[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37464-37465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0354]


Agency Information Collection Activities; Proposed Collection; 
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 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 the proposed study entitled ``Mental Models 
Study of Farmers' Understanding and Implementation of Good Agricultural 
Practices.''

DATES: Submit written or electronic comments on the collection of 
information by September 2, 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

[[Page 37465]]

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.

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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Pre-tests/ Cognitive Interviews                                         9                     1                  9                .75               6.75
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Study                                                                  60                     1                 60                .75                 45
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Total                                                                                                                                              51.75
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 will also 
conduct a pretest using 9 respondents. 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 51.75 
hours (6.75 hours + 45 hours = 51.75 hours). These estimates are based 
on FDA's experience with consumer research.
    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: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14887 Filed 6-30-08; 8:45 am]
BILLING CODE 4160-01-S