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

ICR 201512-0910-002

OMB: 0910-0753

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2015-12-03
Justification for No Material/Nonsubstantive Change
2015-07-14
Supporting Statement B
2015-07-14
Supporting Statement A
2015-12-03
IC Document Collections
IC ID
Document
Title
Status
208714 Modified
208713 Modified
208712 Modified
208711 Modified
208710 Modified
208709 Modified
208708 Modified
208707 Modified
ICR Details
0910-0753 201512-0910-002
Historical Active 201506-0910-029
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 12/14/2015
Retrieve Notice of Action (NOA) 12/04/2015
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
10/31/2016 10/31/2016 10/31/2016
70,618 0 70,618
12,612 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
  
None
Not associated with rulemaking
Yes
  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 70,618 70,618 0 0 0 0
Annual Time Burden (Hours) 12,612 12,612 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$12,148,807
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
  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.
12/04/2015
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