Information Collection Request

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

ICR 201711-0910-003 · OMB 0910-0753 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
0910-0753 OMB Change request Memo 11.1.17.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-11-02 Available
2. Part B ExPECTT RuSTEC.docx Supporting Statement B Uploaded 2017-11-02 Available
1 Part A ExPECTT RuSTEC.docx Supporting Statement A Uploaded 2017-11-02 Available
0910-0753 Change Request Memo.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-07-28 Available
0910-0753 Change Request memo.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-04-21 Available
Suppl 4_E2. Rationale for Changes to ExPECTT Media Tracking.docx Supplementary Document Uploaded 2016-06-09 Available
Suppl 3_E2c. Rationale for Changes to ExPECTT Parent Instrument.docx Supplementary Document Uploaded 2016-06-09 Available
Suppl 3_E2ab. Rationale for Changes to ExPECTT Parent Screener.docx Supplementary Document Uploaded 2016-06-09 Available
Suppl 2_R. Rationale for Changes to Youth FU3 Instrument RuSTEC.docx Supplementary Document Uploaded 2017-11-02 Available
Suppl 2_E2b. Rationale for Changes to ExPECTT Instrument.docx Supplementary Document Uploaded 2017-11-02 Available
Suppl 2_E2a. Rationale for Changes to Youth Baseline Instrument ExPECTT.docx Supplementary Document Uploaded 2016-06-09 Available
Suppl 2_E1. Rationale for Changes to Youth Follow-up Instrument ExPECTT.docx Supplementary Document Uploaded 2016-06-28 Available
Attachment 9. E2 Privacy and Data Security.docx Supplementary Document Uploaded 2017-11-02 Available
Attachment 5. Incentives.doc Supplementary Document Uploaded 2016-06-09 Available
Attachment 4. Rationale for Conducting Media Tracking.docx Supplementary Document Uploaded 2016-06-09 Repair queued
Attachment 2a. Rationale for Outcome Evaluation Measures.doc Supplementary Document Uploaded 2016-06-09 Available
Attachment 1. FSPTCA.pdf Supplementary Document Uploaded 2016-06-09 Available
IC Document Collections
IC IDCollectionTypeStatusForm
222024 Cohort 2--Youth 1st, 2nd, 3rd Follow-Up Questionnaire Other-Youth Follow-up Instrument ExPECTT Modified
222019 Cohort 2--Youth Baseline Questionnaire Other-Youth Baseline Instrument ExPECTT Modified
208714 Media Tracking Questionnaires 1st, 2nd and; 3rd Other-Media Tracking Instrument Unchanged
208713 Media Tracking Screener Other-Media Tracking Youth Assent Unchanged
208712 Parent Of Youth Baseline Survey Participants Other-Notifications (male rural smokeless) Modified
208711 Youth 1st, 2nd, and; 3rd (Male, Rural Smokeless) follow up questionnaire Other-Consent Forms 18 (male rural smokeless) Modified
208710 Youth Baseline Questionnaire (Male Rural Smokeless) Other-Youth Baseline Unchanged
208709 Youth 1st, 2nd, 3rd Follow-Up Questionnaire (Experimenter and Non-Trier) Other-Youth Assent under 18 ExPECTT Unchanged
208708 Youth Baseline Questionnaire (Experimenter and Non-Trier) Other-Youth Assent under 18 ExPECTT Unchanged
208707 General Population Screener and Consent Process (Youth and Parent) Other-Parent Permission ExPECTT FU Modified
ICR Details
0910-0753 201711-0910-003
Historical Active 201707-0910-016
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 11/16/2017
Retrieve Notice of Action (NOA) 11/03/2017
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 09/30/2019 09/30/2019
123,390 0 122,717
25,713 0 25,208
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

  81 FR 8511 02/19/2016
81 FR 39675 06/17/2016
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 123,390 122,717 0 0 673 0
Annual Time Burden (Hours) 25,713 25,208 0 0 505 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$12,637,812
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
11/03/2017