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

Forms and Documents

Document Name	Status
Attachment 24b. Reminder Letter_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 24. Reminder Letter ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 23b. Email_reminder4 _Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 23. Email_reminder4 ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 22b. Reminder Letter_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 22. Reminder Letter ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 21b. Email_reminder3 _Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 21. Email_reminder3 ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 20b. Email_reminder2 _Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 20. Email_reminder2 ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 19b. Email_reminder1_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 19. Email_reminder1_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 18b. Survey Invitation Email_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 18. Survey Invitation Email ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 15b. Panel Maintenance Letter_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 15. Panel Maintenance Letter ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 13. Notifications ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 11b. Q&As_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 11. Q&As about ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 10b. Lead Letter_Young Adult_ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 10. Lead Letter ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 06d. Youth Consent 18 and up ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 06c. Youth Assent under 18 ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 06b. Parent Guardian Permission ExPECTT II 5th FU.docx Supplementary Document	2022-04-07
Attachment 2. ExPECTT II Youth Instrument_5th FU_3_17_2022.docx Supplementary Document	2022-04-07
OMB Change Request Roadmap - 0910-0753 Follow-up 5.docx Supplementary Document	2022-04-07
Change Request Memo_MAR 2022.docx Justification for No Material/Nonsubstantive Change	2022-04-07
Document Roadmap September 2020.docx Supplementary Document	2020-09-22
Change Request Memo Sept 2020.docx Justification for No Material/Nonsubstantive Change	2020-09-22
Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2020-06-16
Rationale for Item Changes to the ExPECTT 2nd Follow-up Instrument.docx Supplementary Document	2020-01-09
2. Part B ExPECTT_FU5_3-4-22.docx Supporting Statement B	2022-04-07
1. Part A ExPECTT_FU5_3-4-22.docx Supporting Statement A	2022-04-07
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	Unchanged
222019	Cohort 2--Youth Assent Other-Youth Assent under 18	Unchanged
208712	Parent Of Youth Baseline Survey Participants Other-Email Reminder 3 ExPECTT	Unchanged
208707	General Population Screener and Consent Process (Youth and Parent) Other-Parent Permission ExPECTT FU	Unchanged

ICR Details

OMB Control No: 0910-0753	ICR Reference No: 202204-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202009-0910-008
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/07/2022

	Requested	Previously Approved
Expiration Date	01/31/2023	01/31/2023
Responses	27,401	27,401
Time Burden (Hours)	8,894	8,894
Cost Burden (Dollars)	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
Cohort 2--Youth Aged 11 to 18
Cohort 2--Youth Assent
General Population Screener and Consent Process (Youth and Parent)
Parent Of Youth Baseline Survey Participants

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ICR Summary of Burden

	Total Request	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	27,401	27,401	0	0	0	0
Annual Time Burden (Hours)	8,894	8,894	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: FDA has added burden for the fourth follow up. This resulted in an increase of 1,694 responses and 1,567 hours. The new estimated burden for this collection is 8,894 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? No

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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: 04/07/2022

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