[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