FDA conducts research and educational and public information programs relating to food safety pursuant to its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (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. FDA helps consumers make informed dietary decisions by regulating nutrition information in food labeling, initiating its own consumer education activities, and collaborating with public and private entities in conveying nutrition information to consumers. These activities are aimed at influencing consumer awareness, understanding, and behaviors related to diet and nutrition and ultimately health outcomes of the Nation.
The Nutrition Labeling and Education Act (NLEA), which amended the Food, Drug and Cosmetic Act, requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements. There are three different types of claims that the food industry can voluntarily use on food labels. Although they are regulated differently, they all must be truthful and not misleading.
FDA is proposing to conduct an experimental study to quantitatively assess consumer reactions to different whole grain statements. The purpose of the study is to help enhance FDA's understanding of consumer comprehension and perceptions of food labels that use whole grains labeling statements. The study is part of the agency's continuing effort to enable consumers to make informed dietary choices and construct healthful diets. The results of the study will be used for informing possible measures that the agency may take to help consumers make such choices.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.