Previous terms continue: Observations and outcomes collected from the respondents participating in the campaign evaluation collections will not be generalized to the broader populations of smokers and/or nonsmokers not participating in the collections affiliated with this OMB control number. Data collected will only be used to directly inform the tobacco prevention campaign objectives and goals.
Inventory as of this Action
Requested
Previously Approved
09/30/2019
36 Months From Approved
10/31/2016
122,717
0
70,618
25,208
0
12,612
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
FDA requests approval to: 1) conduct a fourth follow-up survey with youth who are part of the first longitudinal cohort, and who participated in the baseline through third follow-up surveys; 2) develop and survey a second longitudinal cohort which will consist of an entirely new sample of youth, ages 11-16 at baseline; 3) extend the media tracking component of the evaluation, and; 4) extend the time period of the rural male smokeless component of the outcome evaluation.
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.
1 Part A ExPECTT RuSTEC_FINAL.docx
Attachment 9. Privacy and Data Security.doc
Attachment 1. FSPTCA.pdf
Cohort 2--Youth 1st, 2nd, 3rd Follow-Up Questionnaire