Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign.

Forms and Documents

Document Name	Status
Attachment 15_Interview Incentive Receipt.docx Supplementary Document	2016-03-22
Attachment 14b_Questions and Answers Fact Sheet.docx Supplementary Document	2016-03-22
Attachment 14a_Questions and Answers Fact Sheet.docx Supplementary Document	2016-03-22
Attachment 12 _Sorry I Missed You Card .docx Supplementary Document	2016-03-22
Attachment 9_ Reminder Postcard.docx Supplementary Document	2016-03-22
Attachment 6_Study Description.docx Supplementary Document	2016-03-22
Attachment 7_Non Disclosure Agreement.pdf Supplementary Document	2016-03-22
Attachment 4_ Incentive Lit Review.doc Supplementary Document	2016-03-22
Attachment 3a_Social_Media_Ad.docx Supplementary Document	2016-03-22
Change Request memo for FDA EFECT First Follow-up 0910-0788.docx Justification for No Material/Nonsubstantive Change	2016-03-22
0910-0788 SS OMB_Part B.docx Supporting Statement B	2016-03-19
0910-0788 SS OMB_Part A.docx Supporting Statement A	2016-03-19

IC Document Collections

IC ID	Document Title	Status
216679	Cross-Sectional Cohort Second post-test evaluation survey Other-Verification Call Script	Removed
216678	Cross-Sectional Cohort Second post-test evaluation survey Other-Incentive Lit Review	Removed
216677	Cross-Sectional Cohort First post-test evaluation survey Other-Incentive Lit Review	Removed
216676	Longitudinal Cohort Third post-test evaluation survey Other-Incentive Lit Review	Removed
216675	Longitudinal Cohort Second post-test evaluation survey Other-Incentive Lit Review	Removed
216672	Adults 18 and older in the United States - Screener and Consent Process- third post-test outcome survey Other-Informed consent and Assent	Removed
216669	Adults 18 and older in the United States - Screener and Consent Process- second post-test outcome survey Other-Informed consent and Assent	Removed
216668	Youth aged 12 to 17 in the United States - Screener and Consent Process- Third post-test outcome survey Other-Outcome Web Screener	Removed
216667	Youth aged 12 to 17 in the United States - Screener and Consent Process- second post-test outcome survey Other-Outcome Web Screener	Removed
215952	Multicultural youth aged 13-17 in the select media markets recruiting through social media and online panels - Post-test online survey Other-Reminder Postcard	Removed
215951	Multicultural youth aged 13-17 in the select media markets recruiting through social media and online panels - Post-test online screener Other-outcome parent lead Letter wave 2	Removed
215950	Youth Post-Test Online Outcome Survey Other-ost Campaign Instrument	Modified
215948	Youth Pre-Test Online Outcome Survey Other-Welcome to the Study Letter	Modified
215947	Youth Screener and Consent for Online Outcome Survey Other-Longitudinal Web Consent and Assent	Modified
215945	Cross-Sectional Cohort Youth Post-Test Outcome Survey Other-Post Campaign Instrument	Modified
215944	Longitudinal Cohort Youth Post-Test Outcome Survey Other-Post Campaign Instrument.	Modified
215943	Youth Pre-Test Outcome Survey Other-Post Campaign Instrument	Modified
215942	Adult Mail Screener and Consent Process for Outcome Survey Other-Outcome Mail Screener	Modified
215941	Youth Mail Screener and Consent Process for Outcome Survey Other-Outcome Mail Screener	Modified

ICR Details

OMB Control No: 0910-0788	ICR Reference No: 201603-0910-010
Status: Historical Active	Previous ICR Reference No: 201504-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural 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: 03/25/2016
	Date Received in OIRA: 03/24/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	05/31/2018	05/31/2018
Responses	106,648	0	106,648
Time Burden (Hours)	13,678	0	13,678
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) requests Office of Management and Budget (OMB) approval to conduct in-person and Web-based surveys of multicultural youth in the United States, as the Evaluation of the Fresh Empire Campaign on Tobacco (EFECT). These surveys will be fielded for purposes of evaluating FDA’s Fresh Empire public education campaign for multicultural youth 12 to 17 years old. The primary outcome evaluation will consist of a pre-test survey and cross-sectional post-test surveys with an embedded longitudinal cohort in campaign and control cities beginning approximately 6 months following the campaign launch. Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaign and changes in outcome variables of interest.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 1003(d)(2)(D) Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 230	01/05/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 19673	04/13/2015
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Longitudinal Cohort Third post-test evaluation survey
Longitudinal Cohort Second post-test evaluation survey
Multicultural youth aged 13-17 in the select media markets recruiting through social media and online panels - Post-test online survey
Youth aged 12 to 17 in the United States - Screener and Consent Process- second post-test outcome survey
Youth aged 12 to 17 in the United States - Screener and Consent Process- Third post-test outcome survey
Adults 18 and older in the United States - Screener and Consent Process- second post-test outcome survey
Cross-Sectional Cohort Youth Post-Test Outcome Survey
Youth Mail Screener and Consent Process for Outcome Survey
Youth Pre-Test Outcome Survey
Longitudinal Cohort Youth Post-Test Outcome Survey
Youth Screener and Consent for Online Outcome Survey
Youth Pre-Test Online Outcome Survey
Adults 18 and older in the United States - Screener and Consent Process- third post-test outcome survey
Adult Mail Screener and Consent Process for Outcome Survey
Youth Post-Test Online Outcome Survey
Multicultural youth aged 13-17 in the select media markets recruiting through social media and online panels - Post-test online screener
Cross-Sectional Cohort Second post-test evaluation survey
Cross-Sectional Cohort Second post-test evaluation survey
Cross-Sectional Cohort First post-test evaluation survey

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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	106,648	106,648	0	0	0	0
Annual Time Burden (Hours)	13,678	13,678	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: No burden change - ICs were restructured for organizational purposes.

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Annual Cost to Federal Government: $8,037,087

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

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Common Form ICR:  No

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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: 03/24/2016

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