Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21379 

Request for Designation as Country Not 

Subject to the Restrictions Applicable to 

Human Food and Cosmetics 

Manufactured From, Processed With, or 

Otherwise Containing, Material From 

Cattle—21 CFR 189.5 and 700.27 (OMB 

Control Number 0910–0623—Extension) 

Section 801(a) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 381(a)) provides requirements 

with regard to imported food and 

cosmetics and provides for refusal of 

admission into the United States of 

human food and cosmetics that appear 

to be adulterated. Section 701(b) of the 

FD&C Act (21 U.S.C. 371(b)) authorizes 

the Secretaries of Treasury and Health 

and Human Services to jointly prescribe 

regulations for the efficient enforcement 

of section 801 of the FD&C Act. To 

address the potential risk of BSE in 

human food and cosmetics, FDA 

regulations in §§ 189.5 and 700.27 (21 

CFR 189.5 and 700.27) designate certain 

materials from cattle as ‘‘prohibited 

cattle materials,’’ including specified 

risk materials, the small intestine of 

cattle not otherwise excluded from 

being a prohibited cattle material, 

material from nonambulatory disabled 

cattle, and mechanically separated (MS) 

(Beef). Under the regulations no human 

food or cosmetic may be manufactured 

from, processed with, or otherwise 

contain prohibited cattle materials. 

However, the Agency may designate a 

country from which cattle materials 

inspected and passed for human 

consumption are not considered 

prohibited cattle materials and their use 

does not render a human food or 

cosmetic adulterated. 

Sections 189.5(e) and 700.27(e) 

provide that a country seeking to be so 

designated must send a written request 

to the Director, Center for Food Safety 

and Applied Nutrition (CFSAN). The 

information the country is required to 

submit includes information about a 

country’s BSE case history, risk factors, 

measures to prevent the introduction 

and transmission of BSE, and other 

information relevant to determining 

whether specified risk materials, the 

small intestine of cattle not otherwise 

excluded from being a prohibited cattle 

material, material from nonambulatory 

disabled cattle, or MS (Beef) from the 

country seeking designation should be 

considered prohibited cattle materials. 

FDA uses the information to determine 

whether to grant a request for 

designation, and whether to impose 

conditions if a request is granted. 

Sections 189.5 and 700.27 further 

state that countries that have been 

designated under §§ 189.5(e) and 

700.27(e) will be subject to future 

review by FDA to determine whether 

designation remains appropriate. As 

part of this process, FDA may ask 

designated countries to confirm that 

their BSE situation and the information 

submitted by them in support of their 

original application remain unchanged. 

FDA may revoke a country’s designation 

if FDA determines that it is no longer 

appropriate. Therefore, designated 

countries may respond to periodic 

requests by FDA by submitting 

information to confirm that their 

designation remains appropriate. FDA 

uses the information to ensure that their 

designation remains appropriate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

§§ 189.5 and 700.27— request for designation 1 1 1 80 80 

§§ 189.5(e) and 700.27(e)—response to request for review by FDA .............................. 1 1 1 26 26 

Total .......................................................... ............................ ............................ ............................ ............................ 106 

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

This estimate is based on FDA’s 

experience and the average number of 

requests for designation under §§ 189.5 

and 700.27 received in the past 3 years. 

FDA received one request for 

designation in 2009 and one in 2010. 

Based on this experience, FDA estimates 

the annual number of new requests for 

designation will be 1. FDA estimates 

that preparing the information required 

by §§ 189.5 and 700.27 and submitting 

it to the Agency in the form of a written 

request to the Director, CFSAN will 

require a burden of approximately 80 

hours per request. Thus, the annual 

burden for new requests for designation 

is estimated to be 80 hours, as shown in 

table 1, row 1 of this document. 

Under §§ 189.5(e) and 700.27(e), 

designated countries are subject to 

future review by FDA and may respond 

to periodic requests by FDA by 

submitting information to confirm that 

their designation remains appropriate. 

In the last 3 years, FDA has not 

requested any reviews. Thus, the 

Agency estimates that one or fewer will 

occur annually in the future. We 

estimate that the designated country 

undergoing a review in the future will 

need one third the time it took 

preparing its request for designation to 

respond to FDA’s request for review, or 

26 hours (80 hours x 0.33 = 26.4 hours, 

rounded to 26). The annual burden for 

reviews is estimated to be 26 hours, as 

shown in table 1, row 2 of this 

document. The total annual burden for 

this information collection is estimated 

to be 106 hours. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9154 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0263] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experiment To 

Evaluate Risk Perceptions of Produce 

Growers, Food Retailers, and 

Consumers After a Food Recall 

Resulting From a Foodborne Illness 

Outbreak 

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 


srobinson on DSKHWCL6B1PROD with NOTICES
21380 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

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 

‘‘Experiment to Evaluate Risk 

Perceptions of Produce Growers, Food 

Retailers, and Consumers After a Food 

Recall Resulting From a Foodborne 

Illness Outbreak.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 14, 2011. 

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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Experiment To Evaluate Risk 

Perceptions of Produce Growers, Food 

Retailers, and Consumers After a Food 

Recall Resulting From a Foodborne 

Illness Outbreak—(OMB Control 

Number 0910—NEW) 

This proposed collection of 

information entitled ‘‘Experiment to 

Evaluate Risk Perceptions of Produce 

Growers, Food Retailers, and Consumers 

After a Food Recall Resulting From a 

Foodborne Illness Outbreak’’ will be 

conducted under a cooperative 

agreement between the Joint Institute for 

Food Safety and Applied Nutrition 

(JIFSAN) and the Center for Risk 

Communication Research (CRCR) at the 

University of Maryland. JIFSAN was 

established in 1996 and is a public and 

private partnership between FDA and 

the University of Maryland. The CRCR 

will design and administer the study. 

FDA is requesting OMB approval 

under the PRA for the CRCR to conduct 

research with produce growers, food 

retailers, and consumers to gain 

information about these groups’ risk 

perceptions associated with produce 

that has recently been subject to a food 

recall resulting from a foodborne illness 

outbreak. The purpose of this research 

is to help FDA better understand 

whether the magnitude and duration of 

the decline in commodity consumption 

following food recalls can be partly 

explained by grower and retailer 

speculations and projections about 

consumers’ attitudes toward food recalls 

resulting from foodborne illness 

outbreaks. This research will be used to 

assess how grower, retailer, and 

consumer perceptions, attitudes, 

knowledge, and beliefs affect market 

recovery after a hypothetical fresh 

spinach recall. 

Epidemiologists define foodborne 

illness outbreaks as two or more cases 

of a similar illness resulting from the 

ingestion of a common food (Ref. 1). 

Because many foodborne illness cases 

are mild, most outbreaks are never 

recognized or brought to the attention of 

public health authorities. When the 

outbreaks are large in scale or cause 

hospitalization, serious illness, or death, 

public health officials will inform the 

public in order to try to stop the spread 

of disease. A food recall can occur when 

a particular food in the marketplace is 

found to have a known contaminant, 

because either people have become 

sickened by it or pathogen testing has 

revealed contamination (Ref. 2). The 

purpose of a food recall is to rid retail 

establishments of the product and to 

inform consumers that they should 

discard the product if they have it in 

their homes. Although the purpose of a 

food recall is to keep consumers from 

becoming ill, food recalls can be costly 

to all sectors of the food distribution 

chain (Ref. 3). The goal of the proposed 

project is to test, by experimental study, 

whether the psychological tendency 

called ‘‘attribution error,’’ contributes to 

unnecessarily prolonging the economic 

effects of a food recall. ‘‘Attribution 

error’’ is the tendency people have of 

overestimating others’ negative response 

to situations compared to their own 

response. If industry decisionmakers’ 

measures of consumer response are 

biased by ‘‘attribution error,’’ industry 

could be contributing to its own slow 

recovery after a food recall. 

When a widespread foodborne illness 

outbreak results in a food recall, the 

product can be out of the marketplace 

for an extended period of time; this 

occurred when fresh, bagged spinach 

was recalled in 2006 (Ref. 3). Tomatoes 

were also less available following the 

Salmonella Saintpaul outbreak in 2008 

(Ref. 4). Although growers and retailers 

want to provide safe foods, decisions 

surrounding production, wholesale, and 

retail sales forecasting in response to a 

food recall affects how quickly the food 

is again available for consumption. We 

hypothesize that industry’s overattribution of consumers’ fear of the 

food after such a food recall would 

result in the food being kept off of the 

market longer than necessary. 

The CRCR plans to conduct an 

experiment using a Web-based 

questionnaire. The center will use a 

convenience sample of 900 participants 

(180 growers, 180 retailers, 540 

consumers) drawn from industry 

networks (for the growers and retailers), 

and a Web-based panel of U.S. 

households (for the consumers). 

Participation in the study is voluntary. 

This study will help FDA better 

understand the reasons for the time 

between a food recall resulting from a 

foodborne illness outbreak and market 

recovery. In order to understand the 

complexities of market recovery 

process, the CRCR will compare 

understandings and reactions of 

growers, retailers, and consumers to a 

hypothetical food recall resulting from a 

hypothetical foodborne illness outbreak. 

To make this comparison, individuals in 

each group will be assigned to one of 

the following experimental conditions 

(consisting of vignettes in the form of 

news articles on a hypothetical food 

recall): An ‘‘anger’’ scenario, a ‘‘fear’’ 

scenario, or a ‘‘control’’ scenario. After 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21381 

reading the news article, participants 

will complete a questionnaire assessing 

their emotional response, appraisals, 

attribution of responsibility, perceptions 

about the safety of the affected produce, 

intentions to grow, sell, or buy the 

affected produce, perceived probability 

of a repeat event, and a measure of their 

innate ability to effectively respond to 

the information in the article. 

To help design and refine the 

questionnaire, we will recruit 25 

participants in order to conduct 10 

cognitive interviews. We estimate 

cognitive interview recruitment will 

take 5 minutes (0.083 hours), for a total 

of 2 hours. The cognitive interviews are 

estimated at 1 hour per response for a 

total of 10 hours for the cognitive 

interview activities. We expect to send 

screeners to 800 members of a consumer 

panel, each taking 2 minutes (0.03 

hours) to complete, for a total of 24 

hours for the consumer panel screener 

activity. We also expect to administer 

360 screeners to growers and retailers, 

each taking 2 minutes (0.033 hours) to 

complete, for a total of 24 hours (11 + 

11 = 22). Twenty-four participants (20 

consumers, 2 growers, 2 retailers) will 

complete the pre-test. Each pre-test will 

take 10 minutes (0.17 hours) for a total 

of 5 hours for the pre-test activity. We 

estimate that 900 individuals (540 

consumers, 180 growers, and 180 

retailers) will complete the 

questionnaire for the experiment, each 

taking 10 minutes (0.17 hours) for a total 

of 153 hours for the experimental study 

activities. The estimated total hour 

burden of the collection of information 

is 215 hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

(in hours) 2

Total hours 

Cognitive Interview Recruitment .......................................... 25 1 25 5/60 2 

Cognitive Interviews ............................................................. 10 1 10 1 10 

Consumer Panel Screener .................................................. 800 1 800 2/60 24 

Grower Screener .................................................................. 360 1 360 2/60 11 

Retailer Screener ................................................................. 360 1 360 2/60 11 

Pre-tests ............................................................................... 24 1 24 10/60 5 

Experiment ........................................................................... 900 1 900 10/60 153 

Total .............................................................................. ........................ ........................ ........................ ........................ 216 

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

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. 

II. References 

11. Olsen, S., L. MacKinon, et al., 

‘‘Surveillance for Foodborne Disease 

Outbreaks—United States, 1993 to1997,’’ 

Morbidity and Mortality Weekly Report 

49(SS01), pp. 1 through 51, 2000. 

2. FDA 101: Product Recalls—From First 

Alert to Effectiveness Checks, Available 

at http://www.fda.gov/ForConsumers/ 

ConsumerUpdates/ucm049070.htm. 

3. Calvin, L., ‘‘Outbreak Linked to Spinach 

Forces Reassessment of Food Safety 

Practices,’’ Amber Waves 5(3), pp. 24 

through 31, 2007. 

4. Lucier, G. and R. Dettmann, ‘‘Vegetables 

and Melons Outlook,’’ A Report From the 

United States Department of Agriculture, 

Economic Research Service, VGS–327, 

June 26, 2008. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9155 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0241] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ATRYN; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of March 21, 2011 (76 FR 

15323). The document announced the 

determination of the regulatory review 

period for ATRYN. The document was 

published with an incorrect docket 

number. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Office of Policy, Planning 

and Budget, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 3208, Silver Spring, 

MD 20993–0002, 301–796–9138. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2011–6509, appearing on page 15323, in 

the Federal Register of Monday, March 

21, 2011, the following correction is 

made: 

1. On page 15323, in the first column, 

in the Docket No. heading, ‘‘[Docket No. 

FDA–2010–E–0241]’’ is corrected to read 

‘‘[Docket No. FDA–2009–E–0241]’’. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9153 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Pediatric 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: Pediatric 

Advisory Committee. 


srobinson on DSKHWCL6B1PROD with NOTICES