73596 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

section E that currently asks ‘‘May we 

give your name and contact information 

to the company that makes the product 

(manufacturer) to help them evaluate 

the product?’’ to ‘‘If you do NOT want 

your identity disclosed to the 

manufacturer, place an ’X’ in this box.’’ 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

FDA Center/21 CFR section/FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total 

Center for Biologics Evaluation and Research/

Center for Drug Evaluationand Research:.

Form 3500 ..................................................... 14,727 1 14,727 0.66 (40 minutes) ......... 9,720 

Form 3500A (§§ 310.305, 314.80, 314.98, 

600.80, 1271.350).

599 98 58,702 1.21 ............................... 71,029 

Center for Devices and Radiological Health:.

Form 3500 ..................................................... 5,233 1 5,233 0.66 (40 minutes) ......... 3,454 

Form 3500A (§ 803) ....................................... 2,277 296 673,992 1.21 ............................... 815,530 

Center for Food Safety and Applied Nutrition:.

Form 3500 ..................................................... 1,793 1 1,793 0.66 (40 minutes) ......... 1,183 

Form 3500A ................................................... 1,659 1 1,659 1.21 ............................... 2,007 

Center for Tobacco Products.

Form 3500 ..................................................... 39 1 39 0.66 (40 minutes) ......... 26 

All Centers.

Form 3500B ................................................... 13,750 1 13,750 0.46 (30 minutes) ......... 6,325 

Total ............................................................... ........................ ........................ ........................ ....................................... 909,274 

VI. References 

1. Kessler, D. A, ‘‘Introducing MEDWatch: 

A New Approach to Reporting Medication 

and Device Adverse Effects and Product 

Problems,’’ Journal of the American Medical 

Association, 269(21), June 2, 1993, pp. 2765– 

2768. 

Dated: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29064 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Restaurant 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, including each proposed 

extension of an existing 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 Restaurant Facility Types 

(2013–2022).’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 9, 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, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73597 

Survey on the Occurrence of Foodborne 

Illness Risk Factors in Selected 

Restaurant Facility Types (2013–2022) 

(OMB Control Number 0910–0744) 

I. Background 

In 2013–2014, the U.S. Food and Drug 

Administration (FDA) initiated a study 

in two foodservice facility types: Full 

service and fast food restaurants. The 

study will span 10 years in its entirety 

and aims to: 

• Assist FDA with developing retail 

food safety initiatives and policies 

focused on the control 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. (i.e. food 

from unsafe sources, poor personal 

hygiene, inadequate cooking, improper 

holding/time and temperature, and 

contaminated equipment/crosscontamination); 

• 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. 

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 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 data from the 2013–2014 

information collection in restaurants is 

currently being analyzed by FDA. A 

report summarizing the findings is 

expected to be released in 2015. In order 

to analyze trends, FDA is proposing to 

conduct two additional data collections 

in 2017–2018 and 2021–2022 using the 

same methodology employed in the 

2013–2014 data collection. This 

methodology 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 restaurant facility type during each 

data collection period. 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. 1). 

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 

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. 1). 

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 

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73598 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

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 survey is not duplicative. 

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. FDA will be pilot testing the 

use of hand-held technology during its 

2015–2016 risk factor study data 

collection in institutional foodservice 

and retail food stores, with the goal to 

have it fully implemented for the 2017– 

2018 data collection in restaurants. 

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 the 2017–2018 data 

collection is as follows. For each data 

collection, the respondents will include: 

(1) The person in charge of the selected 

restaurant facility (whether it be a fast 

food or full service restaurant); 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 the same number of 

data collections will be required in each 

of the two restaurant facility types as 

was required in the 2013–2014 data 

collection (i.e. 400). Therefore, the total 

number of responses for restaurants 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 as he or 

she completes Sections 1 and 3 of the 

form. 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 the same 

facility types during the 2013–2014 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), respectfully, to accompany 

the data collectors while they complete 

Sections 1 and 3 of the form. In 

comparison, for the 2013–2014 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 both 

the program director’s and the person in 

charge’s responses, is 134 minutes (104 

+ 30)(2.23 hours). The total burden 

estimate for a data collection in a fast 

food restaurant, including the both the 

program director’s and the person in 

charge’s responses, is 112 minutes 82 + 

30) (1.86 hours). 

Based on the number of entry refusals 

from the 2013–2014 data collection, we 

estimate a refusal rate of 2 percent. The 

estimate of the time per non-respondent 

is five minutes (0.08 hours) for the 

person in charge to listen to the purpose 

of the visit and provide a verbal refusal 

of entry. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73599 

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 

2017–2018 Data Collection (Fast Food Restaurants)—Completion of Sections 1 and 

3.

400 1 400 1.36 ........... 544 

2017–2018 Data Collection (Full Service 

Restaurants)—Completion of Sections 1 

and 3.

400 1 400 1.73 ........... 692 

2017–2018 Data Collection-Completion of 

Section 2—All Facility 

Types.

800 1 800 0.5 (30 minutes).400 

2017–2018 Data Collection-Entry Refusals— 

All Facility Types.

16 1 16 0.08 (5 minutes).1.28 

Total hours ............ ............... 1,637.28 

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

II. Reference 

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://

www.regulations.gov. 

1. FDA Food Code. Available at: 

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

GuidanceRegulation/

RetailFoodProtection/FoodCode/

default.htm. 

Dated: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29065 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0320] 

Determination That PFIZERPEN 

(Penicillin G Potassium) Injection, 1 

Million Units/Vial, Was Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for penicillin G 

potassium injection, 1 million units/

vial, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6250, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

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

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products with 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (21 CFR 314.161). FDA may 

not approve an ANDA that does not 

refer to a listed drug. 

PFIZERPEN (penicillin G potassium) 

Injection, 1 million units/vial, is the 

subject of ANDA 60–657, held by Pfizer, 

Inc., and initially approved on August 

30, 1968. ANDA 60–657 is considered 

the designated reference standard. 

PFIZERPEN is indicated in the 

treatment of serious infections caused 

by susceptible strains of the designated 

microorganisms in certain conditions 

such as septicemia, pneumonia, 

meningitis, anthrax, and listeria. 

PFIZERPEN (penicillin G potassium) 

Injection, 1 million units/vial, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. Lachman Consultant Services, 

Inc., submitted a citizen petition dated 

May 27, 2008 (Docket No. FDA–2008– 

P–0320), under 21 CFR 10.30, 

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