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

Forms and Documents

Document Name	Status
0910-0788 PRA SS_Part A_FU5_REVISED (clean).docx Supporting Statement A	2019-02-11
0910-0788 Summary of Changes to EFECT Instrument for FU5.docx Justification for No Material/Nonsubstantive Change	2019-02-11
0910-0788 change request memo EFECT.docx Justification for No Material/Nonsubstantive Change	2019-02-11
0910-0788 PRA SS_Part B_FU5_REVISED.docx Supporting Statement B	2019-02-11
0788 Early Bird Incentive Clarification.docx Supplementary Document	2018-04-16
Attachment 01a_Fresh_Empire_Storyboards_FU5_NEW.docx Supplementary Document	2019-02-11
Attachment 15_Interview Incentive Receipt_FU5.docx Supplementary Document	2019-02-11
Attachment 14b_Questions and Answers Fact Sheet (Web Cross Sectional)_FU5.docx Supplementary Document	2019-02-11
Attachment 14a_Questions and Answers Fact Sheet (Household Longitudinal)_FU5.docx Supplementary Document	2019-02-11
Attachment 12 _Sorry I Missed You Card_FU5.docx Supplementary Document	2019-02-11
Attachment 06_Study Description_FU5.docx Supplementary Document	2019-02-11
Attachment 4_ Incentive Lit Review.doc Supplementary Document	2018-04-16
Attachment 03a_Social_Media_Ads_FU5_NEW.docx Supplementary Document	2019-02-11

IC Document Collections

IC ID	Document Title	Status
215947	Youth Online Screener– Outcome Survey Other-Longitudinal Web Consent and Assent	Modified
215945	Cross-Sectional Youth Refresher Sample, Post-test and Assent/Consent Process - Outcome Surveys 1-5 Other-Post Campaign Instrument	Modified
215944	Longitudinal Cohort Youth Assent/Consent Process and Post-Tests 1-5 – Outcome Survey Other-Verification Call Script Age 18	Modified
215943	Youth Pre-Test – Outcome Survey Other-Post Campaign Instrument	Modified
215942	Adult Parental Permission Process – Outcome Survey Other-Outcome Parent Lead Letter (Longitudinal)	Modified
215941	Youth Mail Screener - Outcome Survey Other-Outcome Mail Screener	Removed

ICR Details

OMB Control No: 0910-0788	ICR Reference No: 201901-0910-003
Status: Historical Active	Previous ICR Reference No: 201808-0910-001
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: 03/22/2019
	Date Received in OIRA: 02/12/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	08/31/2021	08/31/2021
Responses	84,058	0	107,743
Time Burden (Hours)	13,162	0	15,135
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:
	82 FR 61003	12/26/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 16863	04/17/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Cross-Sectional Youth Refresher Sample, Post-test and Assent/Consent Process - Outcome Surveys 1-5
Youth Pre-Test – Outcome Survey
Longitudinal Cohort Youth Assent/Consent Process and Post-Tests 1-5 – Outcome Survey
Youth Online Screener– Outcome Survey
Adult Parental Permission Process – Outcome Survey
Youth Mail Screener - Outcome 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	84,058	107,743	0	0	-23,685	0
Annual Time Burden (Hours)	13,162	15,135	0	0	-1,973	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:

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Annual Cost to Federal Government: $8,996,243

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

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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: 02/12/2019

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