Experimental Study; Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers

Forms and Documents

Document Name	Status
Selenium_Health_Claims_and_Disclaimers_Study_Supporting_Statement_B revised.doc Supporting Statement B	2012-12-18
Selenium Study Appendix A.doc Supplementary Document	2012-09-19
Experimental_Study_on_Selenium_Health_Claims_and_Disclaimers_Supporting_Statement_A revised.doc Supporting Statement A	2012-12-18

IC Document Collections

IC ID	Document Title	Status
204177	Survey Other-Survey Instrument	New
204176	Survey Invitation Other-Survey Invitation	New
204175	Pretest Other-Pretest	New
204174	Pretest Invitation Other-Pretest Invitation	New
204173	Cognitive Intervew Other-Survey Instrument	New
204172	Cognitive Interview Screener Other-Survey Screening Insturment	New

ICR Details

OMB Control No: 0910-0725	ICR Reference No: 201209-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study; Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/20/2012
	Date Received in OIRA: 09/21/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	18 Months From Approved
Responses	48,319	0	0
Time Burden (Hours)	1,789	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The need for this collection of information derives from the Food and Drug Administration's (FDA's) regulation of the labeling of food products under the Federal Food, Drug, and Cosmetic Act, as amended by the Nutrition Labeling and Education Act of 1990 (NLEA). NLEA regulations establish general requirements for voluntary health claims, i.e., statements in food labeling that characterize the relationship between a food substance and a disease or health-related condition (21 CFR 101.14(a)(1)). Under the petition process for new health claims (21 CFR 101.70), petitioners must submit scientific evidence supporting a proposed health claim to FDA for review. If FDA determines that there is significant scientific agreement (SSA) among experts that the proposed health claim is supported by the totality of publicly available evidence, FDA issues a regulation authorizing the claim (21 CFR 101.14(c)-(d)). Prior research has not investigated how consumers interpret labeling claims using phrases such as "certain cancers" and "anticarcinogenic effects," or whether qualifiers, such as a listing of site-specific cancers, would eliminate potential deception. The agency therefore proposes an experimental study to examine consumer reactions to health claims using those phrases, with and without various disclaimers. The objective of this proposed study is to collect quantitative data to examine consumer interpretations of two dietary supplement labeling claims, "selenium may reduce the risk of certain cancers" and "selenium may produce anticarcinogenic effects in the body," with and without various disclaimers.

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Authorizing Statute(s): None

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:
	77 FR 4329	01/27/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 57092	09/17/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Cognitive Interview Screener
Cognitive Intervew
Pretest Invitation
Pretest
Survey Invitation
Survey

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ICR Summary of Burden

	Total Approved	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	48,319	0	0	48,319	0	0
Annual Time Burden (Hours)	1,789	0	0	1,789	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 for data study.

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Annual Cost to Federal Government: $200,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 09/21/2012

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