Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States

ICR 201911-0910-016

OMB: 0910-0881

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-12-06
Supporting Statement B
2019-12-06
ICR Details
0910-0881 201911-0910-016
Active
HHS/FDA CFSAN
Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/06/2020
Retrieve Notice of Action (NOA) 12/06/2019
Any changes as a result of the pretest will need to be submitted and approved prior to fielding the main survey.
  Inventory as of this Action Requested Previously Approved
01/31/2021 36 Months From Approved
2,967 0 0
428 0 0
0 0 0

This ICR is for a one-time data collection that is part of a broader research study. The broader research study includes these consumer surveys, OMB-approved consumer focus group studies, and cosmetics industry and local regulator interviews (of which there will be 9 or less interviews.) The overall objective of the study is to collect information from consumers to better understand the impact of allergens on cosmetic users. Study participants will be asked to answer questions via a Web-based survey regarding their use of cosmetic products, whether they have experienced an adverse event caused by allergens in their cosmetics, and actions, if any, taken to avoid the allergens. FDA will use the study results to help inform consideration for possible modifications to FDA’s policy on cosmetic product safety.

None
None

Not associated with rulemaking

  83 FR 55896 11/08/2018
84 FR 64322 11/21/2019
Yes

4
IC Title Form No. Form Name
Pretest Invitation
Pretest
Survey Invitation
Survey

  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 2,967 0 0 2,967 0 0
Annual Time Burden (Hours) 428 0 0 428 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$440,263
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  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.
12/06/2019


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