75158 Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Notices 

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. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–29488 Filed 12–16–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC); Meeting 

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 following meeting of the 

aforementioned committee: 

Time and Date: 11:00 a.m.–1:00 p.m. 

(EST), January 13, 2015. 

Place: This meeting will be held by 

teleconference. 

Status: Open to the public, limited only by 

the availability of telephone ports. The 

public is welcome to participate during the 

public comment period, tentatively 

scheduled from 12:45 p.m. until 12:50 p.m. 

To participate in the teleconference, please 

dial (877) 930–8819 and enter code 1579739. 

Purpose: The Advisory Committee to the 

Director, CDC, shall advise the Secretary, 

HHS, and the Director, CDC, on policy and 

broad strategies that will enable CDC to fulfill 

its mission of protecting health through 

health promotion, prevention, and 

preparedness. The committee recommends 

ways to prioritize CDC’s activities, improve 

results, and address health disparities. It also 

provides guidance to help CDC work more 

effectively with its various private and public 

sector constituents to make health protection 

a practical reality. 

Matters for Discussion: The Advisory 

Committee to the Director will receive 

updates from the State, Tribal, Local and 

Territorial Subcommittee; the External 

Laboratory Safety Workgroup, and the Public 

Health—Health Care Collaboration 

Workgroup; and an update from the CDC 

Director on the Ebola response. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Carmen Villar, MSW, Designated Federal 

Officer, ACD, CDC, 1600 Clifton Road NE., 

M/S D–14, Atlanta, Georgia 30333; 

Telephone (404) 639–7158; Email: 

GHickman@cdc.gov. 

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. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention (CDC). 

[FR Doc. 2014–29487 Filed 12–16–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2033] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Institutional 

Foodservice and Retail Food Stores 

Facility Types 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 ‘‘Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Institutional 

Foodservice and Retail Food Stores 

Facility Types (2015–2025).’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 17, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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 (2015– 

2025) (OMB Control Number 0910– 

NEW) 

I. Background 

From 1998–2008, 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) 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, 

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Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Notices 75159 

• 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. 1–3). Data from all three 

data collection periods were analyzed to 

detect trends in improvement or 

regression over time and to determine 

whether progress had been made toward 

the goal of reducing the occurrence of 

foodborne illness risk factors in selected 

retail and foodservice facility types (Ref. 

4). 

Using this 10-year survey as a 

foundation, in 2013–2014, FDA initiated 

a new study in full service and fast food 

restaurants. This study will span 10 

years with additional data collections 

planned for 2017–2018 and 2021–2022. 

FDA is proposing to collect data in 

select institutional foodservice and 

retail food store facility types in 2015– 

2016. This proposed study will also 

span 10 years with additional data 

collections planned for 2019–2020 and 

2023–2024. 

TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY

Facility type Description 

Healthcare Facilities ............. Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible populations as defined as follows: 

• Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing meals 

and transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals in the cafeteria may also be served to hospital staff and visitors). 

• Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care living setting such as nursing homes and assisted living facilities. 

NOTE: For the purposes of this study, healthcare facilities that do not prepare or serve food to a highly susceptible population, such as mental healthcare facilities, are not included in this facility type category. 

Schools (K–12) ..................... Foodservice operations that have the primary function of preparing and serving meals for students in one or more 

grade levels from Kindergarten through Grade 12. A school foodservice may be part of a public or private institution. 

Retail Food Stores ............... Supermarkets and grocery stores that have a deli department/operation as described as follows:

• Deli department/operation—Areas in a retail food store where foods, such as luncheon meats and 

cheeses, are sliced for the customers and where sandwiches and salads are prepared on-site or received 

from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include: 

• Salad bars, pizza stations, and other food bars managed by the deli department manager. 

• Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are managed by 

the deli department manager. 

Data will also be collected in the following areas of a supermarket or grocery store, if present: 

• Meat and seafood department/operation—Areas in a retail food store where raw animal food products, 

such as beef, pork, poultry, or seafood, are cut, prepared, stored, or displayed for sale to the consumer. 

• Produce department/operation—Areas in a retail food store where produce is cut, prepared, stored, or displayed for sale to the consumer. A produce operation may include salad bars or juice stations that are 

managed by the produce manager. 

The purpose of the study is to: 

• Assist FDA with developing retail 

food safety initiatives and policies 

focused on the control of foodborne 

illness risk factors; 

• Identify retail food safety work plan 

priorities and allocate resources to 

enhance retail food safety nationwide; 

• Track changes in the occurrence of 

foodborne illness risk factors in retail 

and foodservice establishments over 

time; and 

• Inform recommendations to the 

retail and foodservice industry and 

state, local, tribal, and territorial 

regulatory professionals on reducing the 

occurrence of foodborne illness risk 

factors. 

The statutory basis for FDA 

conducting this study is derived from 

the Public Health Service Act (42 U.S.C. 

243, Section 311(a)). Responsibility for 

carrying out the provisions of the Act 

relative to food protection was 

transferred to the Commissioner of Food 

and Drugs in 1968 (21 CFR 5.10(a)(2) 

and (4)). Additionally, the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301 

et seq) and the Economy Act (31 U.S.C. 

1535) require FDA to provide assistance 

to other Federal, state, and local 

government bodies. 

The objectives of the study are to: 

• Identify the foodborne illness risk 

factors that are in most need of priority 

attention during each data collection 

period; 

• Track trends in the occurrence of 

foodborne illness risk factors over time; 

• Examine potential correlations 

between operational characteristics of 

food establishments and the control of 

foodborne illness risk factors; 

• Examine potential correlations 

between elements within regulatory 

retail food protection programs and the 

control of foodborne illness risk factors; 

and 

• Evaluate the impact of industry 

food safety management systems in 

controlling the occurrence of foodborne 

illness risk factors. 

The methodology to be used for this 

information collection is described as 

follows. In order to obtain a sufficient 

number of observations to conduct 

statistically significant analysis, FDA 

will conduct approximately 400 data 

collections in each 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 

will be used as the establishment 

inventory for the data collections. FDA 

will sample establishments from the 

inventory based on the descriptions in 

table 1. FDA does not intend to sample 

operations that handle only 

prepackaged food items or conduct low 

risk food preparation activities. The 

FDA Food Code contains a grouping of 

establishments by risk, based on the 

type of food preparation that is normally 

conducted within the operation (Ref. 5). 

The intent is to sample establishments 

that fall under risk categories 2 through 

4. 

FDA has approximately 25 Regional 

Retail Food Specialists (Specialists) who 

will serve as the data collectors for the 

10-year study. The Specialists are 

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75160 Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Notices 

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 will be established 

which are equal to the 150 mile radius 

around a Specialist’s home location. 

The sample will be selected randomly 

from among all eligible establishments 

located within these sampling zones. 

The Specialists are generally located in 

major metropolitan areas (i.e. 

population centers) across the 

contiguous United States. Population 

centers usually contain a large 

concentration of the establishments 

FDA intends to sample. Sampling from 

the 150 mile radius sampling zones 

around the Specialists’ home locations 

provides three advantages to the study: 

1. It provides a cross section of urban 

and rural areas from which to sample 

the eligible establishments. 

2. It represents a mix of small, 

medium, and large regulatory entities 

having jurisdiction over the eligible 

establishments. 

3. It reduces overnight travel and 

therefore reduces travel costs incurred 

by the Agency to collect data. 

The sample for each data collection 

period will be evenly distributed among 

Specialists. Given that participation in 

the study by industry is voluntary and 

the status of any given randomly 

selected establishment is subject to 

change, substitute establishments will 

be selected for each Specialist for cases 

where the restaurant facility is 

misclassified, closed, or otherwise 

unavailable, unable, or unwilling to 

participate. 

Prior to conducting the data 

collection, Specialists will contact the 

state or local jurisdiction that has 

regulatory responsibility for conducting 

retail food inspections for the selected 

establishment. The Specialist will verify 

with the jurisdiction that the facility has 

been properly classified for the 

purposes of the study and is still in 

operation. The Specialist will also 

ascertain whether the selected facility is 

under legal notice from the state or local 

regulatory authority. If the selected 

facility is under legal notice, the 

Specialist will not conduct a data 

collection, and a substitute 

establishment will be used. An 

invitation will be extended to the state 

or local regulatory authority to 

accompany the Specialist on the data 

collection visit. 

A standard form will be used by the 

Specialists during each data collection. 

The form is divided into three sections: 

Section 1—‘‘Establishment 

Information;’’ Section 2—‘‘Regulatory 

Authority Information;’’ and Section 3— 

‘‘Foodborne Illness Risk Factor and 

Food Safety Management System 

Assessment.’’ The information in 

Section 1—‘‘Establishment Information’’ 

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 includes three 

parts: Part A for tabulating the 

Specialists’ observations of the food 

employees’ behaviors and practices in 

limiting contamination, proliferation, 

and survival of food safety hazards; Part 

B for assessing the food safety 

management being implemented by the 

facility; and Part C for assessing the 

frequency and extent of food employee 

hand washing. The information in Part 

A will be collected from the Specialists’ 

direct observations of food employee 

behaviors and practices. Infrequent, 

nonstandard questions may be asked by 

the Specialists if clarification is needed 

on the food safety procedure or practice 

being observed. The information in Part 

B will be collected by making direct 

observations and asking follow up 

questions of facility management to 

obtain information on the extent to 

which the food establishment has 

developed and implemented food safety 

management systems. The information 

in Part C will be collected by making 

direct observations of food employee 

hand washing. No questions will be 

asked in the completion of Section 3, 

Part C of the form. 

FDA will collect the following 

information associated with the 

establishment’s identity: Establishment 

name, street address, city, state, zip 

code, county, industry segment, and 

facility type. The establishment 

identifying information is collected to 

ensure the data collections are not 

duplicative. Other information related 

to the nature of the operation, such as 

seating capacity and number of 

employees per shift, will also be 

collected. Data will be consolidated and 

reported in a manner that does not 

reveal the identity of any establishment 

included in the study. 

FDA is working with the National 

Center for Food Protection and Defense 

to develop a Web-based platform in 

FoodSHIELD to collect, store, and 

analyze data for the Retail Risk Factor 

Study. Once developed, this platform 

will be accessible to state, local, 

territorial, and tribal regulatory 

jurisdictions to collect data relevant to 

their own risk factor studies. FDA is 

currently transitioning from the manual 

entry of data to the use of hand-held 

technology. Contingent upon the 

completion of the Web-based platform, 

FDA intends to pilot test the use of 

hand-held technology during its 2015– 

2016 risk factor study data collection in 

institutional foodservice and retail food 

store facility types, with the goal to have 

it fully implemented by the next the 

data collection in restaurant facility 

types that will occur in 2017–2018. 

When a data collector is assigned a 

specific establishment, he or she will 

conduct the data collection and enter 

the information into the Web-based data 

platform. The interface will support the 

manual entering of data, as well as the 

ability to upload a fillable PDF. 

The burden for this collection of 

information is as follows. For each data 

collection, the respondents will include: 

(1) The person in charge of the selected 

facility type (whether it be a healthcare 

facility, school, or supermarket/grocery 

store); and (2) the program director (or 

designated individual) of the respective 

regulatory authority. In order to provide 

the sufficient number of observations 

needed to conduct a statistically 

significant analysis of the data, FDA has 

determined that 400 data collections 

will be required in each of the three 

facility types. Therefore, the total 

number of responses will be 2,400 (400 

data collections × 3 facility types × 2 

respondents per data collection). 

The burden associated with the 

completion of Sections 1 and 3 of the 

form is specific to the persons in charge 

of the selected facilities. It includes the 

time it will take the persons in charge 

to accompany the data collectors during 

the site visit and answer the data 

collectors’ questions. The burden 

related to the completion of Section 2 of 

the form is specific to the program 

directors (or designated individuals) of 

the respective regulatory authorities. It 

includes the time it will take to answer 

the data collectors’ questions and is the 

same regardless of the facility type. 

To calculate the estimate of the hours 

per response, FDA will use the average 

data collection duration for similar 

facility types during FDA’s 2008 Risk 

Factor Study (Ref. 3) plus an extra 30 

minutes (0.5 hours) for the information 

collection related to Section 3, Part B of 

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Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Notices 75161 

the form. FDA estimates that it will take 

the persons in charge of healthcare 

facility types, schools, and retail food 

stores 150 minutes (2.5 hours), 120 

minutes (2 hours), and 180 minutes (3 

hours), respectively, to accompany the 

data collectors while they complete 

Sections 1 and 3 of the form. FDA 

estimates that it will take the program 

director (or designated individual) of 

the respective regulatory authority 30 

minutes (0.5 hours) to answer the 

questions related to Section 2 of the 

form. The total burden estimate for a 

data collection, including both the 

program director’s and the person in 

charge’s responses, in healthcare facility 

types is 180 minutes (150+30)(3 hours), 

in schools is 150 minutes (120+30)(2.5 

hours), and in retail food stores is 210 

minutes (180+30)(3.5 hours). 

Based on the number of entry refusals 

from the 2013–2014 Risk Factor Study 

in the restaurant facility types, we 

estimate a refusal rate of 2 percent in the 

institutional foodservice and retail food 

store facility types. The estimate of the 

time per non-respondent is 5 minutes 

(0.08 hours) for the person in charge to 

listen to the purpose of the visit and 

provide a verbal refusal of entry. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Number of 

nonrespondents 

Number of 

responses 

per nonrespondent 

Total 

annual nonresponses 

Average 

burden per 

response 

Total hours 

2015–2016 Data Collection (Healthcare 

Facilities)—Completion of Sections 1 

and 3 ........................ 400 1 400 .................... .................... .................... 2 .5 1,000 

2015–2016 Data Collection (Schools)— 

Completion of Sections 1 and 3 ............ 400 1 400 .................... .................... .................... 2 800 

2015–2016 Data Collection (Retail Food 

Stores)—Completion 

of Sections 1 and 3 .. 400 1 400 .................... .................... .................... 3 1,200 

2015–2016 Data Collection-Completion of 

Section 2—All Facility 

Types ........................ 1,200 1 1,200 .................... .................... .................... 0 .5 600 

2017–2018 Data Collection-Entry Refusals—All Facility 

Types ........................ .................... .................... .................... 24 1 24 2 0 .08 1 .92 

Total Hours ........... .................... .................... .................... .................... .................... .................... ...................... 3,601 .92 

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

2 (5 minutes.) 

II. References 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://regulations.gov. 

1. ‘‘Report of the FDA Retail Food Program 

Database of Foodborne Illness Risk 

Factors (2000).’’ Available at: 

http://www.fda.gov/downloads/Food/

FoodSafety/RetailFoodProtection/Food

borneIllnessandRiskFactorReduction/

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: 

http://www.fda.gov/downloads/Food/

GuidanceRegulation/RetailFood

Protection/FoodborneIllnessRisk

FactorReduction/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: 

http://www.fda.gov/downloads/Food/

FoodSafety/RetailFoodProtection/

FoodborneIllnessandRiskFactor

Reduction/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: http://www.fda.gov/

downloads/Food/FoodSafety/RetailFood

Protection/FoodborneIllnessandRisk

FactorReduction/RetailFoodRiskFactor

Studies/UCM224152.pdf. 

5. FDA Food Code. Available at: 

http://www.fda.gov/FoodCode. 

Dated: December 8, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29478 Filed 12–16–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

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