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_Final.docx Supporting Statement A	2018-08-01
0910-0788 PRA SS_Part B_FU4.docx Supporting Statement B	2018-08-01
0910-0788 Summary of Changes to EFECT Instrument for FU4.docx Supplementary Document	2018-04-16
0788 Early Bird Incentive Clarification.docx Supplementary Document	2018-04-16
Attachment 14c_Questions and Answers Fact Sheet (Household Cross-Sectional)_NEW.docx Supplementary Document	2018-04-16
Attachment 01_Post Campaign Instrument_FU4.docx Supplementary Document	2018-04-19
Attachment 15_Interview Incentive Receipt_FU4.docx Supplementary Document	2018-04-16
Attachment 14b_Questions and Answers Fact Sheet (Web Cross Sectional)_FU4.docx Supplementary Document	2018-04-16
Attachment 14a_Questions and Answers Fact Sheet (Household Longitudinal)_FU4.docx Supplementary Document	2018-04-16
Attachment 12 _Sorry I Missed You Card_FU4.docx Supplementary Document	2018-04-16
Attachment 09_ Reminder Postcard_FU4.docx Supplementary Document	2018-04-16
Attachment 06_Study Description_FU4.docx Supplementary Document	2018-04-16
Attachment 4_ Incentive Lit Review.doc Supplementary Document	2018-04-16
Attachment 03a_Social_Media_Ads.docx Supplementary Document	2018-04-16

IC Document Collections

IC ID	Document Title	Status
215947	Youth Online Screener– Outcome Survey Other-Longitudinal Web Consent and Assent	Unchanged
215945	Cross-Sectional Youth Refresher Sample, Post-test and Assent/Consent Process - Outcome Surveys 1-5 Other-Post Campaign Instrument	Unchanged
215944	Longitudinal Cohort Youth Assent/Consent Process and Post-Tests 1-5 – Outcome Survey Other-Post Campaign Instrument.	Unchanged
215943	Youth Pre-Test – Outcome Survey Other-Post Campaign Instrument	Unchanged
215942	Adult Parental Permission Process – Outcome Survey Other-Informed Consent and Assent	Unchanged
215941	Youth Mail Screener - Outcome Survey Other-Outcome Mail Screener	Modified

ICR Details

OMB Control No: 0910-0788	ICR Reference No: 201808-0910-001
Status: Historical Active	Previous ICR Reference No: 201803-0910-004
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/03/2018
	Date Received in OIRA: 08/02/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved
Responses	107,743	0	0
Time Burden (Hours)	15,135	0	0
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: 6

IC Title	Form No.	Form Name
Cross-Sectional Youth Refresher Sample, Post-test and Assent/Consent Process - Outcome Surveys 1-5
Youth Mail Screener - Outcome Survey
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

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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	107,743	0	0	0	32,638	75,105
Annual Time Burden (Hours)	15,135	0	0	0	4,813	10,322
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: FDA requests OMB approval to extend the evaluation of FDA’s multicultural youth tobacco public education campaign and to add two additional waves of data collection. Continued evaluation is necessary in order to determine the campaign’s impact on outcomes of interest. Adding the two waves increases the target number of completed campaign questionnaires for all respondents to 107,743, an increase of 32,638 responses, and the annualized response burden to 15,135, an increase of 4,813 hours.

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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: 08/02/2018

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