Proposed Collection; Comment Request; 5 A Day Customized Survey, 28544-28545 [05-9853]
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28544
Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Notices
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 0910–0359. The
approval expires on April 30, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: May 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9810 Filed 5–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0263] (formerly Docket
No. 03D–0263)
Guidance for Industry on Channels of
Trade Policy for Commodities With
Residues of Pesticide Chemicals, for
Which Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Channels of Trade Policy for
Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have
Been Revoked, Suspended, or Modified
by the Environmental Protection Agency
Pursuant to Dietary Risk
Considerations.’’ This guidance presents
FDA’s general policy for implementing
the channels of trade provision in the
Federal Food, Drug, and Cosmetic Act
(the act), as amended by the Food
Quality Protection Act of 1996 (the
FQPA), for food containing residues of
pesticide chemicals, for which
tolerances have been revoked,
suspended, or modified pursuant to
dietary risk considerations.
DATES: You may submit written or
electronic comments on agency
guidances at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to Michael
E. Kashtock, Office of Plant and Dairy
Foods, Center for Food Safety and
Applied Nutrition (HFS–305), Food and
Drug Administration, 5100 Paint Branch
VerDate jul<14>2003
14:03 May 17, 2005
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Pkwy., College Park, MD 20740. Include
a self-addressed adhesive label to assist
that office in processing your request.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS–
305), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2022, e-mail:
mkashtoc@cfsan.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 23,
2003 (68 FR 43535), FDA announced the
availability of a draft guidance
document entitled ‘‘Guidance for
Industry: Channels of Trade Policy for
Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have
Been Revoked, Suspended, or Modified
by the Environmental Protection
Agency.’’ This guidance presents FDA’s
general policy for implementing the
channels of trade provision in the act,
as amended by the FQPA. Interested
persons were given until September 22,
2003, to comment on the draft guidance.
FDA received five written comments
on the draft guidance document. The
agency reviewed and evaluated these
comments and has modified the
guidance where appropriate. In
particular, FDA has modified the
guidance document, including its title,
to make it clear that it applies solely to
food commodities that contain residues
of pesticide chemicals for which the
applicable tolerance was revoked,
suspended, or modified by the
Environmental Protection Agency (EPA)
pursuant to dietary risk considerations
as addressed under section 408(l)(2) of
the FQPA. A comment pointed out that
this condition was implied in the draft
guidance document, but that it should
be explicit in the final guidance.
FDA is issuing this guidance as a level
1 guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The guidance represents the
agency’s current thinking on its planned
enforcement approach to the channels
of trade provision of the act and how
that provision relates to FDA-regulated
products with residues of pesticide
chemicals for which tolerances have
been revoked, suspended, or modified
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by EPA pursuant to dietary risk
considerations. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if it satisfies the requirements of
the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
this guidance was approved under OMB
Control No. 0910–0562. The approval
expires on May 31, 2008. 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.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Interested persons also may access the
guidance document at https://
www.cfsan.fda.gov/guidance.html.
Dated: March 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9811 Filed 5–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; 5 A Day Customized Survey
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
E:\FR\FM\18MYN1.SGM
18MYN1
28545
Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Notices
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: 5 A Day Customized Survey.
Type of Information Collection
Request: NEW.
Need and Use of Information
Collection: The purpose of the 5 A Day
Customized Survey is to further the
development of standardized measures
of consumer knowledge, attitudes, and
behaviors regarding the consumption of
fruits and vegetables. Specifically, the
Survey will allow for validation of the
new ‘‘cup’’ portion sizes (consistent
with the 2005 Dietary Guidelines) and
identify the most efficacious short
screener methods of fruit and vegetable
intake. In addition, the 5 A Day
Customized Survey will measure
established predictors of the fruit and
vegetable consumption at the national
level and explore new predictors and
constructs not previously examined for
fruit and vegetable consumption. The
sample will be drawn from a consumer
opinion panel methodology using
balancing techniques to mirror the U.S.
general population on a set of key
demographic variables. A separate
sample of African Americans will be
drawn from the panel. Prior to fielding
the Customized Survey, a pilot study
will be conducted with a 200
individuals to assess validity of the two
fruit and vegetable screeners (which are
embedded in the Customized Survey).
In the pilot study, respondents will
initially complete three 24-hour dietary
recalls over the phone and receive the
5 A Day Customized Survey by mail as
a follow-up.
Fruit and vegetable consumption as
assessed by the average of the three 24hour recalls will be compared with fruit
and vegetable consumption as assessed
separately by the two fruit and vegetable
screener methods from the Customized
Survey. In addition, the psychometric
properties of the remaining items from
the Customized Survey will be
evaluated. Based on the pilot study
findings, minor modifications may be
made to the Customized Survey, and a
final instrument will be submitted to
OMB for review prior to the main
implementation of the Customized
Survey.
Frequency of response: One-time for
the main implementation. For the pilot,
subjects will complete three 24-hour
dietary recalls over the phone and also
complete a mailed copy of the 5 A Day
Customized Survey.
Affected public: Individuals.
Type of Respondents: U.S. adults,
Pilot Survey, 5 A Day Customized
Survey. The annual reporting burden is
presented in exhibit 1 below. There are
no Operating or Maintenance Costs to
report.
EXHIBIT 1
Estimates of respondent hour burden
Number of
respondents
Frequency of
response
Average
burden hours
per response
Annual hour
burden
Pilot Study ........................................................................................................
5 A Day Customized Survey main implementation .........................................
200
4,000
4
1
0.50
0.50
400
2,000
Total ..........................................................................................................
4,200
........................
........................
2,400
Request for comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the
proposed performance of the functions
of the agency, including whether the
information shall have practical utility;
(2) The accuracy of the 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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Amy Lazarus
Yaroch, Ph.D, Project Officer, National
Cancer Institute, NIH, EPN 4074, 6130
Executive Boulevard MSC 7335,
Bethesda, Maryland 20892–7335, or call
VerDate jul<14>2003
14:03 May 17, 2005
Jkt 205001
non-toll-free number 301–402–8425, or
FAX your request to 301–480–2087, or
E-mail your request, including your
address, to yarocha@mail.nih.gov.
Comments due date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: May 10, 2005.
Rachelle Ragland-Greene,
National Institutes of Health, NCI Project
Clearance Liaison.
[FR Doc. 05–9853 Filed 5–17–05; 8:45 am]
BILLING CODE 4101–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
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Fmt 4703
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The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group. Subcommittee
I—Career Development.
Date: June 14–15, 2005.
Time: 8 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham City Center Hotel, 1143
New Hampshire Ave., NW., Washington, DC
20037.
Contact Person: Robert Bird, PhD,
Scientific Review Administrator, Resources
and Training Review Branch, National
Cancer Institute, National Institutes of
Health, 6116 Executive Blvd., MSC 8328,
Room 8113, Bethesda, MD 20892–8328. (301)
496–7978, birdr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
E:\FR\FM\18MYN1.SGM
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Agencies
[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Notices]
[Pages 28544-28545]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; 5 A Day Customized Survey
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity
for public comment on proposed data collection projects, the National
Cancer Institute (NCI), National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of
[[Page 28545]]
Management and Budget (OMB) for review and approval.
Proposed Collection
Title: 5 A Day Customized Survey.
Type of Information Collection Request: NEW.
Need and Use of Information Collection: The purpose of the 5 A Day
Customized Survey is to further the development of standardized
measures of consumer knowledge, attitudes, and behaviors regarding the
consumption of fruits and vegetables. Specifically, the Survey will
allow for validation of the new ``cup'' portion sizes (consistent with
the 2005 Dietary Guidelines) and identify the most efficacious short
screener methods of fruit and vegetable intake. In addition, the 5 A
Day Customized Survey will measure established predictors of the fruit
and vegetable consumption at the national level and explore new
predictors and constructs not previously examined for fruit and
vegetable consumption. The sample will be drawn from a consumer opinion
panel methodology using balancing techniques to mirror the U.S. general
population on a set of key demographic variables. A separate sample of
African Americans will be drawn from the panel. Prior to fielding the
Customized Survey, a pilot study will be conducted with a 200
individuals to assess validity of the two fruit and vegetable screeners
(which are embedded in the Customized Survey). In the pilot study,
respondents will initially complete three 24-hour dietary recalls over
the phone and receive the 5 A Day Customized Survey by mail as a
follow-up.
Fruit and vegetable consumption as assessed by the average of the
three 24-hour recalls will be compared with fruit and vegetable
consumption as assessed separately by the two fruit and vegetable
screener methods from the Customized Survey. In addition, the
psychometric properties of the remaining items from the Customized
Survey will be evaluated. Based on the pilot study findings, minor
modifications may be made to the Customized Survey, and a final
instrument will be submitted to OMB for review prior to the main
implementation of the Customized Survey.
Frequency of response: One-time for the main implementation. For
the pilot, subjects will complete three 24-hour dietary recalls over
the phone and also complete a mailed copy of the 5 A Day Customized
Survey.
Affected public: Individuals.
Type of Respondents: U.S. adults, Pilot Survey, 5 A Day Customized
Survey. The annual reporting burden is presented in exhibit 1 below.
There are no Operating or Maintenance Costs to report.
Exhibit 1
----------------------------------------------------------------------------------------------------------------
Estimates of respondent hour burden
---------------------------------------------------------------
Average
Number of Frequency of burden hours Annual hour
respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Pilot Study..................................... 200 4 0.50 400
5 A Day Customized Survey main implementation... 4,000 1 0.50 2,000
-----------------
Total....................................... 4,200 .............. .............. 2,400
----------------------------------------------------------------------------------------------------------------
Request for comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proposed performance of the functions of the agency,
including whether the information shall have practical utility; (2) The
accuracy of the 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 those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
For Further Information Contact: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Amy Lazarus Yaroch, Ph.D, Project Officer,
National Cancer Institute, NIH, EPN 4074, 6130 Executive Boulevard MSC
7335, Bethesda, Maryland 20892-7335, or call non-toll-free number 301-
402-8425, or FAX your request to 301-480-2087, or E-mail your request,
including your address, to yarocha@mail.nih.gov.
Comments due date: Comments regarding this information collection
are best assured of having their full effect if received within 60-days
of the date of this publication.
Dated: May 10, 2005.
Rachelle Ragland-Greene,
National Institutes of Health, NCI Project Clearance Liaison.
[FR Doc. 05-9853 Filed 5-17-05; 8:45 am]
BILLING CODE 4101-01-P