OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201209-0910-002 · OMB 0910-0725 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement B
2012-12-18
Supplementary Document
2012-09-19
Supporting Statement A
2012-12-18
IC Document Collections
IC ID
Document
Title
Status
204177 New
204176 New
204175 New
204174 New
204173 New
204172 New
ICR Details
0910-0725 201209-0910-002
Historical Active
HHS/FDA
Experimental Study; Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 12/20/2012
Retrieve Notice of Action (NOA) 09/21/2012
  Inventory as of this Action Requested Previously Approved
07/31/2014 18 Months From Approved
48,319 0 0
1,789 0 0
0 0 0
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.
None
None
Not associated with rulemaking
  77 FR 4329 01/27/2012
77 FR 57092 09/17/2012
Yes
  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
Yes
Miscellaneous Actions
No
This is a new information collection for data study.
$200,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
  No
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.
09/21/2012