65406 Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 U.S.C. 393(d)(2)(D) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Gatekeeper Reviews ............................................................ 400 1 400 0.50 200 

Omnibus Surveys ................................................................. 2,400 1 2,400 0.17 408 

Total (General Public) .......................................................... 16,448 ........................ 16,448 ........................ 2,860 

Veterinarian/Scientific Expert Focus Group Interviews ....... 288 1 288 0.75 216 

Total (Veterinarians/Scientific Experts) ................................ 288 1 288 ........................ 216 

Total (Overall) ............................................................... 16,736 1 16,736 ........................ 3,076 

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

2These are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 

number. 

Annually, FDA projects about 30 

studies with 16,736 respondents, using 

a variety of research methods and 

lasting an average of 0.17 hours each 

(varying from 0.08–1.5 hours). 

Dated: October 28, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26141 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Safety 

Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

4, 2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0345. Also 

include the FDA 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 Road, COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Safety Survey—(OMB Control 

Number 0910–0345)—Reinstatement 

I. Background 

Under section 903(b)(2) of the Federal 

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

393(b)(2)), we are authorized to conduct 

research relating to foods and to 

conduct educational and public 

information programs relating to the 

safety of the nation’s food supply. The 

Food Safety Survey measures 

consumers’ knowledge, attitudes, and 

beliefs about food safety. Previous 

versions of the survey were collected in 

1988, 1993, 1998, 2001, 2006, and 2010. 

Data from the previous Food Safety 

Surveys and from this proposed survey 

will be used to evaluate two Healthy 

People 2020 objectives: (1) Increase the 

proportion of consumers who follow 

key food safety practices (Objective FS– 

5) and (2) reduce severe allergic 

reactions to food among adults with a 

food allergy diagnosis (Objective FS–4) 

(Ref. 1). Data from this survey will also 

be used to measure progress toward the 

United States Department of 

Agriculture’s Food Safety Inspection 

Service’s Fiscal Year 2011-Fiscal Year 

2016 Strategic Plan goal of ensuring 

that, ‘‘Consumers, including vulnerable 

and underserved populations, adopt 

food safety best practices’’ (Ref. 2). 

Additionally, Food Safety Survey data 

are used to measure trends in consumer 

food safety habits including hand and 

cutting board washing, cooking 

practices, and use of food thermometers. 

Finally, data are used to evaluate 

educational messages and to inform 

policymakers about consumer attitudes 

about technologies such as food 

irradiation and biotechnology. 

The proposed Food Safety Survey will 

contain many of the same questions and 

topics as previous Food Safety Surveys 

to facilitate measuring trends in food 

safety knowledge, attitudes, and 

behaviors over time. The proposed 

survey will also be updated to explore 

emerging consumer food safety topics 

and expand understanding of previously 

asked topics. For example, recent papers 

in both the United States (Ref. 3) and 

Europe (Refs. 4 and 5) have pointed to 

changing epidemiology of listeriosis 

where adults over 60 years old have the 

highest rates of the illness. One reason 

for the increase in listeriosis rates 

among those over 60 years old could be 

increasing host susceptibility due to 

widened use of immunocompromising 

medications. We plan to include 

questions on the proposed survey to 

document the proportion of those over 

60 years old who self-report taking a 

defined list of major 

immunocompromising medications. In 

conjunction with our established 

questions about safe food handling and 

eating potentially risky foods, the 

additional questions will expand our 

understanding of listeriosis among those 

over 60. Other new topics planned to be 

covered on the survey include: 

Consumer understanding of 

mechanically tenderized beef, 

awareness of foodborne pathogens such 

as Toxoplasma gondii, and awareness of 

the risks associated with eating raw 

sprouts. 

The methods for the proposed Food 

Safety Survey will be largely the same 

as those used with the previous Food 

Safety Surveys. One major difference is 

that, unlike the data collection mode for 

previous Food Safety Surveys that used 

only land telephone lines, the proposed 

survey will include cell phones in 

addition to landlines. A nationally 

representative sample of 4,000 adults 


rmajette on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 65407 

(2,400 landline and 1,600 cell phone) 

will be selected at random for the 

telephone interviews. The survey will 

also include an oversample of Hispanics 

and Blacks to ensure a minimum of 400 

each. Additionally, 50 non-respondents 

will be asked to participate in a short 

version of the survey from which we 

will conduct a non-response analysis. 

Participation in the survey will be 

voluntary. Cognitive interviews and a 

pre-test will be conducted prior to 

fielding the survey. 

In the Federal Register of November 

1, 2013 (78 FR 65661), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received two letters in 

response to the notice, each containing 

one comment. The comments, and our 

responses, are discussed in the 

following paragraphs. For ease of 

reading, we preface each comment with 

a numbered ‘‘Comment’’; and each 

response by a corresponding numbered 

‘‘Response.’’ We have numbered each 

comment to help distinguish between 

different topics. The number assigned to 

each comment is for organizational 

purposes only and does not signify the 

comment’s value, or importance, or the 

order in which it was received. 

(Comment 1) One comment asked if a 

sample size of 4,000 was sufficient for 

this study, and suggested that FDA work 

with the Centers for Disease Control 

(CDC) on questions related to 

Toxoplasma gondii. 

(Response 1) We believe that a sample 

size of 4,000 adults is sufficient for this 

study since this study evaluates 

consumer knowledge, attitudes, and 

perceptions related to food safety. It is 

not a clinical study looking at the effects 

of Toxoplasma gondii in the U.S. 

population. We consult with our 

Federal partners, including the CDC and 

the U.S. Department of Agriculture to 

make sure this survey meets their needs. 

(Comment 2) One comment suggested 

that we add questions to the survey 

about preparing offals at home, washing 

raw poultry and meat, and cooking 

turkeys in the oven overnight. 

(Response 2) We agree that these are 

interesting additional topics and have 

added questions about washing raw 

poultry and cooking turkeys to the 

survey. Due to space constraints, we are 

unable to add questions about preparing 

offals at home to the survey 

questionnaire. This topic will be 

considered for future research. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Cognitive interview screener .................................... 75 1 75 0.083 (5 minutes) ...... 6 

Cognitive interview ................................................... 9 1 9 1 ................................ 9 

Pretest screener ....................................................... 45 1 45 0.0167 (1 minute) ...... 1 

Pretest ...................................................................... 18 1 18 0.33 (20 minutes) ...... 6 

Survey screener ....................................................... 10,000 1 10,000 0.0167 (1 minute) ...... 167 

Survey ...................................................................... 4,000 1 4,000 0.33 (20 minutes) ...... 1,320 

Non-response survey screener ................................ 125 1 125 0.0167 (1 minute) ...... 2 

Non-response survey ............................................... 50 1 50 0.167 (10 minutes) .... 8 

Total .................................................................. ........................ ........................ ........................ .................................... 1,519 

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

We base our estimate of the number 

of respondents and the average burden 

per response on our experience with 

previous Food Safety Surveys. We will 

use a cognitive interview screener with 

75 individuals to recruit prospective 

interview participants. We estimate that 

it will take a screener respondent 

approximately 5 minutes (0.083 hours) 

to complete the cognitive interview 

screener, for a total of 6 hours, rounded 

down from 6.225 hours. We will 

conduct cognitive interviews with nine 

participants. We estimate that it will 

take a participant approximately 1 hour 

to complete the interview, for a total of 

9 hours. Prior to the administration of 

the Food Safety Survey, we plan to 

conduct a pretest to identify and resolve 

potential survey administration 

problems. We will use a pretest screener 

with 45 individuals; we estimate that it 

will take a respondent approximately 1 

minute (0.0167 hours) to complete the 

pretest screener, for a total of 1 hour, 

rounded up from 0.7515 hours. The 

pretest will be conducted with 18 

participants; we estimate that it will 

take a participant 20 minutes (0.33 

hours) to complete the pretest, for a total 

of 6 hours, rounded up from 5.94 hours. 

We will use a survey screener to select 

an eligible adult respondent in each 

household reached by landline and cell 

phone telephone numbers to participate 

in the survey. A total of 10,000 

individuals in the 50 states and the 

District of Columbia will be screened by 

telephone. We estimate that it will take 

a respondent 1 minute (0.0167 hours) to 

complete the screening, for a total of 167 

hours. We estimate that 4,000 eligible 

adults will participate in the survey, 

each taking 20 minutes (0.33 hours), for 

a total of 1,320 hours. Additionally, we 

will administer a non-response survey 

using a short version of the survey from 

which we will conduct a non-response 

analysis. We will use a non-response 

survey screener with 125 individuals; 

we estimate that it will take a 

respondent approximately 1 minute 

(0.0167 hours) to complete the nonresponse survey screener, for a total of 

2 hours, rounded down from 2.0875 

hours. The non-response survey will be 

conducted with 50 participants; we 

estimate that it will take a participant 10 

minutes (0.167 hours) to complete the 

non-response survey, for a total of 8 

hours, rounded down from 8.35 hours. 

This is a correction to our previous 

estimate of 5 hours to complete the nonresponse survey. Thus, the total 

estimated burden is 1,519 hours, which 

incorporates the correction of the 

estimate to complete the non-response 

survey. 

II. References 

1. U.S. Department of Health and Human 

Services, ‘‘Healthy People 2020— 

Improving the Lives of Americans,’’ July 

30, 2013. Available at http://

www.healthypeople.gov/2020/

default.aspx. 

2. U.S. Department of Agriculture, Food 

Safety Inspection Service, ‘‘Strategic 

Plan FY 2011–2016,’’ April 6, 2012. 

Available at http://www.fsis.usda.gov/

wps/portal/informational/aboutfsis/

strategic-planning/fy-2011-2016- 

strategic-plan/ct_index. 

3. Pouillot, R., K. Hoelzer, K. A. Jackson, et 

al. ‘‘Relative Risk of Listeriosis in 

Foodborne Diseases Active Surveillance 


rmajette on DSK3VPTVN1PROD with NOTICES
65408 Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 

Network (FoodNet) Sites According to 

Age, Pregnancy, and Ethnicity,’’ Clinical 

Infectious Diseases, 54(S5): S401–410, 

2012. 

4. Goulet, V., C. Hedberg, A. Le Monnier, et 

al. ‘‘Increasing Incidence of Listeriosis in 

France and other European Countries,’’ 

Emerging Infectious Diseases, 14(5): 734– 

740, 2008. 

5. Mun ̃ oz, P., L. Rojas, E. Bunsow, et al. 

‘‘Listeriosis: An Emerging Public Health 

Problem Especially Among the Elderly,’’ 

Journal of Infection, 64: 19–33, 2012. 

Dated: October 29, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26144 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0312] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Extralabel Drug 

Use in Animals 

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 reporting requirements associated 

with extralabel drug use in animals. 

DATES: Submit electronic or written 

comments on the collection of 

information by January 5, 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. 

Extralabel Drug Use in Animals—21 

CFR 530 (OMB Control Number—0910– 

0325)—Extension 

The Animal Medicinal Drug Use 

Clarification Act of 1994 allows a 

veterinarian to prescribe the extralabel 

use of approved new animal drugs. 

Also, it permits FDA, if it finds that 

there is a reasonable probability that the 

extralabel use of an animal drug may 

present a risk to the public health, to 

establish a safe level for a residue from 

the extralabel use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. 

Although to date we have not 

established a safe level for a residue 

from the extralabel use of any new 

animal drug and, therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal Agencies, academia, or 

individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

530.22(b) .............................................................................. 2 1 2 4,160 8,320 

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


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