[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Notices]
[Page 12364-12365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr09-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0354]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mental Models Study
of Farmers' Understanding and Implementation of Good Agricultural
Practices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
DATES: Fax written comments on the collection of information by April
23, 2009.
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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title, ``Mental Models Study of Farmers' Understanding and
Implementation of Good Agricultural Practices.'' Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Mental Models Study of Farmers' Understanding and Implementation of
Good Agricultural Practices
The proposed information collection will help FDA protect the
public from foodborne illness by increasing the agency's understanding
of how farmers and growers use Good Agricultural Practices (GAPs) to
address common risk factors in their operations and thereby minimize
food safety hazards potentially associated with fresh produce. Fresh
fruits and vegetables are those that are likely to be sold to consumers
in an unprocessed or minimally processed (i.e., raw) form and that are
reasonably likely to be consumed raw. Under section 903(b)(2) of the
Federal Food, Drug, and Cosmetic Act (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 Title 42 of the Public Health Service
Act (1944), FDA has authority to act to protect the public health.
In 1998, FDA issued a guidance document entitled ``Guide to
Minimize
[[Page 12365]]
Microbial Food Safety Hazards for Fresh Fruits and Vegetables,''
available at http://www.cfsan.fda.gov/~dms/prodguid.html. The guidance
addresses microbial food safety hazards and good agricultural and good
management practices common to the growing, harvesting, washing,
sorting, packing, and transporting of most fruits and vegetables sold
to consumers in an unprocessed or minimally processed (raw) form.
There is evidence that growers have not fully implemented the GAPs
to reduce production risks, despite intensive GAPS training programs.
FDA is planning to conduct a study to determine growers' decision-
making processes with regard to understanding and implementing GAPs on
the farm, to more fully understand the barriers and constraints
associated with GAPs implementation.
The project will use ``mental modeling,'' a qualitative research
method wherein the decision-making processes of a group of respondents
(described below) concerning the implementation of GAPs on the farm are
modeled and compared to a model based on expert knowledge and
experience in the implementation of GAPs. The information will be
collected via a telephone interview concerning the factors that
influence the perceptions and motivations related to the implementation
of GAPs. A comparison between expert and consumer models based on the
collected information may identify ``consequential knowledge gaps''
that can be redressed through information campaigns designed by FDA.
Description of respondents:
Respondents will be farmers or growers, GAPs trainers, and retail
buyer and/or grower association representatives.
In the Federal Register of July 1, 2008 (73 FR 37464), FDA
published a 60-day notice requesting public comment on the proposed
information collection. FDA received one letter in response to the
notice, containing one or more comments. One comment recommended that
FDA increase the sample size and ensure that key subsets of the produce
industry are surveyed. FDA responds that the proposed study is
qualitative in nature. FDA does not intend the results of this study to
be a quantitative estimate of the prevalence of the use of GAPs across
the produce industry. The proposed sample size is sufficient to enable
FDA to construct mental models of the barriers and constraints related
to GAPs implementation. FDA agrees with the recommendation to ensure
key subsets of the industry are included in the study.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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Screener 80 1 80 0.02 2
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Pre-tests/ Cognitive Interviews 9 1 9 .75 6.75
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Farmers/ Growers 24 1 24 .75 18
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GAPs Trainers 24 1 24 .75 18
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Retail Buyers/ Growers 12 1 12 .75 9
Association Representatives
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Total .............. .............. .............. .............. 53.75
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In the 60-day notice published on July 1, 2008, FDA estimated the
total burden hours to be 51.75. FDA has made changes to its burden
estimate, reflected in table 1 of this document. FDA added a screener
and listed the participants separately in the table. The new total
burden hours are estimated to be 53.75 and are described in the
following paragraphs.
Approximately 80 respondents will be screened. We estimate that it
will take a respondent 1.2 minutes (0.02 hours) to complete the
screening questions, for a total of 1.6 hours (rounded to 2). FDA will
conduct 9 pretests; we estimate that it will take respondents 45
minutes (0.75 hours) to complete the pretest, for a total of 6.75
hours. Sixty respondents will complete the interview. We estimate that
it will take respondents 45 minutes (0.75 hours) to complete the entire
interview, for a total of 45 hours. Thus, the total estimated burden is
53.75 hours. FDA's burden estimate is based on prior experience with
mental models research that is similar to this proposed study.
The study will involve approximately 60 respondents, including 24
farmers or growers of fruits and vegetables, 24 GAPs trainers, and 12
retail buyer or grower association representatives. FDA estimates that
each respondent will take 45 minutes (0.75 hours) to complete the
interview for the study (60 respondents x 0.75 hours = 45 hours).
Thus, the total annual burden for this one-time collection of
information is 53.75 hours (2 hours + 6.75 hours + 45 hours = 53.75
hours). These estimates are based on FDA's experience with consumer
research.
Dated: March 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6393 Filed 3-23-09; 8:45 am]
BILLING CODE 4160-01-S