[Federal Register Volume 73, Number 92 (Monday, May 12, 2008)]
[Notices]
[Pages 26998-26999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10467]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0271]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Consumer Survey on the Impact of Perceptions of the 
2006 Spinach Recall on Current Spinach Consumption

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 a proposed survey of how consumer 
perceptions of the 2006 spinach recall affect their current spinach 
consumption behaviors.

DATES:  Submit written or electronic comments on the collection of 
information by July 11, 2008.

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:  Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Consumer Survey on the Impact of Perceptions of the 2006 Spinach Recall 
on Current Spinach Consumption

    Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research 
relating to foods and to conduct educational and public information 
programs relating to the safety of the Nation's food supply. Under this 
authority, FDA is planning to conduct a consumer survey to assess how 
current perceptions of the 2006 spinach recall affect attitudes toward, 
and decisionmaking regarding, current spinach consumption. FDA will use 
the study to evaluate how its communications about the 2006 spinach 
recall affected consumers. In particular, FDA plans to evaluate the 
effects of emotions and cognition associated with consumer recollection 
of the 2006 spinach outbreak on current spinach consumption behavior.
    In September 2006, the United States experienced an outbreak of E. 
coli 0157:H7 infections in several States. Outbreak investigation by 
the Centers for Disease Control and Prevention, FDA, and Federal, 
State, and local partners linked the E. coli 0157:H7 to bagged fresh 
spinach that was sold nationwide (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01593.html). On September 14, 2006, FDA held a press 
teleconference and issued a press release alerting consumers about the 
outbreak (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01450.html). In 
addition to warning of the seriousness of the outbreak, the press 
release advised that consumers ``not eat bagged fresh spinach at this 
time.'' On September 16, 2006, FDA expanded its advice to consumers, 
advising them ``to not eat fresh spinach or fresh spinach-containing 
products until further notice'' (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01452.html). Finally, FDA reported in its September 22, 2006, 
press statement that spinach grown outside the limited geographical 
area to which the outbreak had been traced was not implicated in the 
outbreak and could be consumed (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01462.html). This report stated, ``The public can be confident 
that spinach grown in the non-implicated areas can be consumed. Other 
produce grown in these counties is not implicated in this outbreak. 
Processed spinach (e.g., frozen and canned spinach) is also not 
implicated in this outbreak.''
    Market research has shown that the 2006 fresh spinach recall had a 
tremendous economic impact on the spinach industry, as retail sales 
values continued to lag for months after the recall was over (http://www.ers.usda.gov/AmberWaves/June07/Features/Spinach.htm). Consumer 
confidence in the product has been blamed for the slow recovery.
    The survey will be used to gauge whether and how FDA and media 
communication about the recall affected consumers' enduring emotional 
and cognitive perceptions about the product, and whether or not these 
perceptions have an impact on their current spinach consumption. 
Findings from this study will be used to help FDA more effectively 
communicate with consumers.
    The data will be collected using a Web-based questionnaire. A pool 
of 35,000 people will be screened (through self-report) on current and 
past fresh spinach consumption. A random sample of 1,000 consumers will 
be selected.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 26999]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                       No. of         Annual Frequency       Total Annual        Hours per
 Questionnaire      Respondents         per Response          Responses          Response         Total Hours
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Screener                    35,000                     1             35,000            0.0055              192.5
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Survey                       1,000                     1              1,000            0.167               167
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Total                                                                                                      359.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's burden estimate is based on prior experience with consumer 
surveys that are similar to this proposed survey.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10467 Filed 5-9-08; 8:45 am]
BILLING CODE 4160-01-S