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

Forms and Documents

Document Name	Status
0910-0753 Change Request memo.docx Justification for No Material/Nonsubstantive Change	2017-04-21
1 Part A ExPECTT RuSTEC_FINAL.docx Supporting Statement A	2016-09-13
2. Part B ExPECTT RuSTEC.docx Supporting Statement B	2016-06-09
Suppl 4_E2. Rationale for Changes to ExPECTT Media Tracking.docx Supplementary Document	2016-06-09
Suppl 3_E2c. Rationale for Changes to ExPECTT Parent Instrument.docx Supplementary Document	2016-06-09
Suppl 3_E2ab. Rationale for Changes to ExPECTT Parent Screener.docx Supplementary Document	2016-06-09
Suppl 2_R. Rationale for Changes to Youth Follow-up 2 Instrument RuSTEC.docx Supplementary Document	2017-04-20
Suppl 2_E2b. Rationale for Changes to Youth Follow Up Instrument ExPECTT.docx Supplementary Document	2016-06-09
Suppl 2_E2a. Rationale for Changes to Youth Baseline Instrument ExPECTT.docx Supplementary Document	2016-06-09
Suppl 2_E1. Rationale for Changes to Youth Follow-up Instrument ExPECTT.docx Supplementary Document	2016-06-28
Attachment 9. Privacy and Data Security.doc Supplementary Document	2016-06-09
Attachment 5. Incentives.doc Supplementary Document	2016-06-09
Attachment 4. Rationale for Conducting Media Tracking.docx Supplementary Document	2016-06-09
Attachment 2a. Rationale for Outcome Evaluation Measures.doc Supplementary Document	2016-06-09
Attachment 1. FSPTCA.pdf Supplementary Document	2016-06-09

IC Document Collections

IC ID	Document Title	Status
222024	Cohort 2--Youth 1st, 2nd, 3rd Follow-Up Questionnaire Other-Youth Follow-up Instrument ExPECTT	Unchanged
222019	Cohort 2--Youth Baseline Questionnaire Other-Youth Baseline Instrument ExPECTT	Unchanged
208714	Media Tracking Questionnaires 1st, 2nd and; 3rd Other-Media Tracking Instrument ExPECTT	Unchanged
208713	Media Tracking Screener Other-Media Tracking Screener ExPECTT	Unchanged
208712	Parent Of Youth Baseline Survey Participants Other-Email Reminder 3 ExPECTT	Modified
208711	Youth 1st, 2nd, and; 3rd (Male, Rural Smokeless) follow up questionnaire Other- Incentive Letter (male rural smokeless)	Modified
208710	Youth Baseline Questionnaire (Male Rural Smokeless) Other-Youth Baseline	Modified
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 Guardian Tablet Screener ExPECTT	Modified

ICR Details

OMB Control No: 0910-0753	ICR Reference No: 201704-0910-011
Status: Historical Active	Previous ICR Reference No: 201606-0910-003
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: 04/24/2017
	Date Received in OIRA: 04/21/2017
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	122,717	0	122,717
Time Burden (Hours)	25,208	0	25,208
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
Youth 1st, 2nd, and; 3rd (Male, Rural Smokeless) follow up questionnaire
Parent Of Youth Baseline Survey Participants
Media Tracking Screener
Youth Baseline Questionnaire (Experimenter and Non-Trier)
General Population Screener and Consent Process (Youth and Parent)
Youth 1st, 2nd, 3rd Follow-Up Questionnaire (Experimenter and Non-Trier)
Youth Baseline Questionnaire (Male Rural Smokeless)
Media Tracking Questionnaires 1st, 2nd and; 3rd
Cohort 2--Youth Baseline Questionnaire
Cohort 2--Youth 1st, 2nd, 3rd Follow-Up Questionnaire

---

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	122,717	122,717	0	0	0	0
Annual Time Burden (Hours)	25,208	25,208	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

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: 04/21/2017

---