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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2011-N-0263]
 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 
                        ( print page 21380)
                        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 over-attribution 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 
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                    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 hoursCognitive Interview Recruitment
25
1
25
5/60
2Cognitive Interviews
10
1
10
1
10Consumer Panel Screener
800
1
800
2/60
24Grower Screener
360
1
360
2/60
11Retailer Screener
360
1
360
2/60
11Pre-tests
24
1
24
10/60
5Experiment
900
1
900
10/60
153Total




2161
                         There are no capital costs or operating and maintenance costs associated with this collection of information.2
                         Burden 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