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

Forms and Documents

Document	Type	Status	Availability
0851_Point of Sale Intervention for Tobacco Evaluation PIA.pdf	Supplementary Document	Uploaded 2018-10-12	Repair queued
0851 PIA Change Request.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-10-12	Available
Stimuli Graphics.pdf	Supplementary Document	Uploaded 2018-04-23	Available
FDA POS Markets 15 Control 15 Treatment 2.13.2018 MAP and CHART.PPTX	Supplementary Document	Uploaded 2018-04-23	Repair queued
0. POSITEv SS Part A.docx	Supporting Statement A	Uploaded 2017-10-27	Available
IRB Letter.pdf	Supplementary Document	Uploaded 2017-10-27	Repair queued
0. POSITEv SS Part B.doc	Supporting Statement B	Uploaded 2017-10-27	Repair queued
Attachment_12_Privacy_and_Data_Security Clean.doc	Supplementary Document	Uploaded 2018-04-23	Repair queued
Attachment_11_Justification_of_Incentives.doc	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_10_Field_Interviewer_Confidentiality_Agreement.doc	Supplementary Document	Uploaded 2017-10-27	Available
Attachment_9d_Invitation_Email_and_Text_for_Waves_2_3_4.docx	Supplementary Document	Uploaded 2017-10-27	Available
Attachment_9c_Panel_Maintenance_Letter.docx	Supplementary Document	Uploaded 2017-10-27	Available
Attachment_9b_Appointment_Card_for_Waves_2_3_4.pptx	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_9a_lead_letter_waves_2_3_4.docx	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_8_Incentive_Receipt.docx	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_7_Study_Questions_and_Answers.docx	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_6b_Notifications.doc	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_6a_Sorry_I_Missed_You_Card.docx	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_5d_Letter_for_incentive_check_waves_2_3_4.docx	Supplementary Document	Uploaded 2017-10-27	Repair queued
Attachment_05c_reminder_letter_for_mail_screener Clean.docx	Supplementary Document	Uploaded 2018-04-23	Repair queued
Attachment_5b_Thank_You_Reminder_Postcard.docx	Supplementary Document	Uploaded 2017-10-27	Available
Attachment_05a_cover_letter_for_mail_screener Clean.docx	Supplementary Document	Uploaded 2018-04-23	Repair queued
Attachment_04d_app-based_notifications_and_messages clean.docx	Supplementary Document	Uploaded 2018-04-23	Repair queued
Attachment_04c_Rationale_for_App-based_data_collection Clean.docx	Supplementary Document	Uploaded 2018-04-23	Available
Attachment_04b_POSITEv_App_download_instructions Clean.docx	Supplementary Document	Uploaded 2018-04-23	Repair queued
Attachment_2c_Rationale_for_Outcome_Evaluation_Measures.docx	Supplementary Document	Uploaded 2017-10-27	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
228809	Study Participants (opt in)	Other-App-based Data Collection Consent Script	Unchanged
228808	Adult smokers ages 25 to 54; Telephone Verification, Questionnaires 1 - 4	Other-Telephone Verification Survey	Unchanged
228807	Adult smokers ages 25 to 54; Wave 2 - 4 Questionnaires	Other-Wave 2, 3, 4 Conset Form	Unchanged
228781	Adult smokers ages 25 to 54; Wave 1 Questionnaire	Other-Wave 1 Evaluation Consent	Unchanged
228780	Households (adults 18 and up); Telephone Verification, Field Screener	Other-Telephone Verification Survey	Unchanged
228779	Households (adults 18 and up); Field Screener	Other-Field Screener	Unchanged
228778	Households (adults 18 and up); Mail screener	Other-Mail Screener	Unchanged

ICR Details

OMB Control No: 0910-0851	ICR Reference No: 201810-0910-002
Status: Historical Active	Previous ICR Reference No: 201710-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/16/2018
	Date Received in OIRA: 10/12/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	04/30/2021	04/30/2021
Responses	25,811	0	25,811
Time Burden (Hours)	6,258	0	6,258
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 80075	11/15/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 49834	10/27/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Adult smokers ages 25 to 54; Wave 2 - 4 Questionnaires
Study Participants (opt in)
Households (adults 18 and up); Mail screener
Households (adults 18 and up); Field Screener
Adult smokers ages 25 to 54; Wave 1 Questionnaire
Households (adults 18 and up); Telephone Verification, Field Screener
Adult smokers ages 25 to 54; Telephone Verification, Questionnaires 1 - 4

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: New collection

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Annual Cost to Federal Government: $9,398,395

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 10/12/2018

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