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:
0910-0753
ICR Reference No:
201807-0910-011
Status:
Historical Active
Previous ICR Reference No:
201711-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
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:
Approved without change
Conclusion Date:
08/01/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/27/2018
Terms of Clearance:
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
Expiration Date
09/30/2019
09/30/2019
09/30/2019
Responses
123,390
0
123,390
Time Burden (Hours)
25,713
0
25,713
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
PL:
Pub.L. 111 - 31 31
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:
81 FR 8511
02/19/2016
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 39675
06/17/2016
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
10
IC Title
Form No.
Form Name
Cohort 2--Youth 1st, 2nd, 3rd Follow-Up Questionnaire
Cohort 2--Youth Baseline Questionnaire
General Population Screener and Consent Process (Youth and Parent)
Media Tracking Questionnaires 1st, 2nd and; 3rd
Media Tracking Screener
Parent Of Youth Baseline Survey Participants
Youth 1st, 2nd, 3rd and 4th (Male, Rural Smokeless) follow up questionnaire
Youth 1st, 2nd, 3rd and 4th Follow-Up Questionnaire (Experimenter and Non-Trier)
Youth Baseline Questionnaire (Experimenter and Non-Trier)
Youth Baseline Questionnaire (Male Rural Smokeless)
ICR Summary 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
123,390
123,390
0
0
0
0
Annual Time Burden (Hours)
25,713
25,713
0
0
0
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:
Annual Cost to Federal Government:
$12,637,812
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)?
No
Is this ICR related to the Pandemic Response?
Uncollected
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:
07/27/2018
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