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

Forms and Documents

Document Name	Status
SS Part B Final 10.28.13_tracked changes.doc Supporting Statement B	2013-10-30
SS Part A 0910_New Evaluation of FDA Tobacco Public Education Campaign F_tracked changes.docx Supporting Statement A	2013-10-30

IC Document Collections

IC ID	Document Title	Status
208714	Media Tracking Questionnaires 1st, 2nd & 3rd Other-Survey	New
208713	Media Tracking Screener Instruction	New
208712	Parent Of Youth Baseline Survey Participants Instruction	New
208711	Youth 1st, 2nd, & 3rd (Male, Rural Smokeless) fullow up questionnaire Instruction	New
208710	Youth Baseline Questionnaire (Male Rural Smokeless) Instruction	New
208709	Youth 1st, 2nd, 3rd Follow-Up Questionnaire (Experimenter and Non-Trier) Instruction	New
208708	Youth Baseline Questionnaire (Experimenter and Non-Trier) Instruction	New
208707	General Population Screener and Consent Process (Youth and Parent) Instruction	New

ICR Details

OMB Control No: 0910-0753	ICR Reference No: 201309-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 20492
Title: Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/31/2013
	Date Received in OIRA: 09/16/2013
Terms of Clearance: In accordance with the terms of 5 CFR 1320, this ICR is approved for a period of three years. In subsequent waves of this study, we note that FDA may need to replace the stimuli as the ad campaign changes. These changes can be submitted as non-substantive changes. For all other changes, FDA should consult with OMB as early as possible.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	36 Months From Approved
Responses	70,618	0	0
Time Burden (Hours)	12,612	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The Food and Drug Administration (FDA) requests a 3-year 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:
	78 FR 37546	06/21/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 55725	09/11/2013
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
General Population Screener and Consent Process (Youth and Parent)
Youth Baseline Questionnaire (Experimenter and Non-Trier)
Youth 1st, 2nd, 3rd Follow-Up Questionnaire (Experimenter and Non-Trier)
Youth Baseline Questionnaire (Male Rural Smokeless)
Youth 1st, 2nd, & 3rd (Male, Rural Smokeless) fullow up questionnaire
Parent Of Youth Baseline Survey Participants
Media Tracking Screener
Media Tracking Questionnaires 1st, 2nd & 3rd

---

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	70,618	0	0	70,618	0	0
Annual Time Burden (Hours)	12,612	0	0	12,612	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

---

Annual Cost to Federal Government: $12,148,807

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

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: 09/16/2013

---