Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign

ICR 201810-0910-002

OMB: 0910-0851

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2018-10-12
Justification for No Material/Nonsubstantive Change
2018-10-12
Supplementary Document
2018-04-23
Supplementary Document
2018-04-23
Supporting Statement A
2017-10-27
Supplementary Document
2017-10-27
Supporting Statement B
2017-10-27
Supplementary Document
2018-04-23
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2017-10-27
Supplementary Document
2018-04-23
Supplementary Document
2017-10-27
Supplementary Document
2018-04-23
Supplementary Document
2018-04-23
Supplementary Document
2018-04-23
Supplementary Document
2018-04-23
Supplementary Document
2017-10-27
IC Document Collections
IC ID
Document
Title
Status
228809 Unchanged
228808 Unchanged
228807 Unchanged
228781 Unchanged
228780 Unchanged
228779 Unchanged
228778 Unchanged
ICR Details
0910-0851 201810-0910-002
Historical Active 201710-0910-015
HHS/FDA CTP
Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/16/2018
Retrieve Notice of Action (NOA) 10/12/2018
  Inventory as of this Action Requested Previously Approved
04/30/2021 04/30/2021 04/30/2021
25,811 0 25,811
6,258 0 6,258
0 0 0
The Food and Drug Administration (FDA) requests a 3-year Office of Management and Budget (OMB) approval to conduct mail, in-person, online, and smartphone app-based questionnaires of adults in targeted areas of the United States. These questionnaires will be fielded for purposes of evaluating the FDA’s point-of-sale (store-based) campaign. After screening by mail and in person, the primary outcome evaluation will consist of four longitudinal in-person and online questionnaires over 24 months (approximately every 7 months). In addition, a smartphone-based app will collect passive exposure to the campaign using geolocation technology. The app will also include a brief questionnaire that assesses campaign exposure, intentions to use tobacco, and tobacco-related attitudes and beliefs 3 times over 18 months (approximately every 6 months). Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaign and the outcome variables of interest among current smokers between the ages of 25 and 54.
None
None
Not associated with rulemaking
  81 FR 80075 11/15/2016
82 FR 49834 10/27/2017
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 25,811 25,811 0 0 0 0
Annual Time Burden (Hours) 6,258 6,258 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
New collection
$9,398,395
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
10/12/2018
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