[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23773-23775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0535]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; ``Real Time'' Surveys 
of Consumers' Knowledge, Perceptions, and Reported Behavior Concerning 
Foodborne Illness Outbreaks or Food Recalls

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 [email protected]. 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.

[[Page 23774]]


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\
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                                                        No. of         Annual Frequency        Total Annual
                    Activity                         Respondents         per Response            Responses        Hours per Response      Total Hours
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Screener                                                     30,000                     1                30,000                 .0055                165
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Pre-test                                                         40                     1                    40                  .167                  7
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Survey                                                       15,000                     1                15,000                  .167              2,505
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Total                                             .................  ....................  ....................  ....................              2,677
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 23775]]

    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