Proposed Collection; Comment Request; 5 A Day Customized Survey, 28544-28545 [05-9853]

Download as PDF 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Industry on Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations; Availability AGENCY: Food and Drug Administration, HHS.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entitled ‘‘Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.’’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Protection Act of 1996 (the FQPA), for food containing residues of pesticide chemicals, for which tolerances have been revoked, suspended, or modified pursuant to dietary risk considerations.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 Jkt 205001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 18MYN1

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]


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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
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