Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experiment To Evaluate Risk Perceptions of Produce Growers, Food Retailers, and Consumers After a Food Recall Resulting From a Foodborne Illness Outbreak, 62810-62812 [2011-26131]
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62810
Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices
understandings. These roles and
responsibilities are as follows:
1. Sponsor/requester. The sponsor/
requester initiates consideration for
parallel review by submitting a
complete nomination as outlined
previously under ‘‘1. Nomination,’’ of
section II.C of this document entitled
‘‘Procedures.’’. Once a nomination has
been submitted, the sponsor/requester
should comply with all requirements
necessary for FDA review of a PMA or
de novo petition and CMS issuance of
an NCD including the submission of a
formal request for an NCD. The
Agencies request that a sponsor/
requester who wishes to withdraw from
the parallel review process notify the
FDA and CMS in writing before CMS’
formal opening of an NCD by the
posting of the NCD tracking sheet.
2. The FDA. FDA will provide a
secure and confidential nomination and
review process as outlined previously in
section II.C of this document. FDA will
initiate review of nominations for
parallel review by retrieving
applications from the secure mailbox,
and coordinating with CMS, on the
planning and implementation of the
parallel review process. FDA will
review PMAs and de novo petitions for
products that have been selected by the
Agencies for parallel review according
to the usual timeframes, procedures,
and review standards for PMA approval
and de novo classification.
3. The CMS. In addition to the
coverage review, CMS’s parallel review
roles include participating in the
nomination process as well as
coordinating with FDA regarding the
planning and implementation of the
parallel review process. During the
parallel review, CMS is responsible for
maintaining open communication
channels with FDA and the sponsor/
requester and for fulfilling its statutory
obligations concerning the NCD process.
mstockstill on DSK4VPTVN1PROD with NOTICES
E. Duration of the Pilot
The Agencies intend to accept
requests for participation in the pilot
program for parallel review for 2 years.
The Agencies may terminate the pilot
program before the close of the 2-year
period, or may extend the pilot program
beyond 2 years. The decisions will be
announced in the Federal Register.
F. Evaluation
The Agencies intend to use their
experience with the pilot program to
develop a parallel review program not
only for devices but also for drugs and
biological products. The Agencies
anticipate their experience with the
parallel review program for devices and
feedback from participants in the
VerDate Mar<15>2010
20:47 Oct 07, 2011
Jkt 226001
program will inform guidance for a
broader program applicable to all
medical products. The Agencies may
also determine that they should extend
or modify the parallel review pilot
program to continue their evaluation.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program) (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 21, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: September 21, 2011.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2011–25907 Filed 10–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0263]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experiment To
Evaluate Risk Perceptions of Produce
Growers, Food Retailers, and
Consumers After a Food Recall
Resulting From a Foodborne Illness
Outbreak
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
DATES: Fax written comments on the
collection of information by November
10, 2011.
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Experiment to Evaluate Risk
Perceptions of Produce Growers, Food
Retailers, and Consumers After a Food
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Recall Resulting From a Foodborne
Illness Outbreak.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., 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.
Experiment To Evaluate Risk
Perceptions of Produce Growers, Food
Retailers, and Consumers After a Food
Recall Resulting From a Foodborne
Illness Outbreak—(OMB Control
Number 0910—NEW)
I. Background
This proposed collection of
information entitled ‘‘Experiment to
Evaluate Risk Perceptions of Produce
Growers, Food Retailers, and Consumers
After a Food Recall Resulting From a
Foodborne Illness Outbreak’’ will be
conducted under a cooperative
agreement between the Joint Institute for
Food Safety and Applied Nutrition
(JIFSAN) and the Center for Risk
Communication Research (CRCR) at the
University of Maryland. JIFSAN was
established in 1996 and is a public and
private partnership between FDA and
the University of Maryland. The CRCR
will design and administer the study.
FDA is requesting OMB approval
under the PRA for the CRCR to conduct
research with produce growers, food
retailers, and consumers to gain
information about these groups’ risk
perceptions associated with produce
that has recently been subject to a food
recall resulting from a foodborne illness
outbreak. The purpose of this research
is to help FDA better understand
whether the magnitude and duration of
the decline in commodity consumption
following food recalls can be partly
explained by grower and retailer
speculations and projections about
consumers’ attitudes toward food recalls
resulting from foodborne illness
outbreaks. This research will be used to
assess how grower, retailer, and
consumer perceptions, attitudes,
knowledge, and beliefs affect market
recovery after a hypothetical fresh
spinach recall.
Epidemiologists define foodborne
illness outbreaks as two or more cases
of a similar illness resulting from the
ingestion of a common food (Ref. 1).
Because many foodborne illness cases
are mild, most outbreaks are never
E:\FR\FM\11OCN1.SGM
11OCN1
Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices
recognized or brought to the attention of
public health authorities. When the
outbreaks are large in scale or cause
hospitalization, serious illness, or death,
public health officials will inform the
public in order to try to stop the spread
of disease. A food recall can occur when
a particular food in the marketplace is
found to have a known contaminant
because either people have become
sickened by it or pathogen testing has
revealed contamination (Ref. 2). The
purpose of a food recall is to rid retail
establishments of the product and to
inform consumers that they should
discard the product if they have it in
their homes. Although the purpose of a
food recall is to keep consumers from
becoming ill, food recalls can be costly
to all sectors of the food distribution
chain (Ref. 3). The goal of the proposed
project is to test, by experimental study,
whether the psychological tendency
called ‘‘attribution error,’’ contributes to
unnecessarily prolonging the economic
effects of a food recall. ‘‘Attribution
error’’ is the tendency people have of
overestimating others’ negative response
to situations compared to their own
response. If industry decisionmakers’
measures of consumer response are
biased by ‘‘attribution error,’’ industry
could be contributing to its own slow
recovery after a food recall.
When a widespread foodborne illness
outbreak results in a food recall, the
product can be out of the marketplace
for an extended period of time; this
occurred when fresh, bagged spinach
was recalled in 2006 (Ref. 3). Tomatoes
were also less available following the
Salmonella Saintpaul outbreak in 2008
(Ref. 4). Although growers and retailers
want to provide safe foods, decisions
surrounding production, wholesale, and
retail sales forecasting in response to a
food recall affects how quickly the food
is again available for consumption. We
hypothesize that industry’s
overattribution of consumers’ fear of the
food after such a food recall would
result in the food being kept off of the
market longer than necessary.
The CRCR plans to conduct an
experiment using a Web-based
questionnaire. The center will use a
convenience sample of 900 participants
(180 growers, 180 retailers, 540
consumers) drawn from industry
networks (for the growers and retailers),
and a Web-based panel of U.S.
households (for the consumers).
Participation in the study is voluntary.
This study will help FDA better
understand the reasons for the time
between a food recall resulting from a
foodborne illness outbreak and market
recovery. In order to understand the
complexities of market recovery
process, the CRCR will compare
understandings and reactions of
growers, retailers, and consumers to a
hypothetical food recall resulting from a
hypothetical foodborne illness outbreak.
To make this comparison, individuals in
each group will be assigned to one of
the following experimental conditions
(consisting of vignettes in the form of
news articles on a hypothetical food
recall): An ‘‘anger’’ scenario, a ‘‘fear’’
scenario, or a ‘‘control’’ scenario. After
reading the news article, participants
will complete a questionnaire assessing
their emotional response; appraisals;
attribution of responsibility; perceptions
about the safety of the affected produce;
intentions to grow, sell, or buy the
affected produce; perceived probability
of a repeat event; and a measure of their
innate ability to effectively respond to
the information in the article.
To help design and refine the
questionnaire, we will recruit 25
participants in order to conduct 10
cognitive interviews. We estimate
cognitive interview recruitment will
take 5 minutes (0.083 hours), for a total
of 2 hours. The cognitive interviews are
estimated at 1 hour per response for a
total of 10 hours for the cognitive
interview activities. We expect to send
screeners to 800 members of a consumer
panel, each taking 2 minutes (0.03
hours) to complete, for a total of 24
hours for the consumer panel screener
activity. We also expect to administer
360 screeners to growers and retailers,
each taking 2 minutes (0.03 hours) to
complete, for a total of 22 hours (11 +
11 = 22). Twenty-four participants (20
62811
consumers, 2 growers, 2 retailers) will
complete the pretest. Each pretest will
take 10 minutes (0.17 hours) for a total
of 5 hours for the pretest activity. We
estimate that 900 individuals (540
consumers, 180 growers, and 180
retailers) will complete the
questionnaire for the experiment, each
taking 10 minutes (0.17 hours) for a total
of 153 hours for the experimental study
activities. The estimated total hour
burden of the collection of information
is 216 hours.
In the Federal Register of April 15,
2011 (76 FR 21379), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. The Agency received two
comments. The comments, and the
Agency’s responses, are discussed in the
following paragraphs.
(Comment 1) One comment suggested
that FDA should include the foodservice
distributor community in the study.
(Response) FDA disagrees. FDA is not
including the foodservice distributor
community as a study sample because
the foodservice distributor community
is responsive to retail’s demands for
product. The retail sector is included in
the study.
(Comment 2) One comment
questioned the need for FDA to apply
government resources toward the
research question, which was
characterized in the comment as a
survey of consumers’ reactions to food
recalls.
(Response) FDA disagrees that the
research data are not needed. The
proposed study utilizes an experimental
design to assess how well industry
predicts consumer reaction to a food
recall. This information will help FDA
in their risk management role during
and following a food recall. Risk
management involves communicating
both with industry and consumers about
the important health and economic
consequences related to the recall.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
mstockstill on DSK4VPTVN1PROD with NOTICES
Activity
Number of
respondents
Cognitive Interview Recruitment.
Cognitive Interviews ............
Consumer Panel Screener ..
Grower Screener .................
Retailer Screener ................
Pretests ...............................
VerDate Mar<15>2010
20:47 Oct 07, 2011
Number of
responses per
respondent
Total annual
responses
Average
burden per response
Total hours
25
25
0.08 (5 min.) ...................................................
2
10
800
360
360
24
Jkt 226001
1
1
1
1
1
1
10
800
360
360
24
1 (60 min.) ......................................................
0.03 (2 min.) ...................................................
0.03 (2 min.) ...................................................
0.03 (2 min.) ...................................................
0.17 (10 min.) .................................................
10
24
11
11
5
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\11OCN1.SGM
11OCN1
62812
Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per response
Total hours
Experiment ...................
900
1
900
0.17 (10 min.) .................................................
153
Total .............................
........................
........................
........................
........................................................................
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Olsen, S., L. MacKinnon, J.S.
Goulding, et al., ‘‘Surveillance for
Foodborne Disease Outbreaks—
United States, 1993 to 1997,’’
Morbidity and Mortality Weekly
Report, vol. 49, pp. 1–51, 2000.
2. ‘‘FDA 101: Product Recalls—From
First Alert to Effectiveness Checks,’’
(https://www.fda.gov/ForConsumers/
ConsumerUpdates/
ucm049070.htm).
3. Calvin, L., ‘‘Outbreak Linked to
Spinach Forces Reassessment of
Food Safety Practices,’’ Amber
Waves, vol. 5, pp. 24–31, 2007.
4. Lucier, G. and R. Dettmann,
‘‘Vegetables and Melons Outlook: A
Report From the United States
Department of Agriculture,
Economic Research Service,’’ VGS–
327, June 26, 2008.
Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–26131 Filed 10–7–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Appeals of Science-Based Decisions
Above the Division Level at the Center
for Veterinary Medicine—21 CFR Part
10.75 (OMB Control Number 0910–
0566)—Extension
[Docket No. FDA–2011–N–0509]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 November
10, 2011.
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0566. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
20:47 Oct 07, 2011
Jkt 226001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Respondents: Respondents to this
collection of information are applicants
that wish to submit a request for review
of a scientific dispute.
The Center for Veterinary Medicine’s
Guidance for Industry #79 ‘‘Dispute
Resolution Procedures for ScienceBased Decisions on Products Regulated
by the Center for Veterinary Medicine’’
describes the process by which the
Center for Veterinary Medicine (CVM)
formally resolves disputes relating to
scientific controversies. A scientific
controversy involves issues concerning
a specific product regulated by CVM
related to matters of technical expertise
and requires specialized education,
training, or experience to be understood
and resolved. Further, the guidance
details information on how the Agency
intends to interpret and apply
provisions of the existing regulations
regarding internal Agency review of
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants, or
manufacturers, for animal drugs or other
products regulated by CVM, that wish to
submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established Agency
channels of supervision for review.
In the Federal Register of July 13,
2011 (76 FR 41264), 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:
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62810-62812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26131]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0263]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experiment To
Evaluate Risk Perceptions of Produce Growers, Food Retailers, and
Consumers After a Food Recall Resulting From a Foodborne Illness
Outbreak
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (the PRA).
DATES: Fax written comments on the collection of information by
November 10, 2011.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Experiment to Evaluate Risk Perceptions of Produce Growers,
Food Retailers, and Consumers After a Food Recall Resulting From a
Foodborne Illness Outbreak.'' Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., 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.
Experiment To Evaluate Risk Perceptions of Produce Growers, Food
Retailers, and Consumers After a Food Recall Resulting From a Foodborne
Illness Outbreak--(OMB Control Number 0910--NEW)
I. Background
This proposed collection of information entitled ``Experiment to
Evaluate Risk Perceptions of Produce Growers, Food Retailers, and
Consumers After a Food Recall Resulting From a Foodborne Illness
Outbreak'' will be conducted under a cooperative agreement between the
Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the
Center for Risk Communication Research (CRCR) at the University of
Maryland. JIFSAN was established in 1996 and is a public and private
partnership between FDA and the University of Maryland. The CRCR will
design and administer the study.
FDA is requesting OMB approval under the PRA for the CRCR to
conduct research with produce growers, food retailers, and consumers to
gain information about these groups' risk perceptions associated with
produce that has recently been subject to a food recall resulting from
a foodborne illness outbreak. The purpose of this research is to help
FDA better understand whether the magnitude and duration of the decline
in commodity consumption following food recalls can be partly explained
by grower and retailer speculations and projections about consumers'
attitudes toward food recalls resulting from foodborne illness
outbreaks. This research will be used to assess how grower, retailer,
and consumer perceptions, attitudes, knowledge, and beliefs affect
market recovery after a hypothetical fresh spinach recall.
Epidemiologists define foodborne illness outbreaks as two or more
cases of a similar illness resulting from the ingestion of a common
food (Ref. 1). Because many foodborne illness cases are mild, most
outbreaks are never
[[Page 62811]]
recognized or brought to the attention of public health authorities.
When the outbreaks are large in scale or cause hospitalization, serious
illness, or death, public health officials will inform the public in
order to try to stop the spread of disease. A food recall can occur
when a particular food in the marketplace is found to have a known
contaminant because either people have become sickened by it or
pathogen testing has revealed contamination (Ref. 2). The purpose of a
food recall is to rid retail establishments of the product and to
inform consumers that they should discard the product if they have it
in their homes. Although the purpose of a food recall is to keep
consumers from becoming ill, food recalls can be costly to all sectors
of the food distribution chain (Ref. 3). The goal of the proposed
project is to test, by experimental study, whether the psychological
tendency called ``attribution error,'' contributes to unnecessarily
prolonging the economic effects of a food recall. ``Attribution error''
is the tendency people have of overestimating others' negative response
to situations compared to their own response. If industry
decisionmakers' measures of consumer response are biased by
``attribution error,'' industry could be contributing to its own slow
recovery after a food recall.
When a widespread foodborne illness outbreak results in a food
recall, the product can be out of the marketplace for an extended
period of time; this occurred when fresh, bagged spinach was recalled
in 2006 (Ref. 3). Tomatoes were also less available following the
Salmonella Saintpaul outbreak in 2008 (Ref. 4). Although growers and
retailers want to provide safe foods, decisions surrounding production,
wholesale, and retail sales forecasting in response to a food recall
affects how quickly the food is again available for consumption. We
hypothesize that industry's overattribution of consumers' fear of the
food after such a food recall would result in the food being kept off
of the market longer than necessary.
The CRCR plans to conduct an experiment using a Web-based
questionnaire. The center will use a convenience sample of 900
participants (180 growers, 180 retailers, 540 consumers) drawn from
industry networks (for the growers and retailers), and a Web-based
panel of U.S. households (for the consumers). Participation in the
study is voluntary.
This study will help FDA better understand the reasons for the time
between a food recall resulting from a foodborne illness outbreak and
market recovery. In order to understand the complexities of market
recovery process, the CRCR will compare understandings and reactions of
growers, retailers, and consumers to a hypothetical food recall
resulting from a hypothetical foodborne illness outbreak. To make this
comparison, individuals in each group will be assigned to one of the
following experimental conditions (consisting of vignettes in the form
of news articles on a hypothetical food recall): An ``anger'' scenario,
a ``fear'' scenario, or a ``control'' scenario. After reading the news
article, participants will complete a questionnaire assessing their
emotional response; appraisals; attribution of responsibility;
perceptions about the safety of the affected produce; intentions to
grow, sell, or buy the affected produce; perceived probability of a
repeat event; and a measure of their innate ability to effectively
respond to the information in the article.
To help design and refine the questionnaire, we will recruit 25
participants in order to conduct 10 cognitive interviews. We estimate
cognitive interview recruitment will take 5 minutes (0.083 hours), for
a total of 2 hours. The cognitive interviews are estimated at 1 hour
per response for a total of 10 hours for the cognitive interview
activities. We expect to send screeners to 800 members of a consumer
panel, each taking 2 minutes (0.03 hours) to complete, for a total of
24 hours for the consumer panel screener activity. We also expect to
administer 360 screeners to growers and retailers, each taking 2
minutes (0.03 hours) to complete, for a total of 22 hours (11 + 11 =
22). Twenty-four participants (20 consumers, 2 growers, 2 retailers)
will complete the pretest. Each pretest will take 10 minutes (0.17
hours) for a total of 5 hours for the pretest activity. We estimate
that 900 individuals (540 consumers, 180 growers, and 180 retailers)
will complete the questionnaire for the experiment, each taking 10
minutes (0.17 hours) for a total of 153 hours for the experimental
study activities. The estimated total hour burden of the collection of
information is 216 hours.
In the Federal Register of April 15, 2011 (76 FR 21379), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. The Agency received two comments. The
comments, and the Agency's responses, are discussed in the following
paragraphs.
(Comment 1) One comment suggested that FDA should include the
foodservice distributor community in the study.
(Response) FDA disagrees. FDA is not including the foodservice
distributor community as a study sample because the foodservice
distributor community is responsive to retail's demands for product.
The retail sector is included in the study.
(Comment 2) One comment questioned the need for FDA to apply
government resources toward the research question, which was
characterized in the comment as a survey of consumers' reactions to
food recalls.
(Response) FDA disagrees that the research data are not needed. The
proposed study utilizes an experimental design to assess how well
industry predicts consumer reaction to a food recall. This information
will help FDA in their risk management role during and following a food
recall. Risk management involves communicating both with industry and
consumers about the important health and economic consequences related
to the recall.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Cognitive Interview 25 1 25 0.08 (5 min.).... 2
Recruitment.
Cognitive Interviews......... 10 1 10 1 (60 min.)...... 10
Consumer Panel Screener...... 800 1 800 0.03 (2 min.).... 24
Grower Screener.............. 360 1 360 0.03 (2 min.).... 11
Retailer Screener............ 360 1 360 0.03 (2 min.).... 11
Pretests..................... 24 1 24 0.17 (10 min.)... 5
[[Page 62812]]
Experiment............... 900 1 900 0.17 (10 min.)... 153
----------------------------------------------------------------------------------
Total.................... .............. .............. .............. ................. 216
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Olsen, S., L. MacKinnon, J.S. Goulding, et al., ``Surveillance for
Foodborne Disease Outbreaks--United States, 1993 to 1997,'' Morbidity
and Mortality Weekly Report, vol. 49, pp. 1-51, 2000.
2. ``FDA 101: Product Recalls--From First Alert to Effectiveness
Checks,'' (https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm).
3. Calvin, L., ``Outbreak Linked to Spinach Forces Reassessment of Food
Safety Practices,'' Amber Waves, vol. 5, pp. 24-31, 2007.
4. Lucier, G. and R. Dettmann, ``Vegetables and Melons Outlook: A
Report From the United States Department of Agriculture, Economic
Research Service,'' VGS-327, June 26, 2008.
Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-26131 Filed 10-7-11; 8:45 am]
BILLING CODE 4160-01-P
