Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013-2022), 36544-36548 [2012-14850]
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Federal Register / Vol. 77, No. 118 / Tuesday, June 19, 2012 / Notices
hazards to which they may be exposed;
(2) Relative symptoms and appropriate
emergency treatment; and (3) Proper
conditions and precautions for safe use
and exposure.
B. Annual Reporting Burden
Respondents: 563.
Responses per Respondent: 3.
Hours per Response: .658.
Total Burden Hours: 1111.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat, 1275 First Street
NE., Washington, DC 20417, telephone
(202) 501–4755. Please cite OMB
Control No. 3090–0205, Environmental
Conservation, Occupational Safety, and
Drug-Free Workplace, in all
correspondence.
Dated: June 11, 2012.
Joseph A. Neurauter,
Director, Office of Acquisition Policy, Senior
Procurement Executive.
[FR Doc. 2012–14836 Filed 6–18–12; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0547]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Retail and
Foodservice Facility Types (2013–
2022)
ACTION:
The meeting announced below
concerns Coordinating Center for
Research and Training to Promote the
Health of People with Developmental
and Other Disabilities, FOA DD12–006,
initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 11:00 a.m.–3:00 p.m., July
10, 2012 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Coordinating Center for
Research and Training to Promote the Health
of People with Developmental and Other
Disabilities, FOA DD12–006, initial review.’’
Contact Person for More Information:
M. Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Jkt 226001
[FR Doc. 2012–14922 Filed 6–18–12; 8:45 am]
Food and Drug Administration,
HHS.
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
16:39 Jun 18, 2012
Dated: June 13, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
AGENCY:
Centers for Disease Control and
Prevention
VerDate Mar<15>2010
Mailstop F–46, Atlanta, Georgia 30341,
Telephone: (770) 488–3585.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a survey entitled ‘‘Occurrence of
Foodborne Illness Risk Factors in
Selected Retail and Foodservice Facility
Types (2013–2022).’’
DATES: Submit written or electronic
comments on the collection of
information by August 20, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
SUMMARY:
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Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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
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.
FOR FURTHER INFORMATION CONTACT:
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Retail
and Foodservice Facility Types (2013–
2022)—(OMB Control Number 0910–
NEW)
I. Background
In 1998, the U.S. Food and Drug
Administration’s National Retail Food
Team initiated a 10-year voluntary
survey 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 (CDC) as
contributing factors to foodborne illness
outbreaks at the retail level.
Specifically, the survey included data
collection inspections of various types
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of retail and foodservice establishments
at 5-year intervals (1998, 2003, and
2008) in order 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.
• Contaminated Equipment/
Protection from Contamination.
FDA developed reports summarizing
the findings for each of the three data
collection periods (1998, 2003, and
2008) (Refs. 1–3). 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).
The research obtained from these
studies provides FDA a solid foundation
for developing a national retail food
program model that can be used by
Federal, state, local, and tribal agencies
to:
• Identify essential food safety
program performance measurements;
• Assess strengths and gaps in the
design, structure, and delivery of
program services;
• Establish program priorities and
intervention strategies focused on
reducing the occurrence of foodborne
illness risk factors; and
• Create a mechanism that justifies
program resources and allocates them to
program areas that will provide the most
significant public health benefits.
Using this 10-year survey as a
foundation, FDA is proposing to
conduct a new voluntary survey
encompassing annual data collections
over a 10-year period. The survey will
determine the following for each facility
type included in the study:
• The foodborne illness risk factors
that are in most need of priority
attention during each data collection
period;
• Trends of improvement or
regression in foodborne illness risk
factor occurrence over time; and
• The impact of industry food safety
management systems in controlling the
occurrence of foodborne illness risk
factors.
The results of the proposed study will
be used to:
• Formulate Agency retail food safety
policies and initiatives;
• Identify retail food work plan
priorities and allocate resources to
enhance retail food safety nationwide;
• Generate nationally representative
estimates of the prevalence of foodborne
illness risk factors and trends of
improvement and regression over time;
and
• Recommend best practices and
targeted intervention strategies to assist
the retail and foodservice industry and
state, local, and tribal regulators with
reducing foodborne illness risk factors.
The statutory basis for FDA
conducting this survey is the Public
Health Service Act (the PHS Act) (42
U.S.C. 243, section 311(a)) (Also 21 CFR
5.10(a)(2) and (4)), which requires that
FDA provide assistance to state and
local governments relative to the
prevention and suppression of
communicable diseases. In addition, the
PHS Act requires that FDA cooperate
with and aid state and local authorities
in the enforcement of their health
regulations and provide advice on
matters relating to the preservation and
improvement of public health.
Additionally, the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301) and
Economy Act (31 U.S.C. 1535) require
that FDA provide assistance to other
Federal, state, and local governmental
bodies.
In 2012, FDA will conduct a pilot data
collection to practice the use of the data
collection form and methods and test
exportation of the pilot data into a
central repository. Following the pilot,
the Agency plans to conduct annual
data collections beginning in 2013 with
the initial data collection for select
restaurant facility types, followed by the
initial data collection for select
institutional foodservice facility types in
2014 and select retail food store facility
types in 2015. The results of the initial
data collection for each of the facility
types will serve as the baseline
measurement from which trends will be
analyzed. Two additional data
collection periods for each of the facility
types are planned at 3-year intervals
after the initial data collection for
purposes of analyzing trends.
TABLE 1—SUMMARY OF DATA COLLECTION TIME FRAMES 1
Industry segment
Facility types included in the survey
Restaurants ...........................................
Full Service Restaurants
Fast Food Restaurants ........................
Hospitals
Nursing Homes ....................................
Elementary Schools (K–6) ...................
Deli Departments/Stores
Meat and Poultry Departments/Markets
Seafood Departments/Markets ............
Produce Departments/Markets ............
Institutional Foodservice .......................
Retail Food Stores ................................
Year for initial data
collection (baseline
measurement)
Second data
collection period
Third and final
data collection
period
2013
2016
2019
2014
2017
2020
2015
2018
2021
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1 Data collections for each of the facility types within an industry segment will be conducted using a 3-year interval period. Initial data collection
will serve as the baseline. Subsequent collections will provide the data needed to analyze trends.
A description of the facility types
included in the proposed survey is
included in table 2:
TABLE 2—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
Industry segment
Restaurants ...................
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Facility type
Full Service Restaurants.
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Description
Establishments 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.
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TABLE 2—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY—Continued
Industry segment
Description
Fast Food Restaurants
Institutional Foodservice
Facility type
Also referred to as quick service restaurants and defined as any restaurant that is not a full
service restaurant.
Foodservice operations that serve patients, staff, and hospital visitors in a traditional hospital
setting. Individuals who are acutely ill to those who are immunocompromised are a target
population for data collection.
Foodservice operations that serve highly susceptible populations living in a group care setting. The elderly (55+ years) is the target population for the data collection. Also includes
assisted living facilities.
Foodservice operations that serve students from one or more grade levels from preschool
through Grade 5. Young children are a target population for the data collection.
Departments in retail food stores where potentially hazardous foods (time/temperature control for safety foods) such as luncheon meats and cheeses are sliced for the customer
and where sandwiches and salads are prepared onsite or received from a commissary in
bulk containers, portioned, and displayed. Freestanding cheese shops are categorized as
delis. Parts of the deli may also include:
• Salad bars and other food bars maintained by the deli department manager;
• Areas where meat or poultry are cooked and offered for sale as ready-to-eat;
• Pizza stands; and
• Limited bakery operations attached to or adjacent the deli.
Meat and poultry departments in a retail food store, as well as any freestanding meat market or butcher shop that sells raw meat or poultry directly to the consumer.
Seafood departments in retail food stores and freestanding seafood markets that sell seafood directly to the consumer including the preparation and sale of raw and/or ready-toeat seafood. In-store sushi bars are considered part of the seafood department for the
purposes of the data collection.
Areas or departments where produce is cut, prepared, stored, or displayed. A produce department may include salad bars that are managed by the produce manager, as well as
juicers.
Hospitals .....................
Nursing Homes ...........
Retail Food Stores ........
Elementary Schools
(K–6).
Deli Departments/
Stores.
Meat and Poultry Departments/Markets.
Seafood Departments/
Markets.
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Produce Departments/
Markets.
A geographical information system
database containing a listing of
businesses throughout the United States
will be used as the establishment
inventory for the data collections. FDA’s
Center for Food Safety and Applied
Nutrition (CFSAN) Biostatistical
Branch, in collaboration with the FDA
National Retail Food Team, will perform
a series of filtering processes of the
various database food establishment
categories to ensure establishments are
correctly classified and considered
eligible to participate in the survey
based on the descriptions in table 2.
To further determine the pool of
establishments eligible for selection, an
effort will be made to exclude
operations that handle only
prepackaged food items or conduct lowrisk 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 vast majority of selected
establishments are to be chosen from
risk categories 2 through 4.
FDA has approximately 25 Regional
Retail Food Specialists (Specialists) who
will serve as the data collectors for the
10-year study. The Specialists are
geographically dispersed throughout the
United States and possess technical
expertise in retail food safety and a solid
understanding of the operations within
each of the facility types to be surveyed.
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The Specialists are also standardized by
FDA’s CFSAN personnel in the
application and interpretation of the
FDA Model Food Code (Ref. 5). The
geographical distribution of Specialists
throughout the United States allows for
a broad sampling of facility types in all
regions of the United States; therefore,
establishments will be randomly
selected to participate in the study from
among all eligible establishments
located within a 150-mile radius of each
of the Specialists’ home locations.
The pilot will include approximately
4 data collection inspections for each of
the approximately 25 Specialists, or a
total of 100 inspections. In order to
obtain a sufficient number of
observations to conduct statistically
significant analysis, the FDA CFSAN
Biostatistical Branch has determined,
based on the previous 10-year foodborne
illness risk factor study that was
performed, that approximately 400 data
collection inspections of each facility
type are needed during the initial and
subsequent data collection periods. The
sample for each data collection period
will be evenly distributed among
Specialists. Given that participation in
the study by industry is voluntary and
the status of any given randomly
selected establishment is subject to
change, substitute establishments will
be selected for each Specialist for cases
where the restaurant facility is
misclassified, closed, or otherwise
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unavailable, unable, or unwilling to
participate.
Prior to conducting the data
collection, Specialists will contact the
state or local jurisdiction that has
regulatory responsibility for conducting
retail food inspections for the selected
establishment. The Specialist will verify
with the jurisdiction that the facility has
been properly classified for the
purposes of the study and is still in
operation. The Specialist will also
ascertain whether the selected facility is
under legal notice from the state or local
regulatory authority. If the selected
facility is under legal notice, the
Specialist will not conduct a data
collection, and a substitute
establishment will be used. An
invitation will be extended to the state
or local regulatory authority to
accompany the Specialist on the data
collection visit.
A standard data collection form will
be used by the Specialists during each
inspection. 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.
Section 3 includes three parts (parts A–
C) for tabulating the Specialists’
observations of the food employees’
behaviors and practices in limiting
contamination, proliferation, and
survival of food safety hazards (part A);
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the industry food safety management
being implemented by the facility (part
B); and the frequency of food employee
hand washing (part C).
The information in Section 1—
Establishment Information of the form
will be obtained during an interview
with the establishment owner or person
in charge by the Specialist and will
include a standard set of questions. The
information in Section 2—Regulatory
Authority Information will be obtained
during an interview with the program
director of the state or local jurisdiction
that has regulatory responsibility for
conducting inspections for the selected
establishment. Section 3, part A will be
collected from the Specialists’ direct
observations of food employee
behaviors and practices. Infrequent,
nonstandard questions may be asked by
the Specialists if clarification is needed
on the food safety procedure or practice
being observed. For Section 3, part B of
the form, Specialists will make direct
observations and ask follow up
questions of industry management to
obtain information on the extent to
which the food establishments have
developed and implemented food safety
management systems. Section 3, part C
of the form will involve direct
observations of hand washing frequency
by the Specialists. No questions will be
asked in the completion of this part of
the form.
Due to the infrequent and
nonstandard nature of the questions that
may or may not be asked to clarify
direct observations made by the
Specialists in completing Section 3,
parts A and C of the data collection
form, only the burden associated with
the information collection related to the
completion of Sections 1 and 2 and
Section 3, part B of the form is included
in burden estimates. For each data
collection, the respondents will include
the person in charge of the selected
facility and the program director of the
respective regulatory authority. For the
pilot, 25 Specialists will conduct 4 data
collection inspections; thus, FDA
estimates the number of respondents to
be 200 (25 Specialists × 4 data collection
inspections × 2 respondents per data
collection). The estimate of the hours
per response is based on its previous
experience with collecting similar
information in previous data collection
efforts. We estimate that it will take
each of the respondents 15 minutes
(0.25 hours) to answer the questions
related to Sections 1 and 2 and Section
3, part B of the form, for a total of 50
hours. FDA bases its estimate of the
number of respondents during the
subsequent activities (data collections)
36547
on 400 inspections being conducted in
each facility type. FDA CFSAN’s
Biostatistical Branch has determined
that 400 inspections are necessary to
provide the sufficient number of
observations needed to conduct a
statistically significant analysis of the
data. The data collections in the
Restaurant Segment will occur in 2013,
2016, and 2019, and will each consist of
1,600 respondents. We estimate that it
will take each respondent 15 minutes
(0.25 hours) to answer the questions
related to Sections 1 and 2 and Section
3, part B of the form, for a total of 400
hours. The data collections in the
Institutional Foodservice Segment will
occur in 2014, 2017, and 2020, and will
each consist of 2,400 respondents. We
estimate that it will take each
respondent 15 minutes (0.25 hours) to
answer the questions related to Sections
1 and 2 and Section 3, part B of the
form, for a total of 600 hours. The data
collections in the Retail Food Store
Segment will occur in 2015, 2018, and
2021, and will each consist of 3,200
respondents. We estimate that it will
take a respondent 15 minutes (0.25
hours) to answer the questions related to
Sections 1 and 2 and Section 3, part B
of the form, for a total of 800 hours.
Thus, the total estimated burden is
5,450 hours.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of responses per
respondent
No. of respondents
Activity
Total annual
responses
Average burden per response
Total hours
200
1
200
0.25
(15 minutes)
50
2013 Baseline Data Collection—Restaurant Segment (includes two facility types) ..................................................
1,600
1
1,600
0.25
(15 minutes)
400
2014 Baseline Data Collection—Institutional Foodservice
Segment (includes three facility types) ............................
2,400
1
2,400
0.25
(15 minutes)
600
2015 Baseline Data Collection—Retail Food Store Segment (includes four facility types) ....................................
3,200
1
3,200
0.25
(15 minutes)
800
2016 Second Data Collection—Restaurant Segment (includes two facility types) ..................................................
1,600
1
1,600
0.25
(15 minutes)
400
2017 Second Data Collection—Institutional Foodservice
Segment (includes three facility types) ............................
2,400
1
2,400
0.25
(15 minutes)
600
2018 Second Data Collection—Retail Food Store Segment (includes four facility types) ....................................
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2012 Pilot Data Collection to Practice Use of Form and
Methods and Exportation of Data Into Central Repository ....................................................................................
3,200
1
3,200
0.25
(15 minutes)
800
2019 Third and Final Data Collection—Restaurant Segment (includes two facility types) .....................................
1,600
1
1,600
0.25
(15 minutes)
400
2020 Third and Final Data Collection—Institutional
Foodservice Segment (includes three facility types) .......
2,400
1
2,400
0.25
(15 minutes)
600
2021 Third and Final Data Collection—Retail Food Store
Segment (includes four facility types) ..............................
3,200
1
3,200
0.25
(15 minutes)
800
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TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of respondents
No. of responses per
respondent
Total annual
responses
Average burden per response
........................
........................
........................
........................
Activity
Total ..............................................................................
1 There
5,450
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
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Total hours
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Report of the FDA Retail Food
Program Steering Committee. Database
of Foodborne Illness Risk Factors (2000).
Available at: https://www.fda.gov/
downloads/Food/FoodSafety/Retail
FoodProtection/FoodborneIllnessand
RiskFactorReduction/
RetailFoodRiskFactorStudies/
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://www.fda.gov/Food/FoodSafety/
RetailFoodProtection/FoodborneIllness
andRiskFactorReduction/
RetailFoodRiskFactorStudies/
ucm089696.htm.
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://www.fda.gov/downloads/Food/
FoodSafety/RetailFoodProtection/
FoodborneIllnessand
RiskFactorReduction/
RetailFoodRiskFactorStudies/
UCM224682.pdf.
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://www.fda.gov/
downloads/Food/FoodSafety/RetailFood
Protection/FoodborneIllnessand
RiskFactorReduction/
RetailFoodRiskFactorStudies/
UCM224152.pdf.
5. FDA Model Food Code. Available
at: https://www.fda.gov/Food/
FoodSafety/RetailFoodProtection/
FoodCode/default.htm.
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Dated: June 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14850 Filed 6–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dermatologic
and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 26, 2012, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (Rm. 1503), 10903
New Hampshire Avenue, Silver Spring,
MD 20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, (301) 796–
9001, Fax: (301) 847–8533, email:
DODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On July 26, 2012, during the
morning session, the committee will
discuss a supplement to biologics
license application (BLA) 125156 for
LUCENTIS (ranibizumab) injection by
Genentech, Inc., for the treatment of
diabetic macular edema (DME).
Ranibizumab injection is currently
approved for the treatment of
neovascular (wet) age-related macular
degeneration (AMD) and macular edema
following retinal vein occlusion (RVO).
During the afternoon session, the
committee will discuss new biologics
license application (BLA) 125422,
ocriplasmin intravitreal injection
(proposed tradename, Jetrea) by
ThromboGenics, Inc., indicated for the
treatment of symptomatic vitreomacular
adhesions (sVMA) including macular
hole.
FDA intends to make background
materials available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 13, 2012. Oral
presentations from the public will be
scheduled between approximately 10
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Pages 36544-36548]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14850]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0547]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey on the Occurrence of Foodborne Illness Risk
Factors in Selected Retail and Foodservice Facility Types (2013-2022)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a survey entitled ``Occurrence of Foodborne
Illness Risk Factors in Selected Retail and Foodservice Facility Types
(2013-2022).''
DATES: Submit written or electronic comments on the collection of
information by August 20, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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 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
Retail and Foodservice Facility Types (2013-2022)--(OMB Control Number
0910-NEW)
I. Background
In 1998, the U.S. Food and Drug Administration's National Retail
Food Team initiated a 10-year voluntary survey 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 (CDC) as contributing factors to foodborne
illness outbreaks at the retail level. Specifically, the survey
included data collection inspections of various types
[[Page 36545]]
of retail and foodservice establishments at 5-year intervals (1998,
2003, and 2008) in order 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.
Contaminated Equipment/Protection from Contamination.
FDA developed reports summarizing the findings for each of the
three data collection periods (1998, 2003, and 2008) (Refs. 1-3). 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).
The research obtained from these studies provides FDA a solid
foundation for developing a national retail food program model that can
be used by Federal, state, local, and tribal agencies to:
Identify essential food safety program performance
measurements;
Assess strengths and gaps in the design, structure, and
delivery of program services;
Establish program priorities and intervention strategies
focused on reducing the occurrence of foodborne illness risk factors;
and
Create a mechanism that justifies program resources and
allocates them to program areas that will provide the most significant
public health benefits.
Using this 10-year survey as a foundation, FDA is proposing to
conduct a new voluntary survey encompassing annual data collections
over a 10-year period. The survey will determine the following for each
facility type included in the study:
The foodborne illness risk factors that are in most need
of priority attention during each data collection period;
Trends of improvement or regression in foodborne illness
risk factor occurrence over time; and
The impact of industry food safety management systems in
controlling the occurrence of foodborne illness risk factors.
The results of the proposed study will be used to:
Formulate Agency retail food safety policies and
initiatives;
Identify retail food work plan priorities and allocate
resources to enhance retail food safety nationwide;
Generate nationally representative estimates of the
prevalence of foodborne illness risk factors and trends of improvement
and regression over time; and
Recommend best practices and targeted intervention
strategies to assist the retail and foodservice industry and state,
local, and tribal regulators with reducing foodborne illness risk
factors.
The statutory basis for FDA conducting this survey is the Public
Health Service Act (the PHS Act) (42 U.S.C. 243, section 311(a)) (Also
21 CFR 5.10(a)(2) and (4)), which requires that FDA provide assistance
to state and local governments relative to the prevention and
suppression of communicable diseases. In addition, the PHS Act requires
that FDA cooperate with and aid state and local authorities in the
enforcement of their health regulations and provide advice on matters
relating to the preservation and improvement of public health.
Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301)
and Economy Act (31 U.S.C. 1535) require that FDA provide assistance to
other Federal, state, and local governmental bodies.
In 2012, FDA will conduct a pilot data collection to practice the
use of the data collection form and methods and test exportation of the
pilot data into a central repository. Following the pilot, the Agency
plans to conduct annual data collections beginning in 2013 with the
initial data collection for select restaurant facility types, followed
by the initial data collection for select institutional foodservice
facility types in 2014 and select retail food store facility types in
2015. The results of the initial data collection for each of the
facility types will serve as the baseline measurement from which trends
will be analyzed. Two additional data collection periods for each of
the facility types are planned at 3-year intervals after the initial
data collection for purposes of analyzing trends.
Table 1--Summary of Data Collection Time Frames \1\
----------------------------------------------------------------------------------------------------------------
Year for initial
Facility types data collection Second data Third and final
Industry segment included in the (baseline collection period data collection
survey measurement) period
----------------------------------------------------------------------------------------------------------------
Restaurants...................... Full Service 2013 2016 2019
Restaurants
Fast Food
Restaurants.
Institutional Foodservice........ Hospitals 2014 2017 2020
Nursing Homes......
Elementary Schools
(K-6).
Retail Food Stores............... Deli Departments/ 2015 2018 2021
Stores
Meat and Poultry
Departments/
Markets.
Seafood Departments/
Markets.
Produce Departments/
Markets.
----------------------------------------------------------------------------------------------------------------
\1\ Data collections for each of the facility types within an industry segment will be conducted using a 3-year
interval period. Initial data collection will serve as the baseline. Subsequent collections will provide the
data needed to analyze trends.
A description of the facility types included in the proposed survey
is included in table 2:
Table 2--Description of the Facility Types Included in the Survey
----------------------------------------------------------------------------------------------------------------
Industry segment Facility type Description
----------------------------------------------------------------------------------------------------------------
Restaurants.......................... Full Service Establishments where customers place their order
Restaurants. 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.
[[Page 36546]]
Fast Food Restaurants.. Also referred to as quick service restaurants
and defined as any restaurant that is not a
full service restaurant.
Institutional Foodservice............ Hospitals.............. Foodservice operations that serve patients,
staff, and hospital visitors in a traditional
hospital setting. Individuals who are acutely
ill to those who are immunocompromised are a
target population for data collection.
Nursing Homes.......... Foodservice operations that serve highly
susceptible populations living in a group care
setting. The elderly (55+ years) is the target
population for the data collection. Also
includes assisted living facilities.
Elementary Schools (K- Foodservice operations that serve students from
6). one or more grade levels from preschool through
Grade 5. Young children are a target population
for the data collection.
Retail Food Stores................... Deli Departments/Stores Departments in retail food stores where
potentially hazardous foods (time/temperature
control for safety foods) such as luncheon
meats and cheeses are sliced for the customer
and where sandwiches and salads are prepared
onsite or received from a commissary in bulk
containers, portioned, and displayed.
Freestanding cheese shops are categorized as
delis. Parts of the deli may also include:
Salad bars and other food bars
maintained by the deli department manager;
Areas where meat or poultry are
cooked and offered for sale as ready-to-eat;
Pizza stands; and
Limited bakery operations attached to
or adjacent the deli.
Meat and Poultry Meat and poultry departments in a retail food
Departments/Markets. store, as well as any freestanding meat market
or butcher shop that sells raw meat or poultry
directly to the consumer.
Seafood Departments/ Seafood departments in retail food stores and
Markets. freestanding seafood markets that sell seafood
directly to the consumer including the
preparation and sale of raw and/or ready-to-eat
seafood. In-store sushi bars are considered
part of the seafood department for the purposes
of the data collection.
Produce Departments/ Areas or departments where produce is cut,
Markets. prepared, stored, or displayed. A produce
department may include salad bars that are
managed by the produce manager, as well as
juicers.
----------------------------------------------------------------------------------------------------------------
A geographical information system database containing a listing of
businesses throughout the United States will be used as the
establishment inventory for the data collections. FDA's Center for Food
Safety and Applied Nutrition (CFSAN) Biostatistical Branch, in
collaboration with the FDA National Retail Food Team, will perform a
series of filtering processes of the various database food
establishment categories to ensure establishments are correctly
classified and considered eligible to participate in the survey based
on the descriptions in table 2.
To further determine the pool of establishments eligible for
selection, an effort will be made to exclude 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 vast majority of selected
establishments are to be chosen from risk categories 2 through 4.
FDA has approximately 25 Regional Retail Food Specialists
(Specialists) who will serve as the data collectors for the 10-year
study. The Specialists are geographically dispersed throughout the
United States and possess technical expertise in retail food safety and
a solid understanding of the operations within each of the facility
types to be surveyed. The Specialists are also standardized by FDA's
CFSAN personnel in the application and interpretation of the FDA Model
Food Code (Ref. 5). The geographical distribution of Specialists
throughout the United States allows for a broad sampling of facility
types in all regions of the United States; therefore, establishments
will be randomly selected to participate in the study from among all
eligible establishments located within a 150-mile radius of each of the
Specialists' home locations.
The pilot will include approximately 4 data collection inspections
for each of the approximately 25 Specialists, or a total of 100
inspections. In order to obtain a sufficient number of observations to
conduct statistically significant analysis, the FDA CFSAN
Biostatistical Branch has determined, based on the previous 10-year
foodborne illness risk factor study that was performed, that
approximately 400 data collection inspections of each facility type are
needed during the initial and subsequent data collection periods. The
sample for each data collection period will be evenly distributed among
Specialists. Given that participation in the study by industry is
voluntary and the status of any given randomly selected establishment
is subject to change, substitute establishments will be selected for
each Specialist for cases where the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
Prior to conducting the data collection, Specialists will contact
the state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist will verify with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist will also ascertain whether the selected
facility is under legal notice from the state or local regulatory
authority. If the selected facility is under legal notice, the
Specialist will not conduct a data collection, and a substitute
establishment will be used. An invitation will be extended to the state
or local regulatory authority to accompany the Specialist on the data
collection visit.
A standard data collection form will be used by the Specialists
during each inspection. 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. Section 3 includes three parts
(parts A-C) for tabulating the Specialists' observations of the food
employees' behaviors and practices in limiting contamination,
proliferation, and survival of food safety hazards (part A);
[[Page 36547]]
the industry food safety management being implemented by the facility
(part B); and the frequency of food employee hand washing (part C).
The information in Section 1--Establishment Information of the form
will be obtained during an interview with the establishment owner or
person in charge by the Specialist and will include a standard set of
questions. The information in Section 2--Regulatory Authority
Information will be obtained during an interview with the program
director of the state or local jurisdiction that has regulatory
responsibility for conducting inspections for the selected
establishment. Section 3, part A will be collected from the
Specialists' direct observations of food employee behaviors and
practices. Infrequent, nonstandard questions may be asked by the
Specialists if clarification is needed on the food safety procedure or
practice being observed. For Section 3, part B of the form, Specialists
will make direct observations and ask follow up questions of industry
management to obtain information on the extent to which the food
establishments have developed and implemented food safety management
systems. Section 3, part C of the form will involve direct observations
of hand washing frequency by the Specialists. No questions will be
asked in the completion of this part of the form.
Due to the infrequent and nonstandard nature of the questions that
may or may not be asked to clarify direct observations made by the
Specialists in completing Section 3, parts A and C of the data
collection form, only the burden associated with the information
collection related to the completion of Sections 1 and 2 and Section 3,
part B of the form is included in burden estimates. For each data
collection, the respondents will include the person in charge of the
selected facility and the program director of the respective regulatory
authority. For the pilot, 25 Specialists will conduct 4 data collection
inspections; thus, FDA estimates the number of respondents to be 200
(25 Specialists x 4 data collection inspections x 2 respondents per
data collection). The estimate of the hours per response is based on
its previous experience with collecting similar information in previous
data collection efforts. We estimate that it will take each of the
respondents 15 minutes (0.25 hours) to answer the questions related to
Sections 1 and 2 and Section 3, part B of the form, for a total of 50
hours. FDA bases its estimate of the number of respondents during the
subsequent activities (data collections) on 400 inspections being
conducted in each facility type. FDA CFSAN's Biostatistical Branch has
determined that 400 inspections are necessary to provide the sufficient
number of observations needed to conduct a statistically significant
analysis of the data. The data collections in the Restaurant Segment
will occur in 2013, 2016, and 2019, and will each consist of 1,600
respondents. We estimate that it will take each respondent 15 minutes
(0.25 hours) to answer the questions related to Sections 1 and 2 and
Section 3, part B of the form, for a total of 400 hours. The data
collections in the Institutional Foodservice Segment will occur in
2014, 2017, and 2020, and will each consist of 2,400 respondents. We
estimate that it will take each respondent 15 minutes (0.25 hours) to
answer the questions related to Sections 1 and 2 and Section 3, part B
of the form, for a total of 600 hours. The data collections in the
Retail Food Store Segment will occur in 2015, 2018, and 2021, and will
each consist of 3,200 respondents. We estimate that it will take a
respondent 15 minutes (0.25 hours) to answer the questions related to
Sections 1 and 2 and Section 3, part B of the form, for a total of 800
hours. Thus, the total estimated burden is 5,450 hours.
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
2012 Pilot Data Collection to 200 1 200 0.25 50
Practice Use of Form and (15 minutes)
Methods and Exportation of Data
Into Central Repository........
2013 Baseline Data Collection-- 1,600 1 1,600 0.25 400
Restaurant Segment (includes (15 minutes)
two facility types)............
2014 Baseline Data Collection-- 2,400 1 2,400 0.25 600
Institutional Foodservice (15 minutes)
Segment (includes three
facility types)................
2015 Baseline Data Collection-- 3,200 1 3,200 0.25 800
Retail Food Store Segment (15 minutes)
(includes four facility types).
2016 Second Data Collection-- 1,600 1 1,600 0.25 400
Restaurant Segment (includes (15 minutes)
two facility types)............
2017 Second Data Collection-- 2,400 1 2,400 0.25 600
Institutional Foodservice (15 minutes)
Segment (includes three
facility types)................
2018 Second Data Collection-- 3,200 1 3,200 0.25 800
Retail Food Store Segment (15 minutes)
(includes four facility types).
2019 Third and Final Data 1,600 1 1,600 0.25 400
Collection--Restaurant Segment (15 minutes)
(includes two facility types)..
2020 Third and Final Data 2,400 1 2,400 0.25 600
Collection--Institutional (15 minutes)
Foodservice Segment (includes
three facility types)..........
2021 Third and Final Data 3,200 1 3,200 0.25 800
Collection--Retail Food Store (15 minutes)
Segment (includes four facility
types).........................
[[Page 36548]]
Total....................... .............. .............. .............. .............. 5,450
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Report of the FDA Retail Food Program Steering Committee.
Database of Foodborne Illness Risk Factors (2000). Available at: https://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/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://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm089696.htm.
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://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224682.pdf.
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://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf.
5. FDA Model Food Code. Available at: https://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/default.htm.
Dated: June 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14850 Filed 6-18-12; 8:45 am]
BILLING CODE 4160-01-P
