Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices, 37464-37465 [E8-14887]
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Federal Register / Vol. 73, No. 127 / Tuesday, July 1, 2008 / Notices
assesses the effectiveness of CMS’
quality reporting activities.
• Effectively communicates program
policies related to the Prescription Drug
and Medicare Advantage (MA) programs
to heath plans and drug plan
contractors, employer group sponsors,
beneficiary advocates and other
stakeholders in the health care field.
• Develops new policies (e.g. health
plan access, benefits, special needs
plans) and programs to reflect changes
in program objectives, the health care
delivery system, beneficiary health care
needs, and new plan types to support an
appropriate range of choices for
beneficiaries.
• Collaborates with our partners, such
as industry, other government entities
and advocacy groups, to understand
their perspectives on Prescription Drug
and Medicare Managed Care policies
and procedures and to drive best
practices in the health care industry.
• Develops and implements a
comprehensive strategic plan, objectives
and measures for overseeing an effective
compliance and oversight program for
all Part C (Medicare Advantage) and
Part D (Medicare Prescription Drug)
contractors in close collaboration with
CMHPO, the Medicare Drug Benefit and
C & D Data Group, the Medicare Drug
and Health Plan Contract
Administration Group and other Center
for Drug and Health Plan Choice
components.
• Develops and implements a
comprehensive and effective audit
program for all Part C (Medicare
Advantage) and Part D (Medicare
Prescription Drug) contractors.
Dated: June 21, 2008.
James W. Weber,
Acting Director, Office of Operations
Management, Centers for Medicare &
Medicaid Services.
[FR Doc. E8–14896 Filed 6–30–08; 8:45 am]
sroberts on PROD1PC70 with NOTICES
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2008–N–0354]
[Docket No. FDA–2004–N–0188] (formerly
Docket No. 2004N–0081)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Request for Designation as Country
Not Subject to the Restrictions
Applicable to Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing, Material From Cattle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Request for Designation as Country not
Subject to the Restrictions Applicable to
Human Food and Cosmetics
Manufactured from, Processed With, or
Otherwise Containing, Material from
Cattle’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
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.
In the
Federal Register of April 17, 2008 (73
FR 20785), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0623. The
approval expires on June 30, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14882 Filed 6–30–08; 8:45 am]
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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.
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 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:
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
E:\FR\FM\01JYN1.SGM
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37465
Federal Register / Vol. 73, No. 127 / Tuesday, July 1, 2008 / Notices
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
https://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 BURDEN1
21 CFR Section
No. of
Respondents
Pre-tests/ Cognitive Interviews
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
9
9
.75
6.75
60
Study
1
1
60
.75
45
Total
sroberts on PROD1PC70 with NOTICES
1There
51.75
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
VerDate Aug<31>2005
21:01 Jun 30, 2008
Jkt 214001
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
https://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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0146]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements for
Collection of Data Relating to the
Prevention of Medical Gas Mix-ups at
Health Care Facilities-Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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]]>Agencies
[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37464-37465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14887]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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: 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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-tests/ Cognitive Interviews 9 1 9 .75 6.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 60 1 60 .75 45
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 51.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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
