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

Forms and Documents

Document	Type	Status	Availability
0910-0915_Supporting Statement A_2026.docx	Supporting Statement A	Uploaded 2026-06-25	Available
0910-0915_Supporting Statement B_2026.docx	Supporting Statement B	Uploaded 2026-06-25	Available
0915_Comment.pdf	Public Comments	Uploaded 2025-09-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
264672	Recruitment Study Materials--Main: Follow-up 1, 2, and 3 Longitudinal respondents	Other-ENGLISH Postcards	Removed
257764	Youth Survey--Supplemental: Baseline & Follow-up 1,2,3	Other-ENGLISH Youth Survey ExPECTT 3 Baseline	Removed
257763	Youth Assent--Supplemental: Baseline & Follow-up 1,2,3	Other-Social Media Study ExPECTT 3 Youth Assent	Removed
257761	Youth Screener--Supplemental	Other-Social Media_Screener ExPECTT3 Baseline	Removed
257760	Youth Survey--Main: Baseline & Follow-up 1,2,3	Other-ENGLISH Youth Survey	Removed
257759	Youth Assent--Main: Baseline & Follow-up 1,2,3	Other-ENGLISH Youth Assent 11 to 13	Removed
257757	Parent Permission--Main: Baseline & Follow-up 1,2,3	Other-ENGLISH Parent Guardian Permission ExPECTT 3 Baseline	Removed
257639	Household Roster--Main: Baseline & Follow-up 2 Replenishment	Other-ENGLISH Parent Guardian Mail Screener	Removed
257638	Parent Screener--Main: Baseline & Follow-up 2 Replenishment	Other-ENGLISH Parent Guardian Online Screener ExPECTT 3	Removed
257637	The Real Cost Campaign Outcomes Evaluation Study: Cohort 3	Other-ENGLISH Postcards	Modified

ICR Details

OMB Control No: 0910-0915	ICR Reference No: 202506-0910-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/26/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2026
Responses	609,031	856,316
Time Burden (Hours)	59,799	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:
	90 FR 31229	07/14/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 27062	05/13/2026
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Household Roster--Main: Baseline & Follow-up 2 Replenishment
Parent Permission--Main: Baseline & Follow-up 1,2,3
Parent Screener--Main: Baseline & Follow-up 2 Replenishment
Recruitment Study Materials--Main: Follow-up 1, 2, and 3 Longitudinal respondents
The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
Youth Assent--Main: Baseline & Follow-up 1,2,3
Youth Assent--Supplemental: Baseline & Follow-up 1,2,3
Youth Screener--Supplemental
Youth Survey--Main: Baseline & Follow-up 1,2,3
Youth Survey--Supplemental: Baseline & Follow-up 1,2,3

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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	609,031	856,316	0	0	-247,285	0
Annual Time Burden (Hours)	59,799	115,399	0	0	-55,600	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: To align with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, we are revising this information collection to remove questions relating to gender. For the extension, we are proposing up to 2 additional follow-up waves of data collections, including up to 2 additional replenishment samples. Additional waves are needed for this study to evaluate the influence of future “The Real Cost” public education messages on tobacco-related knowledge, attitudes, and behaviors (e.g., preventing youth from using e-cigarettes). Replenishing the sample will ensure we maintain an adequate longitudinal sample at each study wave and continue to have representation from younger respondents in our aging sample. In addition, we updated the estimated burden per response based on past data collections for the baseline and first follow-up wave. Our estimated burden for the information collection reflects an overall decrease of 55,600 hours and an increase of 247,285 responses.

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Annual Cost to Federal Government: $2,110,158

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: 06/26/2026

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