E9-12669. 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 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 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 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

Portion of Study	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per 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.

Dated: May 26, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

Footnotes

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.  http://www.cfsan.fda.gov/​~dms/​cfsup196.html.