[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