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, 59558-59560 [E9-27659]
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Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
information in communications with
parents. NHLBI will also be able to
determine parents’ efficacy related to
the actions needed to promote their
children’s heart health, allocating
resources for the campaign to provide
support to overcome perceived barriers;
Frequency of Response: One-time
survey; Affected Public: Individuals or
households; and Type of Respondents:
Parents and caregivers of children ages
0–7. The annual reporting burden is as
follows: Estimated Number of
Respondents: 1,175; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours Per Response:
.167; and Estimated Total Annual
Burden Hours Requested: 196.23. There
are no Capital Costs, Operating Costs,
and/or Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Amy
Pianalto, National Heart, Lung, and
Blood Institute, NIH, 31 Center Drive,
Building 31A, Room 4A10, Bethesda,
MD 20892; or call non-toll-free number
301–594–2093 or e-mail request,
including your address, to
pianaltoa@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
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Dated: October 30, 2009.
Amy Pianalto,
Technical Writer, Office of Communications
and Legislative Activities, NHLBI, National
Institutes of Health.
[FR Doc. E9–27688 Filed 11–17–09; 8:45 am]
BILLING CODE 4140–01–P
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.
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 https://
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
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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,
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Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
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
59559
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:
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
TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN1
Portion of Study
No. of
Respondents
Screener
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
30,000
1
30,000
.0055
165
Pretest
40
1
40
.167
7
Survey
15,000
1
15,000
.167
2,505
Total
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1 There
2,677
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
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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.
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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, (https://first.fda.gov/cafdas/
documents/Acheson_Spinach_Outbreak_
2006_FDA_pres.ppt).
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59560
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27659 Filed 11–17–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
National Institutes of Health
[Docket No. FDA–2009–C–0543]
Government-Owned Inventions;
Availability for Licensing
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sauflon Pharmaceuticals Ltd.; Filing of
Color Additive Petition
Administration for Children and
Families
HHS.
AGENCY:
Administration on Children, Youth and
Families; Notice To Award One
Expansion Supplement Grant
AGENCY: Family and Youth Services
Bureau, ACYF, ACF, HHS.
ACTION: Notice to award one expansion
supplement grant.
mstockstill on DSKH9S0YB1PROD with NOTICES
CFDA Number: 93.592.
Legislative Authority: The Family
Violence Prevention and Services Act,
42 U.S.C. 10401 through 10421, as
extended by the Department of Health
and Human Services Appropriations
Act, 2009, Public Law 111–8.
Total Amount of Award: $225,000.
Project Period: September 30, 2009–
September 29, 2010.
SUMMARY: This notice announces the
award of an expansion supplement
grant to one grantee under the Family
and Youth Services Bureau (FYSB)/
Family Violence Prevention and
Services Program. The expansion
supplement award is made to the
Pennsylvania Coalition Against
Domestic Violence, Harrisburg, PA, a
technical assistance provider, to support
their capacity to provide technical
support and training to State and local
domestic violence advocates and social
service agencies. These efforts will
allow FYSB to support collaborative
work to enhance the capacity of
Temporary Assistance to Needy
Families (TANF) and other Federal
programs to provide assistance to
eligible victims of domestic violence.
FOR FURTHER INFORMATION CONTACT:
Marylouise Kelley, Ph.D., Director,
Family Violence Prevention and
Services Program, 1250 Maryland
Avenue, SW., Suite 8216, Washington,
DC 20024. Telephone: 202–104–5756 Email: Marylouise.kelley@acf.hhs.gov.
Dated: November 10, 2009.
Maiso L. Bryant,
Acting Commissioner, Administration on
Children, Youth and Families.
[FR Doc. E9–27667 Filed 11–17–09; 8:45 am]
BILLING CODE 4184–32–P
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ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that Sauflon Pharmaceuticals Ltd. has
filed a petition proposing that the color
additive regulations be amended to
provide for the safe use of disodium 1amino-4-[[4-[(2-bromo-1oxoallyl)amino]-2sulfonatophenyl]amino]-9,10-dihydro9,10-dioxoanthracene-2-sulfonate (CAS
Reg. No. 70209–99–3) as a color additive
in contact lenses.
FOR FURTHER INFORMATION CONTACT:
Raphael A. Davy, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1272.
Under the
Federal Food, Drug, and Cosmetic Act
(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),
notice is given that a color additive
petition (CAP 8C0287) has been filed by
Sauflon Pharmaceuticals Ltd., 49–53
York St., Twickenham, Middlesex, TW1
3LP, United Kingdom. The petition
proposes to amend the color additive
regulations in 21 CFR part 73, subpart
D, Medical Devices to provide for the
safe use of disodium 1-amino-4-[[4-[(2bromo-1-oxoallyl)amino]-2sulfonatophenyl]amino]-9,10-dihydro9,10-dioxoanthracene-2-sulfonate (CAS
Reg. No. 70209–99–3) as a color additive
in contact lenses.
The agency has determined under 21
CFR 25.32(l) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
SUPPLEMENTARY INFORMATION:
Dated: November 10, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E9–27629 Filed 11–17–09; 8:45 am]
BILLING CODE 4160–01–S
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AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
A Novel Treatment for Malarial
Infections
Description of Invention: The
inventions described herein are
antimalarial small molecule inhibitors
of the plasmodial surface anion channel
(PSAC), an essential nutrient acquisition
ion channel expressed on human
erythrocytes infected with malaria
parasites. These inhibitors were
discovered by high-throughput
screening of chemical libraries and
analysis of their ability to kill malaria
parasites in culture. Two separate
classes of inhibitors were found to work
synergistically in combination against
PSAC and killed malaria cultures at
markedly lower concentrations than
separately. These inhibitors have high
affinity and specificity for PSAC and
have acceptable cytotoxicity profiles.
Preliminary in vivo testing of these
compounds in a mouse malaria model is
currently ongoing.
Applications: Treatment of malarial
infections.
Advantages: Novel drug treatment for
malarial infections; Synergistic effect of
these compounds on PSAC.
Development Status: In vitro and in
vivo data can be provided upon request.
Market: Treatment of malarial
infection.
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]]>Agencies
[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59558-59560]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27659]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
Portion of Study Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener 30,000 1 30,000 .0055 165
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 40 1 40 .167 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey 15,000 1 15,000 .167 2,505
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 2,677
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, (https://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
