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. Â 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 FDAâs 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.
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.
Stimuli Graphics.pdf
FDA POS Markets 15 Control 15 Treatment 2.13.2018 MAP and CHART.PPTX
0. POSITEv SS Part A.docx
0. POSITEv SS Part B.doc
Study Participants (opt in)