Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign

Forms and Documents

Document Name	Status
Rationale for Item Changes to the ExPECTT 2nd Follow-up Instrument.docx Supplementary Document	2020-01-09
0753_Supporting Statement_Part B_2019.docx Supporting Statement B	2019-09-09
Part A ExPECTT 0910-0753 Final.docx Supporting Statement A	2020-01-09
Suppl 2_E2b. Rationale for Changes to ExPECTT Instrument.docx Supplementary Document	2017-11-02
Attachment 9. E2 Privacy and Data Security.docx Supplementary Document	2017-11-02
Attachment 5. Incentives.doc Supplementary Document	2016-06-09
Attachment 2a. Rationale for Outcome Evaluation Measures.doc Supplementary Document	2016-06-09
Attachment 1. FSPTCA.pdf Supplementary Document	2016-06-09

IC Document Collections

IC ID	Document Title	Status
222024	Cohort 2--Youth Aged 11 to 18 Other-Routing for Consent ExPECTT	Modified
222019	Cohort 2--Youth Assent Other-Youth Assent under 18	Modified
208714	Media Tracking Questionnaires 1st, 2nd and; 3rd Other-Media Tracking Instrument	Removed
208713	Media Tracking Screener Other- Media Tracking Parent Permission	Removed
208712	Parent Of Youth Baseline Survey Participants Other-Email Reminder 3 ExPECTT	Modified
208711	Youth 1st, 2nd, 3rd and 4th (Male, Rural Smokeless) follow up questionnaire Other-Youth Followup3 Instrument (male rural smokeless)	Removed
208710	Youth Baseline Questionnaire (Male Rural Smokeless) Other-Youth Baseline	Removed
208709	Youth 1st, 2nd, 3rd and 4th Follow-Up Questionnaire (Experimenter and Non-Trier) Other-Youth Assent under 18 ExPECTT	Removed
208708	Youth Baseline Questionnaire (Experimenter and Non-Trier) Other-Youth Assent under 18 ExPECTT	Removed
208707	General Population Screener and Consent Process (Youth and Parent) Other-Parent Permission ExPECTT FU	Modified

ICR Details

OMB Control No: 0910-0753	ICR Reference No: 201907-0910-024
Status: Historical Active	Previous ICR Reference No: 201902-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/16/2020
	Date Received in OIRA: 09/12/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	25,707	0	123,390
Time Burden (Hours)	7,327	0	25,713
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) requests Office of Management and Budget (OMB) approval to conduct in-person and Web-based surveys of youth in targeted areas in the United States. These surveys will be fielded for purposes of evaluating FDA's general market youth tobacco prevention campaigns. The primary outcome evaluation will consist of an initial baseline survey before the launch of each of three campaigns and three longitudinal follow-up surveys of those participants in 8-month intervals following the baseline data collection. In addition, a tracking survey to assess awareness of the campaigns and receptivity to campaign messages will occur in 8-month intervals throughout the data collection period. As part of the outcome evaluation study, a baseline survey will also be conducted with the parent or legal guardian of each youth baseline survey participant in order to collect data on household characteristics and media use. Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaigns and changes in outcome variables of interest.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  

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:
	84 FR 22499	05/17/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 46021	09/03/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Youth 1st, 2nd, 3rd and 4th (Male, Rural Smokeless) follow up questionnaire
Youth 1st, 2nd, 3rd and 4th Follow-Up Questionnaire (Experimenter and Non-Trier)
Media Tracking Screener
Youth Baseline Questionnaire (Male Rural Smokeless)
Cohort 2--Youth Assent
Cohort 2--Youth Aged 11 to 18
Parent Of Youth Baseline Survey Participants
Media Tracking Questionnaires 1st, 2nd and; 3rd
Youth Baseline Questionnaire (Experimenter and Non-Trier)
General Population Screener and Consent Process (Youth and Parent)

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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	25,707	123,390	0	0	-97,683	0
Annual Time Burden (Hours)	7,327	25,713	0	0	-18,386	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: FDA has revised the burden due to the decision to complete data collection for the Media Tracking Survey. Therefore, the estimated burden hours for the 1) Screener and Consent Process, 2) Parent Baseline Questionnaire, 3) Media Tracking Screener, and 4) three waves of Media Tracking Questionnaires are no longer needed or requested. In addition, we have completed the baseline and first wave of follow-up data collection for Cohort 2 of the General Market campaign evaluation. The associated burden for those activities has been removed for this extension. This resulted in a decrease of 97,683 responses and 18,386 hours (from the currently approved 123,390 responses and 25,713 hours). The remaining burden to complete the final rounds of data collection is estimated to be 25,707 respondents/annual responses and 7,327 hours.

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Annual Cost to Federal Government: $12,641,919

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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: 09/12/2019

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