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

ICR 201808-0910-001

OMB: 0910-0788

Federal Form Document

Forms and Documents
ICR Details
0910-0788 201808-0910-001
Historical Active 201803-0910-004
HHS/FDA CTP
Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign.
Reinstatement with change of a previously approved collection   No
Regular
Approved with change 08/03/2018
Retrieve Notice of Action (NOA) 08/02/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved
107,743 0 0
15,135 0 0
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
  
None

Not associated with rulemaking

  82 FR 61003 12/26/2017
83 FR 16863 04/17/2018
No

  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
No
No
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.

$8,996,243
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/02/2018


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