Agency Information Collection Activities; Submission for OMB Review; Comment Request; Consumer Surveys on Food and Dietary Supplement Labeling Issues

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

DATES:

Submit written comments on the collection of information by January 22, 2003.

ADDRESSES:

Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Consumer Surveys on Food and Dietary Supplement Labeling Issues—(OMB Control Number 0910-0492)—Extension

FDA is requesting an extension of the OMB approval of consumer surveys to help FDA's Center for Food Safety and Applied Nutrition formulate decisions and policies affecting the labeling of conventional foods and dietary supplements. Determining how consumers are likely to interpret various kinds of claims, disclaimers, warnings, caution statements, and notice statements that might appear in labeling is critical to agency decisionmaking under the Federal Food, Drug, and Cosmetic Act and the first amendment. It is often necessary to test actual or proposed labeling statements in realistic situations with typical consumers to determine what these label statements are communicating to consumers.

FDA or its contractor will collect and use information gathered from telephone, mail, shopping mall intercept, or Internet surveys to evaluate how consumers understand and respond to existing label statements, label statements proposed by industry or consumers, and other label statements that are under consideration as part of FDA's policy development process. Potential respondents to the surveys will be individual consumers either randomly chosen to represent specified populations or randomly assigned to experimental treatment conditions to control for the effects of individual differences in the population on the interpretation of label statements. In all instances, FDA will strive to collect a representative sample of individuals from the overall population or from relevant population groups as appropriate. FDA's general selection method will use stratification, with random sampling within the strata, to achieve representativeness for both overall populations and sensitive subpopulations, such as at-risk individuals or user segments. In the rare cases where geography is a limiting factor, FDA will use population-based cluster sampling to limit Government expense while preserving the statistical properties of the sample.

Respondents will provide background information and respond to package labels that contain the variations of label statements to be tested. Measures will include both self-reported comprehension and acceptance, as well as direct behavioral measures of consumer use and understanding of the package labeling.

FDA will use the information from the surveys in evaluating regulatory and policy options with respect to labeling. The agency often lacks empirical data about how consumers understand and respond to statements they might see in product labeling. The information gathered from such surveys can be used to test consumer comprehension and behavioral impact of various label statements and formats, taking into account the existing distribution of behavior, knowledge, and attitudes in the population that provides the context for understanding such statements. The surveys will help FDA assess consumer reactions to existing and proposed label statements.

FDA estimates the burden of this collection of information as follows:

These estimates assume that as many as one mail survey project, one telephone survey project, and two Internet or mall intercept survey projects may be done on an annual basis. Estimates are based on the expected number of respondents necessary to obtain a statistically significant representation of important consumer segments (e.g., users of relevant regulated products or at-risk population groups) and the number of labeling options that may need to be tested.