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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2010-N-0267]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) 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 May 16, 2011.
 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 e-mailed to 
                        *oira_submission@omb.eop.gov.*
                         All comments should be identified with the OMB control number 0910-new and “Survey on Consumers' Emotional and Cognitive Reactions to Food Recalls.” Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of  Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.


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. Survey on Consumers' Emotional and Cognitive Reactions to Food Recalls—21 U.S.C. 393(d)(2)(C) (OMB Control Number 0910-NEW) I. Background The proposed “Survey on Consumers' Emotional and Cognitive Reactions to Food Recalls” 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 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 Center for Risk Communication Research will design and administer the study. The proposed study will assess consumers' emotional and cognitive recollection of certain food recalls and gauge how these recollections affect their current perceptions about food recalls and their inclination to adhere to future recommended food recall behaviors. Existing data show that many consumers do not take appropriate protective actions during a foodborne illness outbreak or food recall (Refs. 1 and 2). For example, 41 percent of U.S. consumers say they have never looked for any recalled product in their home (Ref. 2). Conversely, some consumers overreact to the announcement of a foodborne illness outbreak or food recall. In response to the 2006 fresh, bagged spinach recall which followed a 
                    ( print page 20991)
                    multistate outbreak of 
                    *Escherichia coli*
                     O157: H7 infections (Ref. 3), 18 percent of consumers said they stopped buying other bagged, fresh produce because of the spinach recall (Ref. 1). Research shows that emotion plays a large role in decisionmaking, and that individuals may not be conscious of its effects on their behavior (Ref. 4). For example, when people are angry they are likely to place blame, take action, and want justice to be served (Ref. 5). If a particular food recall engenders widespread anger and the anger is coupled with behavior that is less than desirable from a food safety or nutritional standpoint, it is possible that anger will be the lens through which future food recall situations are viewed, thus resulting in similar undesirable behaviors. Findings from this study will help FDA understand the emotional response to food recalls. This will help FDA to design more effective consumer food recall messages during and after a recall. FDA conducts research and educational and public information programs relating to food safety under its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 903(d)(2)(C), to conduct research relating to foods, drugs, cosmetics, and devices in carrying out the FD&C Act. FDA plans to survey U.S. consumers using a web-based panel of U.S. households to collect information on consumers' cognitive and emotional reaction to food recalls. The survey will query consumers on their recollection of food recalls within the past 5 years; attitude toward recalled foods; knowledge about particular food recalls; behavior during the food recall; and assessment and appraisals of susceptibility, severity, satisfaction, and self-efficacy. The data will be collected using an online survey. A pool of 10,000 consumers from a Web-based consumer panel will be screened for eligibility based on age (18+ years) and familiarity with recent food recalls. One thousand of eligible consumers will be randomly selected to participate in the survey. The results of the survey will not be used to generate population estimates. The estimated total hour burden of the collection of information is 354 hours (table 1 of this document). To help design and refine the questionnaire, the Center for Risk Communication Research will conduct cognitive interviews by screening 25 adult consumers in order to obtain 8 respondents for the cognitive interviews. Each screening is expected to take 5 minutes (0.083 hours) and each cognitive interview is expected to take 1 hour. The total for cognitive interview activities is 10 hours (2 hours + 8 hours). Subsequently, we will conduct pretests of the study questionnaire before it is administered. We expect that 100 invitations, each taking 2 minutes (0.033 hours), will need to be sent to adult members of the online consumer panel to have 40 of them complete a 10 minute (0.167 hours) pretest. The total for the pretest activities is 10 hours (3 hours + 7 hours). We estimate sending 10,000 survey screeners, each taking 1 minute (0.017 hours), to adult members of the online consumer panel to have 1,000 of them complete a 10 minute (0.167 hours) survey. The total for the survey activities is 337 hours (170 hours + 167 hours). The burden estimate for this study published in the 
                    **Federal Register**
                     of June 18, 2010 (75 FR 34745), has increased from 234 hours to 357 hours. The increase in burden hours represents the addition of cognitive interviews to the study design and correction of a math error. In the 
                    **Federal Register**
                     of June 18, 2010 (75 FR 34745), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two letters containing multiple comments in response to the notice. One letter contained comments outside the scope of the four collection of information topics on which the notice solicits comments and, thus, will not be addressed here. (Comment) One comment suggested that the survey should include consumers whose pets were sickened or had died because of mycotoxins in pet food that resulted in the 2004 pet food recall. (Response) FDA agrees that consumers who were affected by the 2004 pet food recall should be included as survey respondents. These consumers will be included if they are members of the online consumer panel from which the survey sample will be drawn and they are randomly selected from the panel. FDA does not believe that the affected population should be target-sampled because the study focuses on human food recalls rather than pet food recalls. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1
Portion of study
Number of 
                             respondents
Annual 
                             frequency per  
                             response
Total annual responses
Hours per response
Total hoursCognitive interview screener
25
1
25
5/60
2Cognitive interview
8
1
8
1/60
8Pretest screener
100
1
100
2/60
3Pretest
40
1
40
10/60
7Screener
10,000
1
10,000
1/60
170Survey
1,000
1
1,000
10/60
167Total




3571
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 II. References The following references have 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. 1. Cuite, C., Condry, S., Nucci, M., and Hallman, W., “Public Response to the Contaminated Spinach Recall of 2006,” Publication number RR-0107-013. New Brunswick, New Jersey: Rutgers, the State University of New Jersey, Food Policy Institute, 2007. 2. Hallman, W., Cuite, C., and Hooker, N., “Consumer Responses to Food Recalls: 2009 National Survey Report,” Publication number RR-0109-018. New Brunswick, New Jersey: Rutgers, the 
                    ( print page 20992)
                    State University of New Jersey, Food Policy Institute, 2009. 3. Acheson, D., “Outbreak of Escherichia coli 0157 Infections Associated with Fresh Spinach—United States, August-September 2006,” 2007. Available at 
                    *http://first.fda.gov/​cafdas/​documents/​Acheson_​Spinach_​Outbreak_​2006_​FDA_​pres.ppt.* 4. Han, S., Lerner, J.S., and Keltner, D., “Feelings and Consumer Decision Making: The Appraisal-Tendency Framework,” 
                    *Journal of Consumer Psychology,*
                     17(3), 158-168, 2007. 5. Lazurus, R.S., Emotion and Adaptation. New York: Oxford University Press, 1991. Dated: April 8, 2011. Leslie Kux, Acting Assistant Commissioner for Policy.


[FR Doc. 2011-8936 Filed 4-13-11; 8:45 am] BILLING CODE 4160-01-P