View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0915
ICR Reference No:
202410-0910-004
Status:
Historical Inactive
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
OIRA Conclusion Action:
Withdrawn and continue
Conclusion Date:
02/20/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/18/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2026
06/30/2026
06/30/2026
Responses
856,316
0
856,316
Time Burden (Hours)
115,399
0
115,399
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
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
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.
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
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:
10/18/2024
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