[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59558-59560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 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 ``Real Time'' surveys of consumers' 
knowledge, perceptions, and beliefs concerning foodborne illness 
outbreaks or food recalls.

DATES:  Submit written or electronic comments on the collection of 
information by January 19, 2010.

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 (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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.

``Real Time'' Surveys of Consumers' Knowledge, Perceptions, and 
Reported Behavior Concerning Foodborne Illness Outbreaks or Food 
Recalls--Federal Food, Drug, and Cosmetic Act/Section 903(d)(2)(C)--
(OMB Control Number 0910-NEW)

I. Description

    FDA communicates with consumers about food recalls directly, on 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,

[[Page 59559]]

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 0157: 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 to its broad statutory 
authority, set forth in section 903(b)(2) of the Federal Food, Drug, 
and Cosmetic 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.
    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  per       Total Annual          Hours per
                Portion of Study                     Respondents             Response               Responses            Response         Total Hours
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Screener                                                     30,000                        1                30,000              .0055                165
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Pretest                                                          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.

    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 pretest of the first survey with 
40 respondents; we estimate that it will take a respondent 10 minutes 
(0.167 hours) to complete the pretest, 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 annual reporting burden is 2,677 hours. FDA's burden 
estimate is based on prior experience with consumer surveys that are 
similar to these.

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., S. Condry, M. Nucci, and W. Hallman, ``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., C. Cuite, and N. Hooker, ``Consumer Responses to 
Food Recalls: 2009 National Survey Report,'' Publication number RR-
0109-018, New Brunswick, New Jersey: 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).


[[Page 59560]]


    Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27659 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S