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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	07/31/2026
Responses	609,031	856,316
Time Burden (Hours)	59,799	115,399
Cost Burden (Dollars)	0	0

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.

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

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

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

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	609,031	856,316	-247,285
Annual Time Burden (Hours)	59,799	115,399	-55,600
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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