Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Symbols on Food Packages, 26244-26246 [E9-12669]

Download as PDF 26244 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices Estimated number of responses per respondent Estimated number of respondents Type of respondents Average burden hours per response Estimated total annual burden hours requested Public Sector Groups ....................................................................................... Health Professionals ........................................................................................ 332 711 0.33 0.33 0.2 0.2 22 47 Totals ........................................................................................................ 2,450 ........................ ........................ 162 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 proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Ann M. Taubenheim, Principal Investigator, National Heart, Lung, and Blood Institute, Office of Communications and Legislative Activities, NIH, 31 Center Drive, Building 31, Room 4A10, Bethesda, MD 21045, or call non-tollfree number 301–496–4236 or e-mail your request, including your address, to taubenha@nhlbi.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: May 22, 2009. Ann M. Taubenheim, Principal Investigator, NHLBI, National Institutes of Health. [FR Doc. E9–12604 Filed 5–29–09; 8:45 am] BILLING CODE 4140–10–P VerDate Nov<24>2008 15:29 May 29, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0220] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Symbols on Food Packages 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 Experimental Study of Nutrition Symbols on Food Packages. DATES: Submit written or electronic comments on the collection of information by July 31, 2009. 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 Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 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. Experimental Study of Nutrition Symbols on Food Packages FDA has been following the emergence of front-of-package nutrition symbols in the marketplace. These symbols are associated with programs from sources including food manufacturers, retailers, and third party organizations (e.g., trade and health organizations). The symbols are intended to assist consumer choice by providing simplified and easilyaccessible information on the nutritional attributes of a food product. Relevant and nonproprietary information about the effects of nutrition symbols on consumers, however, is limited (see, for example, Feunekes et al., 2008; ‘‘FDA Comments on Symbols Public Hearing and Current Plans for Addressing Issues,’’ Docket E:\FR\FM\01JNN1.SGM 01JNN1 26245 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices No. FDA–2007–N–0198).1 2 Therefore, FDA is proposing to conduct an experimental study to assess quantitative consumer reactions to front-of-package nutrition symbols. FDA conducts research and educational and public information programs relating to food safety under its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393 (b)(2)), to protect the public health by ensuring that foods are ‘‘safe, wholesome, sanitary, and properly labeled,’’ and in section 903(d)(2)(C) (21 U.S.C. 393 (d)(2)(C)), to conduct research relating to foods, drugs, cosmetics and devices in carrying out the act. The purpose of the study is to help enhance FDA’s understanding of consumer understanding and use of a selected sample of nutrition symbols in the domestic marketplace. The study is part of the agency’s continuing effort to enable consumers to make informed dietary choices and construct healthful diets. The proposed experimental study will use a Web-based survey to collect information from a sample of adult members in an online consumer panel established by a contractor. The study plans to randomly assign each of 2,400 participants to view a label from a set of food labels that vary in the presence and type of symbol, the type of food product, and the quality of nutritional attributes of the product. The study plans to make the mandatory Nutrition Facts label available to all participants. The study will focus on the following types of consumer reaction: (1) Judgments about a food product in terms of its nutritional attributes, overall healthfulness, health benefits, and other characteristics such as taste; (2) judgments about a label in terms of its credibility in conveying the product’s nutritional attributes and helpfulness in product choices; (3) identification of the more nutritious product in a pair of products; and (4) impact of the symbol on the use of the Nutrition Facts label. To help understand consumer reactions, the study will also collect information on participants’ background, including but not limited to consumption and perceptions of food products, nutrition attitudes and practice, food label use, health literacy, and health status. In addition, the study will conduct a separate face-to-face eye-tracking examination using a separate sample of 30 adult consumers to explore their label viewing patterns when they are asked to judge product attributes and to compare products. Participants will be selected from a commercial database of consumers. The study results will be used to help the agency in its continuing evaluation of issues related to the use of nutrition symbols in food labeling. The results of the experimental study will not be used to develop population estimates. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Portion of Study Cognitive interview screener Annual Frequency per Response Total Annual Responses Hours per Response 144 1 144 0.083 12 18 1 18 1 18 1,600 1 1,600 0.033 53 200 1 200 0.25 50 19,200 1 19,200 0.033 634 2,400 1 2,400 0.25 600 240 1 240 0.083 20 30 1 30 1 30 Cognitive interview Pretest invitation Pretest Survey invitation Survey Eye-tracking screener Eye-tracking Total 1 There Total Hours 1,417 are no capital costs or operating and maintenance costs associated with this collection of information.. To help design and refine the questionnaire to be used for the experimental study, we plan to conduct cognitive interviews by screening 144 adult consumers in order to obtain 18 participants in the interviews. Each screening is expected to take 5 minutes (0.083 hours) and each cognitive interview is expected to take 1 hour. The total for cognitive interview activities is 30 hours (12 hours + 18 hours). Subsequently, we plan to conduct pretests of the survey questionnaire before it is administered in the study. We expect that 1,600 invitations, each taking 2 minutes (0.033 hours), will need to be sent to adult members of an online consumer panel to have 200 of them complete a 15– minute (0.025 hours) pretest. The total for the pretest activities is 103 hours (53 hours + 50 hours). For the survey, we estimate that 19,200 invitations, each taking 2 minutes (0.033 hours), will need to be sent to adult members of an online consumer panel to have 2,400 of them complete a 15–minute (0.025 hours) questionnaire. The total for the survey activities is 1,234 hours (634 hours + 600 hours). To conduct the eye- 1 Feunekes, G. I. J., I. A. Gortemaker, A. A. Willems, and R. Lion, Front-of-pack Nutrition Labeling: Testing Effectiveness of Different Nutrition Labeling Formats Front-of-pack in Four European Countries, Appetite 50(1): 57-70, 2008. VerDate Nov<24>2008 15:29 May 29, 2009 Jkt 217001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 tracking study, we expect to screen 240 adult consumers, each taking 5 minutes (0.083 hours), to have 30 of them participate in an 1-hour interview. The total for the eye-tracking activities is 50 hours (20 hours + 30 hours). Thus, the total estimated burden is 1,417 hours. FDA’s burden estimate is based on prior experience with research that is similar to this proposed study. 2 https://www.cfsan.fda.gov/~dms/cfsup196.html. E:\FR\FM\01JNN1.SGM 01JNN1 26246 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices Dated: May 26, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–12669 Filed 5–29–09; 8:45 am] BILLING CODE 4160–01–S in the United States and Territories (OMB Control No. 0920–0743, Exp. 7/ 31/2009)–Revision–National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–09–0743] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–6974. Written comments should be received within 30 days of this notice. Proposed Project Assessment and Monitoring of Breastfeeding-Related Maternity Care Practices in Intra-partum Care Facilities Substantial evidence demonstrates the health benefits of breastfeeding. Breastfeeding mothers have lower risks of breast and ovarian cancers and type 2 diabetes, and breastfeeding better protects infants against infections, chronic diseases like diabetes and obesity, and even childhood leukemia and sudden infant death syndrome (SIDS). However, the groups that are at higher risk for diabetes, obesity, and poor health overall persistently have the lowest breastfeeding rates. Public health priorities for the U.S. include increasing the overall rate of breastfeeding, and reducing variation in breastfeeding rates across population subgroups. The health care system is one of the most important and effective settings to improve breastfeeding. In 2007, CDC conducted the first national survey of Maternity Practices in Infant Nutrition and Care (known as the mPINC Survey) in health care facilities (hospitals and free-standing childbirth centers). The survey was designed to provide baseline information and to be repeated again in 2009. It inquired about patient education and support for breastfeeding throughout the maternity stay as well as staff training and maternity care policies. Each responding organization received a customized Benchmark Report as well as other feedback to use in self-assessment and quality improvement activities. CDC proposes to repeat the mPINC in 2009 using previously fielded questions and methodology. In addition to all facilities that participated in 2007, the 2009 survey will include those that were invited but did not participate in 2007 and any that are new since then. All birth centers and hospitals with ≥ 1 registered maternity beds will be screened via a brief phone call to assess their eligibility, identify additional locations, and identify the appropriate point of contact. A major goal of the 2009 survey is to be fully responsive to respondents’ needs for information and technical assistance. CDC will again provide customized benchmark reports to respondents and document progress since 2007 on their quality improvement efforts. National and state reports will use de-identified data to describe incremental changes in practices and care processes over time at the facility, state, and national levels. Participation in the survey is voluntary, and responses may be submitted by mail or through a webbased system. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,686. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Form name Hospitals ................................. Telephone Screening Interview for Hospitals ........................ 2009 mPINC Survey for Hospitals ......................................... Telephone Screening Interview for Birth Centers .................. 2009 mPINC Survey for Birth Centers ................................... Birth Centers ........................... Number of respondents Dated: May 26, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–12631 Filed 5–29–09; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P [60Day-0920–09BS] Centers for Disease Control and Prevention Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and VerDate Nov<24>2008 15:29 May 29, 2009 Jkt 217001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 3,897 2,568 192 122 Number of responses per respondent 1 1 1 1 Average burden per response (in hours) 5/60 30/60 5/60 30/60 Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Pages 26244-26246]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0220]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Nutrition Symbols on Food 
Packages

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 Experimental Study of Nutrition Symbols 
on Food Packages.

DATES: Submit written or electronic comments on the collection of 
information by July 31, 2009.

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 Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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 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.

Experimental Study of Nutrition Symbols on Food Packages

    FDA has been following the emergence of front-of-package nutrition 
symbols in the marketplace. These symbols are associated with programs 
from sources including food manufacturers, retailers, and third party 
organizations (e.g., trade and health organizations). The symbols are 
intended to assist consumer choice by providing simplified and easily-
accessible information on the nutritional attributes of a food product. 
Relevant and nonproprietary information about the effects of nutrition 
symbols on consumers, however, is limited (see, for example, Feunekes 
et al., 2008; ``FDA Comments on Symbols Public Hearing and Current 
Plans for Addressing Issues,'' Docket

[[Page 26245]]

No. FDA-2007-N-0198).\1\ \2\ Therefore, FDA is proposing to conduct an 
experimental study to assess quantitative consumer reactions to front-
of-package nutrition symbols.
---------------------------------------------------------------------------

    \1\ Feunekes, G. I. J., I. A. Gortemaker, A. A. Willems, and R. 
Lion, Front-of-pack Nutrition Labeling: Testing Effectiveness of 
Different Nutrition Labeling Formats Front-of-pack in Four European 
Countries, Appetite 50(1): 57-70, 2008.
    \2\ https://www.cfsan.fda.gov/~dms/cfsup196.html.
---------------------------------------------------------------------------

    FDA conducts research and educational and public information 
programs relating to food safety under its broad statutory authority, 
set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 393 (b)(2)), to protect the public health by 
ensuring that foods are ``safe, wholesome, sanitary, and properly 
labeled,'' and in section 903(d)(2)(C) (21 U.S.C. 393 (d)(2)(C)), to 
conduct research relating to foods, drugs, cosmetics and devices in 
carrying out the act.
    The purpose of the study is to help enhance FDA's understanding of 
consumer understanding and use of a selected sample of nutrition 
symbols in the domestic marketplace. The study is part of the agency's 
continuing effort to enable consumers to make informed dietary choices 
and construct healthful diets.
    The proposed experimental study will use a Web-based survey to 
collect information from a sample of adult members in an online 
consumer panel established by a contractor. The study plans to randomly 
assign each of 2,400 participants to view a label from a set of food 
labels that vary in the presence and type of symbol, the type of food 
product, and the quality of nutritional attributes of the product. The 
study plans to make the mandatory Nutrition Facts label available to 
all participants. The study will focus on the following types of 
consumer reaction: (1) Judgments about a food product in terms of its 
nutritional attributes, overall healthfulness, health benefits, and 
other characteristics such as taste; (2) judgments about a label in 
terms of its credibility in conveying the product's nutritional 
attributes and helpfulness in product choices; (3) identification of 
the more nutritious product in a pair of products; and (4) impact of 
the symbol on the use of the Nutrition Facts label. To help understand 
consumer reactions, the study will also collect information on 
participants' background, including but not limited to consumption and 
perceptions of food products, nutrition attitudes and practice, food 
label use, health literacy, and health status.
    In addition, the study will conduct a separate face-to-face eye-
tracking examination using a separate sample of 30 adult consumers to 
explore their label viewing patterns when they are asked to judge 
product attributes and to compare products. Participants will be 
selected from a commercial database of consumers.
    The study results will be used to help the agency in its continuing 
evaluation of issues related to the use of nutrition symbols in food 
labeling. The results of the experimental study will not be used to 
develop population estimates.
    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
                   Portion of Study                        Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener                                          144                     1                144              0.083                 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview                                                    18                     1                 18                  1                 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest invitation                                                  1,600                     1              1,600              0.033                 53
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest                                                               200                     1                200               0.25                 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey invitation                                                  19,200                     1             19,200              0.033                634
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey                                                              2,400                     1              2,400               0.25                600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Eye-tracking screener                                                 240                     1                240              0.083                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Eye-tracking                                                           30                     1                 30                  1                 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                              1,417
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information..

    To help design and refine the questionnaire to be used for the 
experimental study, we plan to conduct cognitive interviews by 
screening 144 adult consumers in order to obtain 18 participants in the 
interviews. Each screening is expected to take 5 minutes (0.083 hours) 
and each cognitive interview is expected to take 1 hour. The total for 
cognitive interview activities is 30 hours (12 hours + 18 hours). 
Subsequently, we plan to conduct pretests of the survey questionnaire 
before it is administered in the study. We expect that 1,600 
invitations, each taking 2 minutes (0.033 hours), will need to be sent 
to adult members of an online consumer panel to have 200 of them 
complete a 15-minute (0.025 hours) pretest. The total for the pretest 
activities is 103 hours (53 hours + 50 hours). For the survey, we 
estimate that 19,200 invitations, each taking 2 minutes (0.033 hours), 
will need to be sent to adult members of an online consumer panel to 
have 2,400 of them complete a 15-minute (0.025 hours) questionnaire. 
The total for the survey activities is 1,234 hours (634 hours + 600 
hours). To conduct the eye-tracking study, we expect to screen 240 
adult consumers, each taking 5 minutes (0.083 hours), to have 30 of 
them participate in an 1-hour interview. The total for the eye-tracking 
activities is 50 hours (20 hours + 30 hours). Thus, the total estimated 
burden is 1,417 hours. FDA's burden estimate is based on prior 
experience with research that is similar to this proposed study.


[[Page 26246]]


    Dated: May 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12669 Filed 5-29-09; 8:45 am]
BILLING CODE 4160-01-S
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