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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA 44 U.S.C. 35013521, 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. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A 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 FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs 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,
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when appropriate, and other forms of information technology.
Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim Healthy on Packaged Foods OMB Control Number 0910NEW
Section 403r1A of the Federal Food, Drug, and Cosmetic Act FD&C
Act 21 U.S.C. 343r1A permits the use of label and labeling claims that characterize the level of a nutrient in a food when the claims are made in accordance with FDAs regulations.
Such claims are referred to as nutrient content claims. We have issued regulations under section 403r1A of the FD&C Act defining implied nutrient content claims as those that imply that a food, because of its nutrient content, may be useful in achieving a total diet that conforms to current dietary recommendations Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms, 58 FR 2302 at 2374, January 6, 1993. We have determined that a claim that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices is clearly a claim that characterizes the level of nutrients in that food. The claim is essentially saying that the level of nutrients in the food is such that the food will contribute to good health 58
FR 2302 at 2375. In 1994, we issued a definition of healthy as an implied nutrient content claim 59 FR 24232, May 10, 1994; the regulation is codified at 21 CFR 101.65d2.
In 2018, we announced our Nutrition Innovation Strategy https
www.fda.gov/food/food-labelingnutrition/fda-nutrition-innovationstrategy outlining key priorities the Agency intended to pursue to reduce the burden of chronic disease through improved nutrition and advance its public health mission. To help advance these goals, we are exploring the development of a graphic symbol to help consumers identify packaged food products that meet FDAs definition of healthy. The symbol would be a graphic representation of the nutrient content claim healthy and, like the implied nutrient content claim healthy itself, would be voluntary for packaged food companies. Companies could voluntarily use the symbol on food products that meet FDAs definition of healthy.
In 2019 and 2020, FDA conducted a review of the literature on front-ofpackage FOP nutrition-related symbols and conducted a series of focus groups to test symbol concepts and draft FOP
symbols see Docket No. FDA2021N

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0336 for a table of draft FOP symbols and the literature review.
As part of its efforts to promote public health, FDA proposes to conduct three consecutive quantitative research studiesan experimental study and two surveysto explore consumer responses to the draft FOP symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim healthy. If research results suggest the need, the symbols will be fine-tuned following the experimental study and again fine-tuned following each survey. The first study will be a controlled, randomized experiment hereafter called Study 1. Study 1 will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel maintained by a contractor. The surveys, Studies 2 and 3, will each utilize the same instrument, a 10-minute questionnaire, to test sets of draft FOP symbols. Studies 2 and 3 will each draw a sample of 1,000 U.S. adult participants from an online consumer panel.
Conditions for Study 1 will be: 1 A
set of draft FOP symbols, including nosymbol controls; 2 three types of mock food products i.e., a breakfast cereal, a frozen meal, and a canned soup; 3 a no-information condition where no explanation of the symbol is provided; and; 4 a Uniform Resource Locator URL condition, in which a URL is tested alongside the symbol.
Each participant in Study 1 will be randomly assigned to a condition, which will include viewing a label image and responding to various measures of the symbols effectiveness.
Product perceptions e.g., healthfulness and contribution to a healthy diet, label perceptions e.g., believability and trustworthiness, and purchase/choice questions will constitute the measures of response in the experiment. The instrument will also collect information from participants about their history of purchasing or consuming similar products; nutrition knowledge; dietary interests; motivation regarding label use;
health status; and demographic characteristics.
Studies 2 and 3 will utilize nonprobability survey methods, using a web-based panel to draw a sample of U.S. adults ages 18 and older who selfidentify as primary food shoppers. The sample will be balanced to the demographics of the U.S. population.
The survey instruments will focus on clarity, relevance, and appeal of a small subset of revised symbols.
The studies are part of our continuing effort to enable consumers to make
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