OMB control number

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

OMB 0910-0851 · HHS/FDA.

OMB 0910-0851

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.

The latest form for Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign expires 2021-04-30 and is listed under ICR 201902-0910-011.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Attachment15_TelephoneTalkingPoints.docx Supplementary Document
Attachment14_WebSurveyReminderPostcards.docx Supplementary Document
OMB Change Request Memo.docx Justification for No Material/Nonsubstantive Change
0910-0851 Change Request Memo Waves_2_3_4.docx Justification for No Material/Nonsubstantive Change
Attachment_02d_Rationale for Item Changes to Questionnaire Waves 2_3_4.docx Supplementary Document
Attachment_02f_ETC Try and Try Again Storyboard.pdf Supplementary Document
Attachment_04e_Wave_2_3_4_POSITEv_App_download_instructions.docx Supplementary Document
0851_Point of Sale Intervention for Tobacco Evaluation PIA.pdf Supplementary Document
0851 PIA Change Request.docx Justification for No Material/Nonsubstantive Change
Attachment_02e_Print_Ad_Sample_Text.docx Supplementary Document
FDA POS Markets 15 Control 15 Treatment 2.13.2018 MAP and CHART.PPTX Supplementary Document
0. POSITEv SS Part A.docxSupporting Statement A
IRB Letter.pdf Supplementary Document
0. POSITEv SS Part B.docSupporting Statement B
Attachment_12_Privacy_and_Data_Security Clean.doc Supplementary Document
Attachment_11_Justification_of_Incentives.doc Supplementary Document
Attachment_10_Field_Interviewer_Confidentiality_Agreement.doc Supplementary Document
Attachment_09d_Invitation_Email_and_Text_for_Waves_2_3_4.docx Supplementary Document
Attachment_9c_Panel_Maintenance_Letter.docx Supplementary Document
Attachment_9b_Appointment_Card_for_Waves_2_3_4.pptx Supplementary Document
Attachment_9a_lead_letter_waves_2_3_4.docx Supplementary Document
Attachment_8_Incentive_Receipt.docx Supplementary Document
Attachment_07_POSITEv_Study_Questions_and_Answers_W2 clean.docx Supplementary Document
Attachment_06b_Notifications_W2 Clean.docx Supplementary Document
Attachment_06a_Sorry_I_Missed_You_Card.docx Supplementary Document
Attachment_5d_Letter_for_incentive_check_waves_2_3_4.docx Supplementary Document
Attachment_05c_reminder_letter_for_mail_screener Clean.docx Supplementary Document
Attachment_5b_Thank_You_Reminder_Postcard.docx Supplementary Document
Attachment_05a_cover_letter_for_mail_screener Clean.docx Supplementary Document
Attachment_04d_app-based_notifications_and_messages.docx Supplementary Document
Attachment_04c_Rationale_for_App-based_data_collection Clean.docx Supplementary Document
Attachment_04b_POSITEv_App_download_instructions Clean.docx Supplementary Document
Attachment_2c_Rationale_for_Outcome_Evaluation_Measures.docx Supplementary Document
Study Participants (opt in) Other-App-based Data Collection Consent Script
Adult smokers ages 25 to 54; Telephone Verification, Questionnaires 1 - 4 Other-Telephone Verification Survey
Adult smokers ages 25 to 54; Wave 2 - 4 Questionnaires Other-Wave 2, 3, 4 Consent Form
Adult smokers ages 25 to 54; Wave 1 Questionnaire Other-Wave 1 Evaluation Consent
Households (adults 18 and up); Telephone Verification, Field Screener Other-Telephone Verification Survey
Households (adults 18 and up); Field Screener Other-Field Screener
Households (adults 18 and up); Mail screener Other-Mail Screener

All Historical Document Collections

OMB Details

Households (adults 18 and up); Mail screener

Federal Enterprise Architecture: Health - Consumer Health and Safety