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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Statement_B ExPECTT 3 clean.docx	Supporting Statement B	Uploaded 2023-05-30	Available
Supporting Statement_B ExPECTT 3 clean.docx	Supporting Statement B	Uploaded 2023-05-30	Repair queued
Supporting Statement_A ExPECTT 3 clean.docx	Supporting Statement A	Uploaded 2023-05-30	Available
Supporting Statement_A ExPECTT 3 clean.docx	Supporting Statement A	Uploaded 2023-05-30	Repair queued
Attachment 22. ExPECTT 3 redesign mockup.pdf	Supplementary Document	Uploaded 2022-12-27	Available
Attachment 22. ExPECTT 3 redesign mockup.pdf	Supplementary Document	Uploaded 2022-12-27	Repair queued
Attachment 17. Social Media_Comment_Responses ExPECTT 3_Baseline.docx	Supplementary Document	Uploaded 2022-12-27	Available
Attachment 17. Social Media_Comment_Responses ExPECTT 3_Baseline.docx	Supplementary Document	Uploaded 2022-12-27	Repair queued
Attachment 12. 9X12_Business Reply Envelope.pdf	Supplementary Document	Uploaded 2022-12-27	Available
Attachment 12. 9X12_Business Reply Envelope.pdf	Supplementary Document	Uploaded 2022-12-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257764	Youth Survey--Supplemental: Baseline & Follow-up 1,2,3	Other-ENGLISH Youth Survey ExPECTT 3 Baseline	Modified
257763	Youth Assent--Supplemental: Baseline & Follow-up 1,2,3	Other-Social Media Study ExPECTT 3 Youth Assent	Unchanged
257761	Youth Screener--Supplemental	Other-Social Media_Screener ExPECTT3 Baseline	Unchanged
257760	Youth Survey--Main: Baseline & Follow-up 1,2,3	Other-ENGLISH Youth Survey ExPECTT 3 Baseline	Modified
257759	Youth Assent--Main: Baseline & Follow-up 1,2,3	Other-ENGLISH Youth Assent 11 to 13 ExPECTT 3 Baseline	Unchanged
257757	Parent Permission--Main: Baseline & Follow-up 1,2,3	Other-ENGLISH Parent Guardian Permission ExPECTT 3 Baseline	Unchanged
257640	CATI Screener--Main: Baseline & Follow-up 2 Replenishment	Other-CATI Script ExPECTT 3 Baseline	Unchanged
257639	Household Roster--Main: Baseline & Follow-up 2 Replenishment	Other-ENGLISH Parent Guardian Mail Screener	Unchanged
257638	Parent Screener--Main: Baseline & Follow-up 2 Replenishment	Other-ENGLISH Parent Guardian Online Screener ExPECTT 3	Unchanged
257637	Parent Recruitment Study Materials--Main: Baseline & Follow-up 2 Replenishment	Other-ENGLISH Postcards ExPECTT 3 Baseline	Modified

ICR Details

OMB Control No: 0910-0915	ICR Reference No: 202305-0910-001
Status: Historical Active	Previous ICR Reference No: 202212-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 (Outcomes Study)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/15/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/31/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	36 Months From Approved
Responses	903,656	0	0
Time Burden (Hours)	132,274	0	0
Cost Burden (Dollars)	0	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:
	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

---

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

table that charts list of burden

IC Title	Form No.	Form Name
CATI Screener--Main: Baseline & Follow-up 2 Replenishment
Household Roster--Main: Baseline & Follow-up 2 Replenishment
Parent Permission--Main: Baseline & Follow-up 1,2,3
Parent Recruitment Study Materials--Main: Baseline & Follow-up 2 Replenishment
Parent Screener--Main: Baseline & Follow-up 2 Replenishment
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

---

ICR Summary of Burden

table that charts list 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	903,656	0	0	0	903,656	0
Annual Time Burden (Hours)	132,274	0	0	0	132,274	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: New collection

---

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.     No

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

---

Common Form ICR:  No

---

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: 05/31/2023

---