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

ICR 201803-0910-004

OMB: 0910-0788

Federal Form Document

Forms and Documents
ICR Details
0910-0788 201803-0910-004
Historical Inactive 201708-0910-012
Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign.
Extension without change of a currently approved collection   No
Improperly submitted and continue 08/01/2018
Retrieve Notice of Action (NOA) 04/20/2018
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved 07/31/2018
75,105 0 75,105
10,322 0 10,322
0 0 0

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.

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

Not associated with rulemaking

  82 FR 61003 12/26/2017
83 FR 16863 04/17/2018

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.

Yes Part B of Supporting Statement
Amber Sanford 301 796-8867 [email protected]


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:
    (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;
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