Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim "Healthy" on Packaged Food

Forms and Documents

Document Name	Status
NEW Supporting Statement Healthy Symbols - Part B 2022 Final.pdf Supporting Statement B	2022-04-11
NEW Supporting Statement Healthy Symbols - Part A 2022 Final.pdf Supporting Statement A	2022-04-11

IC Document Collections

IC ID	Document Title	Status
252826	Study 2: "Healthy" Symbols Experiment Other-Screener guide	New
252819	Study 1: "Healthy" Symbols Survey Other-Screener guide	New

ICR Details

OMB Control No:	ICR Reference No: 202204-0910-011
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim "Healthy" on Packaged Food
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/12/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	7,000	0
Time Burden (Hours)	1,671	0
Cost Burden (Dollars)	0	0

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Abstract: This ICR is for a one-time data collection consisting of a web-administered sample survey and an experimental study whose overall objective is to test consumer reaction to several design options for a symbol that manufacturers can voluntarily use on food products that meet the FDA definition of a healthy food per serving. To assess they symbols’ effectiveness, the survey instruments will focus on clarity, relevance, appeal, and likelihood of use of a small subset of symbols. Sample study and experimental study participants will be randomly assigned to view one of three mock food products labels (breakfast cereal, frozen meal, canned soup) containing a single symbol (including a no-symbol control) and asked to respond to questions on perceptions about the food. The research is part of the Agency’s continuing effort to provide consumers with information to assist them in making informed dietary choices and constructing healthful diets. The Agency will use this research for the continued exploration of a symbol for “Healthy” that is effective for communicating with consumers that, per serving, the food with the symbol is a healthy choice.

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Authorizing Statute(s): US Code: 21 USC 343(r)(1)(A) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 24629	05/07/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 17300	03/28/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Study 1: "Healthy" Symbols Survey
Study 2: "Healthy" Symbols Experiment

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	7,000	0	0	7,000	0	0
Annual Time Burden (Hours)	1,671	0	0	1,671	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $300,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/12/2022

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