Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign

ICR 202006-0910-005

OMB: 0910-0753

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-06-16
Supplementary Document
2020-01-09
Supporting Statement B
2019-09-09
Supporting Statement A
2020-01-09
Supplementary Document
2017-11-02
Supplementary Document
2017-11-02
Supplementary Document
2016-06-09
Supplementary Document
2016-06-09
Supplementary Document
2016-06-09
ICR Details
0910-0753 202006-0910-005
Historical Active 201907-0910-024
HHS/FDA CTP
Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/19/2020
Retrieve Notice of Action (NOA) 06/17/2020
  Inventory as of this Action Requested Previously Approved
01/31/2023 01/31/2023 01/31/2023
25,707 0 25,707
7,327 0 7,327
0 0 0

The Food and Drug Administration (FDA) requests Office of Management and Budget (OMB) approval to conduct in-person and Web-based surveys of youth in targeted areas in the United States. These surveys will be fielded for purposes of evaluating FDA's general market youth tobacco prevention campaigns. The primary outcome evaluation will consist of an initial baseline survey before the launch of each of three campaigns and three longitudinal follow-up surveys of those participants in 8-month intervals following the baseline data collection. In addition, a tracking survey to assess awareness of the campaigns and receptivity to campaign messages will occur in 8-month intervals throughout the data collection period. As part of the outcome evaluation study, a baseline survey will also be conducted with the parent or legal guardian of each youth baseline survey participant in order to collect data on household characteristics and media use. Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaigns and changes in outcome variables of interest.

PL: Pub.L. 111 - 31 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  
None

Not associated with rulemaking

  84 FR 22499 05/17/2019
84 FR 46021 09/03/2019
No

  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 25,707 25,707 0 0 0 0
Annual Time Burden (Hours) 7,327 7,327 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
FDA has revised the burden due to the decision to complete data collection for the Media Tracking Survey. Therefore, the estimated burden hours for the 1) Screener and Consent Process, 2) Parent Baseline Questionnaire, 3) Media Tracking Screener, and 4) three waves of Media Tracking Questionnaires are no longer needed or requested. In addition, we have completed the baseline and first wave of follow-up data collection for Cohort 2 of the General Market campaign evaluation. The associated burden for those activities has been removed for this extension. This resulted in a decrease of 97,683 responses and 18,386 hours (from the currently approved 123,390 responses and 25,713 hours). The remaining burden to complete the final rounds of data collection is estimated to be 25,707 respondents/annual responses and 7,327 hours.

$12,641,919
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/17/2020


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