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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2009-N-0535]
 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 June 3, 2010.
 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 title “‘Real Time’ Surveys of Consumers' Knowledge, Perceptions, and Reported Behavior Concerning Foodborne Illness Outbreaks or 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. “Real Time” Surveys of Consumers' Knowledge, Perceptions, and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls ( OMB Control No. 0910-NEW) I. Description FDA communicates with consumers about food recalls directly, at its own Web site, and through various mass media channels, such as television and newspapers, during a foodborne illness outbreak or food recall. In these communications, FDA typically identifies the implicated food, the symptoms of the foodborne illness at issue, any subpopulations at elevated risk of infection or illness, and protective measures individuals can or should take. The purpose of these communications is to provide consumers with information so they can protect themselves from potential health risks associated with an outbreak or food recall. Consumers also get information about an outbreak or recall from other sources, including other Federal and State agencies, industry, consumer groups, and the mass media, which may or may not relay FDA's public announcements. 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 multistate outbreak of 
                    *E. 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). Existing research also suggests that many consumers may not have correct knowledge about products subject to a given recall. For example, in a survey conducted 2 months after the onset of the 2006 spinach recall, one third of respondents did not know that, in addition to bagged spinach, fresh loose spinach was part of the recall, while 22 percent believed that frozen spinach was subject to the recall (it was not) (Refs. 1 and 3). In order for FDA to protect the public health during foodborne illness outbreaks or food recalls, the Agency needs timely information collected from consumers as the events unfold to ensure that consumers understand the extent of the incident and that they are taking appropriate actions. Results from the information collection will indicate to FDA whether the Agency should adjust its communications to help consumers react appropriately. 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 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 act. FDA plans to survey U.S. consumers using a Web-based panel of U.S. households to collect information on consumers' “real time” knowledge, perceptions, beliefs, and self-reported behaviors for up to five foodborne illness outbreaks or food recalls a year. Moreover, because the information environment during certain foodborne illness outbreaks or food recalls evolves as new information emerges, the Agency plans to field up to three waves of independent surveys per event (i.e., outbreak or recall). The surveys will query consumers on topics such as: (1) The products that are subject to the outbreak or recall, (2) the implicated pathogens, (3) the food vehicle of the outbreak or recall, and (4) how consumers can protect themselves. FDA plans to conduct the surveys soon after the onset of an outbreak or recall and whenever the Agency suspects that: (1) Messages are not reaching consumers, and/or (2) consumers do not understand the messages, and/or (3) consumers are not taking appropriate actions in response to the messaging. Collecting information quickly during a foodborne illness outbreak or food recall is important because erroneous perceptions or misinterpreted information about an outbreak or recall can impede consumer adoption of recommended protective behaviors. Criteria for selecting a particular foodborne illness outbreak or food recall for a survey will include a qualitative assessment of the salience of some or all of the following: The geographical dispersion of the event, the number of illnesses or deaths associated with it, the relative familiarity of the food product, the complexity of consumer precaution instructions, and the presence of national media focus. The Agency will use the survey results to help adjust its communication strategies and messages for foodborne illness outbreaks or food recalls, when needed. The results will not be used to develop population estimates. In the 
                    **Federal Register**
                     of November 18, 2009 (74 FR 59558), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden**1
Activity
No. of 
                             Respondents
Annual Frequency
                             per Response
Total Annual 
                             Responses
Hours per Response
Total HoursScreener
30,000
1
30,000
.0055
165Pre-test
40
1
40
.167
7Survey
15,000
1
15,000
.167
2,505Total




2,6771
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 
 
 Approximately 30,000 respondents of a Web-based consumer panel will be screened (3 waves (independent surveys)) for each of 5 incidents; 2,000 respondents per wave). We estimate that it will take a respondent 20 seconds (0.0055 hours) to complete the screening questions, for a total of 165 hours. We will conduct a pre-test of the first survey with 40 respondents; we estimate that it will take a respondent 10 minutes (0.167 hours) to complete the pre-test, for a total of 7 hours. Fifteen thousand (15,000) respondents will complete the surveys (3 waves (independent surveys)) for each of 5 incidents; 1,000 respondents per wave). We estimate that it will take a respondent 10 minutes (0.167 hours) to complete the survey, for a total of 2,505 hours. Thus, the total estimated burden is 2,677 hours. FDA's burden estimate is based on prior experience with consumer surveys that are similar to these. II. References 1. Cuite, C., S. Condry, M. Nucci, et al., “Public Response to the Contaminated Spinach Recall of 2006,” Publication no. RR-0107-013, New Brunswick, NJ: Rutgers, the State University of New Jersey, Food Policy Institute, 2007. 2. Hallman, W., C. Cuite, N. Hooker, “Consumer Responses to Food Recalls: 2009 National Survey Report,” Publication no. RR-0109-018, New Brunswick, NJ: Rutgers, the 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 (
                        *http://first.fda.gov/​cafdas/​documents/​Acheson_​Spinach_​Outbreak_​2006_​FDA_​pres.ppt*). Dated: April 28, 2010. Leslie Kux, Acting Assistant Commissioner for Policy.


[FR Doc. 2010-10357 Filed 5-3-10; 8:45 am] BILLING CODE 4160-01-S