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

ICR 201710-0910-015

OMB: 0910-0851

Federal Form Document

Forms and Documents
Document
Name
Status
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 New
228808 New
228807 New
228781 New
228780 New
228779 New
228778 New
ICR Details
0910-0851 201710-0910-015
Historical Active
HHS/FDA CTP
Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 04/24/2018
Retrieve Notice of Action (NOA) 10/31/2017
Approved consistent with the understanding that HHS/FDA will clarify the applicability of its privacy responsibilities, described in OMB circular A-130 and 5 USC §552a(e)(3), to this information collection.  FDA/CTP will document the reasons it has determined that a Privacy Act system records notice, Privacy Act statement, and privacy impact assessment are or are not required, and submit such documentation as deemed necessary to OMB as a change request within 6 months of the date of approval for the current ICR.
  Inventory as of this Action Requested Previously Approved
04/30/2021 36 Months From Approved
25,811 0 0
6,258 0 0
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 0 0 25,811 0 0
Annual Time Burden (Hours) 6,258 0 0 6,258 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
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.
10/31/2017
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