The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 (Outcomes Study)

Forms and Documents

Document Name	Status
0915_OMB FU2 Change Request Memo 0910-0915_10-11-2024.docx Justification for No Material/Nonsubstantive Change	2024-10-18
0915_Supporting Statement_B The Real Cost Campaign Outcomes Evaluation Study_10-2024.docx Supporting Statement B	2024-10-18
0915_Supporting Statement_A The Real Cost Campaign Outcomes Evaluation Study_10-2024.docx Supporting Statement A	2024-10-18
OMB Change Request Memo 0910-0915.docx Justification for No Material/Nonsubstantive Change	2024-02-01
Attachment 22. ExPECTT 3_ Website Mock-Up FU_V2.docx Supplementary Document	2024-01-25
Attachment 17. Social Media_Comment_Responses ExPECTT 3_Baseline.docx Supplementary Document	2022-12-27
Attachment 12. 9X12_Business Reply Envelope.pdf Supplementary Document	2022-12-27

IC Document Collections

IC ID	Document Title	Status
264672	Recruitment Study Materials--Main: Follow-up waves for Longitudinal respondents Other-ENGLISH Postcards	Modified
257764	Youth Survey--Supplemental: Baseline & Follow-up Waves Other-ENGLISH Youth Survey ExPECTT 3 Baseline	Modified
257763	Youth Assent--Supplemental: Baseline & Follow-up waves Other-Social Media Study ExPECTT 3 Youth Assent	Modified
257761	Youth Screener--Supplemental Other-Social Media_Screener ExPECTT3 Baseline	Unchanged
257760	Youth Survey--Main: Baseline & Follow-ups Other-ENGLISH Youth Survey	Modified
257759	Youth Assent--Main: Baseline & Follow-up waves Other-ENGLISH Youth Assent 11 to 13	Modified
257757	Parent Permission--Main: Baseline & Follow-up waves Other-ENGLISH Parent Guardian Permission ExPECTT 3 Baseline	Modified
257639	Household Roster--Main: Baseline & Follow-up Replenishments Other-ENGLISH Parent Guardian Mail Screener	Modified
257638	Parent Screener--Main: Baseline & Follow-up Replenishments Other-ENGLISH Parent Guardian Online Screener ExPECTT 3	Modified
257637	Recruitment Study Materials--Main: Baseline Recruitment & Follow-up Replenishments Other-ENGLISH Postcards	Modified

ICR Details

OMB Control No: 0910-0915	ICR Reference No: 202410-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202312-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 (Outcomes Study)
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: 10/18/2024

	Requested	Previously Approved
Expiration Date	06/30/2026	06/30/2026
Responses	1,131,408	856,316
Time Burden (Hours)	154,921	115,399
Cost Burden (Dollars)	0	0

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Abstract: This proposed information collection supports the U.S. Food and Drug Administration’s (FDA) efforts to assess campaign effectiveness. The Center for Tobacco Products (CTP) is proposing to conduct a quantitative study of the effects of FDA’s The Real Cost campaign on youth in the U.S. The purpose of FDA’s The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 is to evaluate whether changes in key outcomes can be attributed to campaign exposure. We intend to measure self-reported campaign exposure to media advertising, which among many things, will enable FDA to assess its relationship with market-level delivery. The study will be conducted using web-based surveys that are self-administered on personal computers or web enabled mobile devices.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 1 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:
	87 FR 44409	07/26/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 7983	02/07/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Household Roster--Main: Baseline & Follow-up Replenishments
Parent Permission--Main: Baseline & Follow-up waves
Parent Screener--Main: Baseline & Follow-up Replenishments
Recruitment Study Materials--Main: Baseline Recruitment & Follow-up Replenishments
Recruitment Study Materials--Main: Follow-up waves for Longitudinal respondents
Youth Assent--Main: Baseline & Follow-up waves
Youth Assent--Supplemental: Baseline & Follow-up waves
Youth Screener--Supplemental
Youth Survey--Main: Baseline & Follow-ups
Youth Survey--Supplemental: Baseline & Follow-up Waves

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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	1,131,408	856,316	0	0	275,092	0
Annual Time Burden (Hours)	154,921	115,399	0	0	39,522	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: We are submitting this change request to update baseline study documents for use in follow-up waves of data collection.

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Annual Cost to Federal Government: $2,280,544

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)? Yes

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: 10/18/2024

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