Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 1505 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–00230 Filed 1–9–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–0792] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC), as part of its 

continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. To request more 

information on the below proposed 

project or to obtain a copy of the 

information collection plan and 

instruments, call 404–639–7570 or send 

comments to LeRoy Richardson, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the request for Office of 

Management and Budget (OMB) 

approval. Comments are invited on: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Environmental Health Specialists 

Network (EHS-NET) Program (OMB No. 

0920–0792, expires 2/28/2015)— 

Revision—National Center for 

Environmental Health (NCEH), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

The CDC is requesting OMB approval 

for three additional years to use this 

generic clearance for a research program 

focused on identifying the 

environmental causes of foodborne 

illness. 

To date, EHS-Net has conducted four 

studies under this generic clearance. 

The first study collected data on 

improper cooling of hot foods, a food 

handling practice associated with 

foodborne illness and outbreaks. The 

second study collected data on the 

relationship between kitchen manager 

food safety certification and foodborne 

illness risk factors in restaurants. Public 

health agencies are increasingly 

encouraging or requiring certification as 

a foodborne illness prevention measure, 

yet little is known about its 

effectiveness. The third study collected 

data on the environmental factors 

associated with contamination of the 

retail deli environment with Listeria, a 

foodborne illness pathogen ranked 3rd 

in terms of the number of deaths it 

causes. The fourth study collected data 

on restaurant managers’ and workers’ 

food allergen knowledge, attitudes, and 

practices. Food allergens are an 

important food safety issue for 

restaurants. 

The data from the first two studies 

have been disseminated to 

environmental public health/food safety 

regulatory programs and the food 

industry in the form of presentations at 

conferences and meetings, scientific 

journal publications, and Web site 

postings. We will continue to analyze 

and present the data from all four 

studies, and expect that they will 

continue to provide valuable and useful 

data about environmental factors 

associated with foodborne illness 

outbreaks and food safety issues. 

This revision will provide OMB 

clearance for EHS-Net data collections 

conducted in 2015 through 2018 

(approximately one per year). The 

program is revising the generic 

information collection request (ICR) in 

the following ways: 

(1) Because of the re-announcement 

and re-competition of the EHS-Net 

cooperative agreement in 2015, it is 

likely that the sites in which data will 

be collected will differ from the sites in 

which data were collected previously. 

(2) We revised the estimated study 

sample size and burden downward. 

Thus, the estimated burden has been 

reduced. 

(3) We have eliminated proposed 

sample weighting analyses. 

Reducing foodborne illness first 

requires identification and 

understanding of the environmental 

factors that cause these illnesses. We 

need to know how and why food 

becomes contaminated with foodborne 

illness pathogens. This information can 

then be used to determine effective food 

safety prevention methods. Ultimately, 

these actions can lead to increased 

regulatory program effectiveness and 

decreased foodborne illness. The 

purpose of this food safety research 

program is to identify and understand 

environmental factors associated with 

foodborne illness and outbreaks. This 

program is conducted by the 

Environmental Health Specialists 

Network (EHS-Net), a collaborative 

project of CDC, FDA, USDA, and local 

and state sites. 

Environmental factors associated with 

foodborne illness include both food 

safety practices (e.g., inadequate 

cleaning practices) and the factors in the 

environment associated with those 

practices (e.g., worker and retail food 

establishment characteristics). To 

understand these factors, we need to 

continue to collect data from those who 

prepare food (i.e., food workers) and on 

the environments in which the food is 

prepared (i.e., retail food establishment 

kitchens). Thus, data collection methods 

for this generic package include: (1) 

Manager and worker interviews/

surveys, and (2) observation of kitchen 

environments. Both methods allow data 

collection on food safety practices and 

environmental factors associated with 

those practices. 

For each data collection, we will 

collect data in approximately 47 retail 

food establishments per site. Thus, there 

will be approximately 376 

establishments per data collection (an 

estimated 8 sites × 47 establishments). 

We expect a manager/establishment 


tkelley on DSK3SPTVN1PROD with NOTICES
1506 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 

response rate of approximately 60 

percent; thus, we will need to attempt 

to recruit 627 managers/establishments 

via telephone in order to meet our goal 

of 376 establishments. Each manager 

will respond to the recruiting script 

only once for approximately 3 minutes. 

Thus, the maximum burden for the 

manager recruiting attempts will be 

31.35 hours (627 managers × 3 minutes). 

We will collect interview/survey data 

from a manager in each establishment. 

Each manager will respond only once 

for approximately 30 minutes. Thus, the 

maximum burden for the manager 

interview/survey will be 188 hours (376 

managers × 30 minutes). In total, the 

average burden for managers will be 

219.35 hours (31.35 hours for recruiting 

plus 188 hours for the interview/

survey). 

For each data collection, we will 

recruit a worker from each participating 

establishment to provide interview/

survey data. Each worker will respond 

to the recruiting script only once for 

approximately 3 minutes. Thus, the 

maximum burden for the worker 

recruiting attempts will be 18.8 hours 

(376 workers × 3 minutes). We expect a 

worker response rate of 90 percent (339 

workers). Each worker will respond 

only once for approximately 10 minutes. 

Thus, the maximum burden for the 

worker interview/survey will be 56.5 

hours (339 workers × 10 minutes). In 

total, the average burden per worker 

response will be 75.3 hours (18.8 hours 

for recruiting + 56.5 hours for the 

interview/survey). 

There is no cost to respondents other 

than their time. The total estimated 

annual burden for the data collection 

will be 295 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Retail managers ............ Manager Telephone Recruiting Script ................. 627 1 3/60 31 

Retail managers ............ Manager Interview/survey ................................... 376 1 30/60 188 

Retail food workers ........ Worker Recruiting Script ..................................... 376 1 3/60 19 

Retail food workers ........ Worker Interview/survey ...................................... 339 1 10/60 57 

Total ........................ ......................................................................... 295 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–00241 Filed 1–9–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0543] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Waiver of In Vivo 

Demonstration of Bioequivalence of 

Animal Drugs in Soluble Powder Oral 

Dosage Form Products and Type A 

Medicated Articles 

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 

the current burden hours on regulated 

industry of complying with the 

guidance underlying this collection of 

information. 

DATES: Submit electronic or written 

comments on the collection of 

information by March 13, 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. 


tkelley on DSK3SPTVN1PROD with NOTICES