food Stores
To calculate the estimate of the hours per response, FDA will use
the average data collection duration for the same facility types during
the 2013 to 2014 data collection. FDA estimates that it will take the
persons in charge of full service restaurants and fast food restaurants
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to
accompany the data collectors while they complete Sections 1 and 3 of
the form. In comparison, for the 2013 to 2014 data collection, the
burden estimate was 106 minutes (1.76 hours) in full service
restaurants and 73 minutes (1.21 hours) in fast food restaurants. FDA
estimates that it will take the program director (or designated
individual) of the respective regulatory authority 30 minutes (0.5
hours) to answer the questions related to Section 2 of the form. This
burden estimate is unchanged from the last data collection. Hence, the
total burden estimate for a data collection in a full service
restaurant, including the responses of both the program director and
the person in charge, is 134 minutes (104 + 30) (2.23 hours). The total
burden estimate for a data collection in a fast food restaurant,
including the responses of both the program director and the person in
charge, is 112 minutes (82 + 30) (1.86 hours).
Based on the number of entry refusals from the 2013 to 2014
baseline data collection, we estimate a refusal rate of 2 percent for
the data collections within restaurant 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
Activity respondents per annual non- per non- annual non- response Total hours
respondent responses respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
2021-2022 Data Collection (Fast 400 1 400 ........... ........... ........... 1.36.................... 544
Food Restaurants)--Completion of
Sections 1 and 3.
2021-2022 Data Collection (Full 400 1 400 ........... ........... ........... 1.73.................... 692
Service Restaurants)--Completion
of Sections 1 and 3.
2021-2022 Data Collection- 800 1 800 ........... ........... ........... 0.5 (30 minutes)........ 400
Completion of Section 2--All
Facility Types.
2021-2022 Data Collection-Entry ........... ........... ........... 16 1 16 0.08 (5 minutes)........ 1.28
Refusals--All Facility Types.
--------------------------------------------------------------------------------------------------------------------
Total Hours.................... ........... ........... ........... ........... ........... ........... ........................ 1,637.28
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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/
[[Page 36598]]
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/FoodCode.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16189 Filed 7-27-18; 8:45 am]
BILLING CODE 4164-01-P
